stroke practice guideline

TSR 13:2, Spring 2006

Contentsvii viii x 1 Foreword Information for Authors Letters to the Editors Ottawa Panel Evidence-Based Clinical Practice Guidelines for Post-Stroke Rehabilitation 3 Method4 4 5 5 7 7 9 9 Target population Literature search Study inclusion/exclusion criteria Post-stroke rehabilitation interventions Outcomes Statistical analysis Reviewing the guidelines Results of literature search

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Results10 Clinical practice guidelines for therapeutic exercises 14 Summary of trials 14 Efficacy 20 Strength of published evidence compared with other guidelines 20 Clinical recommendations compared with other guidelines Clinical practice guidelines for task-oriented training 24 Summary of trials 24 Efficacy 27 Strength of the published evidence compared with other guidelines 27 Clinical recommendations compared with other guidelines Clinical practice guidelines for biofeedback 30 Summary of trials 30 Efficacy 32 Strength of published evidence compared with other guidelines 33 Clinical recommendations compared with other guidelines Clinical practice guidelines for gait training 36 Summary of trials 37 Efficacy 40 Strength of published evidence compared to other guidelines 40 Clinical recommendations compared with other guidelines Clinical practice guidelines for balance training 43 Summary of trials 43 Efficacy 45 Strength of the published evidence compared with other guidelines 45 Clinical recommendations compared with other guidelines

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Clinical practice guidelines for sensory interventions 46 Summary of trials 46 Efficacy 48 Strength of the published evidence compared with other guidelines 48 Clinical recommendations compared with other guidelines Clinical practice guidelines for constraint-induced movement therapy 49 Summary of trials 49 Efficacy 50 Strength of published evidence compared with other guidelines 50 Clinical recommendations compared with other guidelines Clinical practice guidelines for shoulder subluxation 52 Summary of trials 52 Efficacy 53 Strength of published evidence compared with other guidelines 54 Clinical recommendations compared with other guidelines Clinical practice guidelines for electrical stimulation 56 Summary of trials 57 Efficacy 59 Strength of published evidence compared with other guidelines 60 Clinical recommendations compared with other guidelines Clinical practice guidelines for transcutaneous electrical nerve stimulation (TENS) 61 Summary of trials 62 Efficacy 63 Strength of published evidence compared with other guidelines 63 Clinical recommendations compared with other guidelines Clinical practice guidelines for therapeutic ultrasound 64 Summary of trials 64 Efficacy 64 Strength of the published evidence compared with other guidelines 64 Clinical recommendations compared with other guidelines Clinical practice guidelines for acupuncture 65 Summary of trials 66 Efficacy 67 Strength of the published evidence compared with other guidelines 67 Clinical recommendations compared with other guidelines Clinical practice guidelines for intensity and organization of rehabilitation 74 Summary of trials 75 Efficacy 83 Strength of published evidence compared with other guidelines 83 Clinical recommendations compared with other guidelines

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Discussion86 87 88 88 91 91 Therapeutic exercises Task-oriented training Biofeedback Gait training Balance training Sensory interventionsv

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Constraint-induced movement therapy Shoulder subluxation Electrical stimulation TENS Therapeutic ultrasound Acupuncture Intensity and organization of rehabilitation

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Conclusion Acknowledgments References

119 Appendixes

All figures and tables cited in this issue are included in the CD attached to the inside back cover. This CD also includes an electronic version of the full text of this issue with embedded hyperlinks to the figures and tables. Additional copies can be ordered at www.thomasland.com

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ForewordThe concept of developing and implementing clinical practice guidelines has received considerable attention in recent years among many medical professionals, clinical leaders, payers, and policy makers. It is interesting to note that adoption of these tools has been considerably less enthusiastic among rehabilitation programs and practitioners than among many other disciplines and professionals. Reasons for the slower utilization of guidelines are many, including concern that they might limit the important role of creativity and ingenuity in the clinical practice of rehabilitation, relative deficiency of sufficient evidence supporting many prevailing rehabilitation practices, and an apparent lack of compelling reasons for clinicians to examine the possibility of changing existing practices. There also is limited interest in the development and use of guidelines among rehabilitation professionals and a general lack of awareness of their usefulness among clinicians and their leaders. Although there are some notable prominent exceptions, clinical practice guidelines are in their infancy in rehabilitation. There is a school of thought that asserts that the experience of developing these guidelines is as important and beneficial as the actual implementation of these tools. The opportunity to thoroughly and critically review existing medical literature and assess its implications for clinical practice often is a unique and favorable collaborative experience for clinicians and scholars. However, it is in their roles in education and in promoting both quality and consistency of care that clinical practice guidelines demonstrate their greatest benefits. For trainees and for junior clinicians with minimal practical experience, these tools can be used as an effective training device. For all practitioners, they can be used as a template to ensure that favorable evidence-driven practices are being implemented. This is a method to improve quality of care. These documents are tools and, like other instruments used by clinicians, they serve to support and facilitate successful rehabilitation; they do not replace the role of originality and they do not reduce the value of hands-on, interactive, collaborative problem-solving by clinicians and patients that often is the hallmark of team-driven clinical stroke rehabilitation. Topics in Stroke Rehabilitation recently has published several Clinical Practice Guidelines (TSR 10:1 and 10:2 [2003], 11:4 [2004]). The frequency with which these documents are being published at this time reflects the emerging interest among thought leaders and practitioners in the performance and dissemination of comprehensive reviews of literature and in the implementation of clinical practices that are based on strong evidence, where it exists. In the present issue, Dr. Lucie Brosseau and her colleagues in Ottawa, Ontario, Canada, have conducted an exhaustive review of the literature, employed rigorous grading measures to rate the quality of the research studies, developed and applied a systematic method for organizing key points from the manuscripts that they reviewed, and created an extensive set of guidelines for clinical stroke rehabilitation practices that derive directly from these findings. The product focuses on 147 specific recommendations concerning 13 rehabilitation interventions. Practicing according to these guidelines can be expected to enhance the quality of care that is provided by clinicians and to improve the level of functioning that is experienced by patients. Dr. Brosseau and her team are to be congratulated for the enormous effort that was put into the production of this document, not only for their rigorous reviews and clear writing, but also because of the way in which the information is presented. Because the volume of material is potentially overwhelming, it could be somewhat unwieldy for most practitioners. This is one reason that the organization of the material is so relevant in order to facilitate understanding and use of the recommendations and their foundation. The managing editor, Mary Killion, also should be recognized for her extensive contribution to the layout and formatting of the data. The use of the CD-ROM is a novel approach. Displaying information in a tabular format is a sound way to promote understanding and learning. The enormity of the material necessitated an alternative additional method to disseminate the figures and tables of the reviewed literature. Using a CDROM seemed a sensible method to provide this material to you. Your comments on the text (and the format) are welcome. However, the true test of the success of the product is whether these guidelines are actually adopted in daily practice and the extent to which the content forms a basis of clinical practice in stroke rehabilitation. Elliot J. Roth, MD Co-Editor-in-Chief Topics in Stroke Rehabilitation Chicago, IL, USA January 2006

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Special Issue Ottawa Panel Evidence-Based Clinical Practice Guidelines for Post-Stroke RehabilitationThe Ottawa Panel*

Background and Purpose: The purpose of this project was to create guidelines for 13 types of physical rehabilitation interventions used in the management of adult patients (>18 years of age) presenting with hemiplegia or hemiparesis following a single clinically identifiable ischemic or hemorrhagic cerebrovascular accident (CVA). Method: Using Cochrane Collaboration methods, the Ottawa Methods Group identified and synthesized evidence from comparative controlled trials. The group then formed an expert panel, which developed a set of criteria for grading the strength of the evidence and the recommendation. Patient-important outcomes were determined through consensus, provided that these outcomes were assessed with a validated and reliable scale. Results: The Ottawa Panel developed 147 positive recommendations of clinical benefit concerning the use of different types of physical rehabilitation interventions involved in post-stroke rehabilitation. Discussion and Conclusion: The Ottawa Panel recommends the use of therapeutic exercise, task-oriented training, biofeedback, gait training, balance training, constraint-induced movement therapy, treatment of shoulder subluxation, electrical stimulation, transcutaneous electrical nerve stimulation, therapeutic ultrasound, acupuncture, and intensity and organization of rehabilitation in the management of post stroke. Key words: clinical practice guidelines, CVA, epidemiology, evidence-based practice, outcomes, physical rehabilitation, stroke

troke is the third cause of mortality in North America.1 Although approximately two thirds of stroke patients survive an initial stroke, nearly one half of survivors have physical disabilities as a result.2 Furthermore, while severe stroke incidence has decreased, milder stroke incidence with minimal and moderate deficits has increased. The individuals surviving a stroke

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require rehabilitation that includes varying degrees of medical care, rehabilitation, nursing, and other health professional care.3 Stroke survivors present sensorimotor, musculoskeletal, perceptual, and cognitive system deficits.4 Their impairments, disabilities, and handicaps can lead to devastating personal consequences as well as consequences for the health care system and society at large.

*Ottawa EBCPGs Development Group: Lucie Brosseau, PhD,1 George A. Wells, PhD,2,3 Hillel M. Finestone, MD,6 Mary Egan, PhD,1 Claire-Jehanne Dubouloz, PhD,1 Ian Graham, PhD,4 Lynn Casimiro, MA, Vivian A. Robinson, MSc,3 Martin Bilodeau, PhD,1 and Jessie McGowan, MLIS.3 External Panel Members: Robert Teasell, MD,10 Johanne Desrosiers, PhD,5 Susan Barreca, MSc,8 Lucie Laferrire, MHA,9 Joyce Fung, PhD,7 Hlne Corriveau, PhD, MHA,5 Gordon Gubitz, MD,11 Michael Sharma, MD,9 and Mr. S. U.12 Assistant Manuscript Writers: Amole Khadilkar, MD,1 Karin Phillips, MA,1 Nathalie Jean,1 Catherine Lamothe,1 Sarah Milne, MSc,1 and Joanna Sarnecka, MSc.1 School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada; 2Department of Epidemiology and Community Medicine, Univer1

sity of Ottawa, Ottawa, Ontario, Canada; 3Centre for Global Health, Institute of Population Health, Ottawa, Ontario, Canada; 4School of Nursing Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada; 5Research Centre on Aging and Sherbrooke University, Sherbrooke, Qubec, Canada; 6Sisters of Charity of Ottawa Health Service, Ottawa, Ontario, Canada; 7Department of Physical Therapy, McGill University, Montreal, Qubec, Canada; 8Hamilton Health Sciences, Hamilton, Ontario, Canada; 9Regional Stroke Centre, Ottawa Hospital, Ottawa (Ontario), Canada; 10University of Western Ontario, London, Ontario, Canada; 11Division of Neurology, Dalhousie University, Halifax (Nova Scotia), Canada; 12Patient who had a stroke.

Top Stroke Rehabil 2006;13(2):1269 2006 Thomas Land Publishers, Inc. www.thomasland.com

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TOPICS IN STROKE REHABILITATION/SPRING 2006

Post-stroke physical rehabilitation interventions have been used to reduce pain and spasticity, as well as to increase range of motion (ROM), muscle force, mobility, walking ability, functional status, physical fitness, and quality of life. Post-stroke physical rehabilitation interventions are mostly noninvasive interventions that present very few adverse side effects and contraindications as compared with a large number of pharmacologic interventions. Despite the fact that significant progress has been made in the clinical management of stroke over the last decade, there is an urgent need for physicians, nurses, physiotherapists, occupational therapists, and other rehabilitation specialists to provide the most efficient and effective treatments for their patients. Evidence-based clinical practice guidelines (EBCPGs) have been defined as systematically developed statements to help practitioners and patients with decisions about appropriate health care for specific clinical circumstances.5 EBCPGs are a rapidly emerging technology with considerable potential to alter the clinical decision-making process in fundamental ways. The appropriate use of guidelines has been demonstrated to improve both the process of care and patient health outcomes.6 EBCPGs allow stroke patients to benefit maximally from the physical rehabilitation treatment that they are receiving. There are currently many systematic reviews and meta-analyses on the effectiveness of poststroke physical rehabilitation interventions in the scientific literature. (Summarized comparative results of these reviews are included in the Discussion section.) Trials on the efficacy of the following types of therapeutic exercises for stroke survivors have been systematically reviewed: physical fitness,7,8 therapeutic exercise,914 task-oriented training,15 progressive strengthening exercise,16,17 robot-aided training,18,19 and constraint-induced movement therapy.2023 Four meta-analyses have been published2427 for the effect of the intensity of rehabilitation following stroke, while reviews on different aspects of gait training,28 such as the use of the treadmill combined with body support,2935 have also been done. Both Barclay-Goddard35 and Pollock36 have systematically reviewed balance

training. Furthermore, the efficacy of organization and intensity of stroke rehabilitation has been examined through systematic reviews.3744 Several meta-analyses, systematic reviews, and literature reviews have been conducted over the last 7 years on the effectiveness of EMG biofeedback (EMG-BFB). One examined EMG-BFB for neuromuscular reeducation,45 and others looked at EMG-BFB for the improvement of upper extremity function.4648 Finally, Moreland et al.49 examined the use of EMG-BFB to improve lower extremity function after stroke. These publications, though recent, require updating because of the rapidly growing number of scientific articles published on the effectiveness of EMG-BFB.50,51 Moreover, one of the studies45 has been criticized for failing to perform a sensitivity analysis on the control group.49 Follow-up of drop-outs was also lacking.49 EMG-BFB constitutes a small but effective part of lower extremity physical rehabilitation in stroke patients. Functional electrical stimulation (FES) has also been systematically reviewed for post-stroke patients.5260 A recent review was conducted on the management of shoulder pain and subluxation.61 63 Meta-analyses on post-stroke pain management were done for acupuncture as an adjuvant therapy in stroke rehabilitation.6467 However, several trials of electroanalgesia could have been added to this review.68,69 To our knowledge, no published systematic review exists concerning the efficacy of therapeutic electrotherapy modalities. It is evident that the post-stroke physical rehabilitation literature has been exhaustively reviewed. However, the methodology used in these reviews needs to be standardized (e.g., selection criteria) and quantified (e.g., Cochrane Collaboration), and the results of most of these reviews also need to be updated in order to be included in the development of EBCPGs. Several multidisciplinary EBCPGs have been published on post-stroke rehabilitation.7078 However, the Agency for Health Care Policy and Researchs (AHCPRs) EBCPGs were developed for limited clinical practice areas.70 They did not provide a clear definition of physiotherapy or review specific physical rehabilitation interventions. They also failed to use a rigorous grading system to

Clinical Practice Guidelines

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assess the evidence. Guidelines were based mainly on committee opinions and have not been recently updated.79 Other EBCPGs7278 are also available for rehabilitation specialists. Although the review of the literature and selection of stroke topics is exhaustive in these guidelines, the evaluation of the evidence is based upon descriptive conclusions of the primary studies rather than a quantitative analysis of the raw data. These guidelines use a grading system that takes the research design of the studies into account, but not the clinical significance of the outcomes. Except for the guidelines from the Heart and Stroke Foundation of Ontario,71 these EBCPGs do not base their assessment of the level of evidence on a quantitative synthesis using the raw data of the studies of interest, such as proposed by the Cochrane Collaboration methodology. These analyses are also not pooled to specific outcome measures. The conclusions of most of these EBCPGs concerning the effectiveness of the selected post-stroke interventions are often imprecise and difficult to apply to the daily practice of rehabilitation practitioners. The advantage of the proposed Ottawa Panel EBCPGs8082 on post-stroke physical rehabilitation interventions is that they offer graded, quantitative,83 and high-quality84 recommendations that indicate the treatment time for which a specific intervention is optimally effective for a specific outcome for a particular stroke population. The generally positive (small-to-large effect sizes from quantitative reviews) results from the recent meta-analyses coupled with the lack of up-to-date, rigorously developed EBCPGs on physical poststroke rehabilitation interventions suggest the need for the development of better quality EBCPGs for these interventions. Furthermore, evidence suggests that quality of care can be improved through the use of EBCPGs.8589 The purpose of developing these guidelines is to promote the appropriate use of various physical rehabilitation interventions in the management of stroke survivors. These guidelines are aimed at various users, including physical therapists, occupational therapists, physicians, and patients. This article discusses only post-stroke physical interventions such as therapeutic exercises, task-oriented training, biofeedback, gait training, balance training,

sensory interventions, constraint-induced movement therapy (CIMT), treatment of shoulder subluxation, electrical stimulation, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, acupuncture, and intensity and organization of rehabilitation. Method The development process of these EBCPGs was similar to that of the Philadelphia Panel90 and to previous Ottawa Panel publications,81,82 except that a different target population was used. Briefly, the Ottawa Methods Group (OMG), a group of 10 methodologists with experience in developing EBCPGs, asked professional associations interested in the care of stroke patients to suggest individuals with both clinical expertise in the management of stroke and familiarity with EBCPGs. From among the suggestions, the OMG chose nine experts (R.T., G.G., J.D., J.F., H.C., S.B., L.L., M.S., S.U.) to serve as panel members. The professional experts were recruited from multidisciplinary disciplines such as physical medicine, neurology, occupational therapy, and physical therapy. Several experts (R.T., G.G., J.D., J.F., S.B., L.B., A.H.) are members of the Canadian Stroke Network,91 while some had already developed post-stroke rehabilitation EBCPGs (R.T., S.B.). The Ottawa Panel consisted of these nine experts, in addition to all the members of the OMG. The OMG assembled a research and support staff with expertise in meta-analyses, stroke rehabilitation interventions, research methods, or the development and assessment of EBCPGs. The OMG then established an a priori set of inclusion criteria for the study designs, subject samples, interventions, and outcomes to allow the research staff to select the most relevant material as evidence for the effectiveness of various rehabilitation interventions for post-stroke patients. The OMG also reviewed the inclusion criteria to ensure that the approach to the study selection was reproducible and systematic. This a priori protocol guided separate systematic reviews of the literature for each intervention. The OMG also made sure that the Ottawa Panel EBCPGs were methodologically

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developed at high level of quality, according to AGREE (www.agreecollaboration.org) criteria.84 The research staff reviewed articles and created draft evidence tables, which the nine clinical experts received in preparation for their consensus meeting with the OMG. These tables were used as the basis for making the Ottawa Panel recommendations.Target population

The target population was adult patients (>18 years of age) presenting with hemiplegia or hemiparesis following a single clinically identifiable ischemic or hemorrhagic CVA. The patients had to be medically stable and able to follow simple instructions and to interpret and respond to feedback signals. The mean duration since stroke onset varied from hyper-acute (the first 12 hours), acute (first week following a stroke), subacute (from the first to 6th week), and post-acute (from 6 weeks to 6 months) to chronic (from 6 months) as defined by the Canadian Stroke Network (Appendix 3: Characteristics of Included Studies).91 Patients who had been identified as having multiple CVAs, other neurological problems (e.g., Parkinsons, brain tumors, traumatic brain injury), subarachnoid hemorrhages, or subdural hematomas were excluded because of the numerous and varied associated signs and symptoms. Studies that included patients with bilateral neurological signs were also excluded. Further exclusion criteria included studies whose patients presented with one of the following conditions: (1) cancer or other oncological conditions, (2) cardiac conditions, (3) dermatologic conditions, (4) healthy normal subjects, (5) serious cognitive deficits or severe communication problems, (6) major medical problems that could interfere with the rehabilitation pfOcess or incapacitate functional status, or (7) psychiatric conditions. Further inclusion and exclusion criteria are exhibited in Table 1.Literature search

The library scientist developed a structured literature search based on the sensitive search strategy recommended by The Cochrane Collaboration92 and modifications to that strategy proposed

by Haynes et al.93 The Cochrane Collaboration method minimizes bias through a systematic Z proach to the literature search, study selection, and data extraction and synthesis. The search was organized around the condition and interventions rather than the outcomes because it was an a priori search. Thus, we had no control over the outcomes that the authors of the primary studies decided to measure (Appendix 1: Literature Search Results). The library scientist expanded the search strategy to identify case control, cohort, and non-randomized studies and conducted the search in the electronic databases of MEDLINE, EMBASE, Current Contents, the Cumulative Index to Nursing and Allied Health (CINAHL), and the Cochrane Controlled Trials Register up to December 2004. She also searched the registries of the Cochrane Field of Rehabilitation and Related Therapies, the Cochrane Musculoskeletal Group, the Physiotherapy Evidence Database (PEDro), and the University of Ottawa EBCPGs Web site. Finally, she searched the reference lists of all of the included trials for relevant studies and contacted content experts for additional studies. In the first round of study inclusion or exclusion, two trained independent reviewers appraised the titles and abstracts of the literature search, using a checklist with the a priori defined selection criteria (Table 1). For each pair of reviewers, individuals independently read the title and abstract of each article and created a list of all of the articles in the database along with a reason for either including or excluding each article. If the reviewers were uncertain about a particular article after having read the abstract, they ordered the article and read it in full before making a determination. Before deciding whether to include or exclude the article, a comparison of their individual lists was performed. A senior reviewer, a methodologist and a clinical expert (L.B.), checked the two independent lists of articles and the reasons for inclusion or exclusion to determine potential inconsistencies. Seven percent of the abstracts needed the consultation of the senior reviewer and an additional review of the problematic article. For the second round of the inclusion and exclusion process, the pairs of reviewers retrieved articles selected for inclusion from the first round and inde-


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pendently assessed the full articles for inclusion or exclusion in the study. Using predetermined extraction forms, the pairs of reviewers independently extracted from included articles data on the population characteristics, details of the interventions, trial design, allocation concealment, and outcomes. The pairs of reviewers assessed the methodological quality of the studies using the Jadad Scale,83,94 a 5-point scale with reported reliability and validity that assigns 2 points each for randomization and double blinding and 1 point for description of withdrawals. The reviewers resolved differences in data extraction and quality assessment through consensus with the senior reviewer. This consensus served to support the reliability of data obtained with the article selection process.Study inclusion/exclusion criteria

drop-out rate or a sample size of fewer than 5 patients per group. Trials published in languages other than French and English were not analyzed, because of the additional time and resources required for translation. Abstracts were excluded if they contained insufficient data for analysis and additional information could not be obtained from the authors. For further exclusion criteria, see Table 1.Post-stroke rehabilitation interventions

The inclusion/exclusion criteria were based upon previous criteria used by the Philadelphia Panel.90 This list of criteria, which had been created for multiple diagnoses, was adapted and approved by the OMG for use with patients post stroke (Table 1). All original comparative controlled studies that evaluated relevant physical rehabilitation interventions in stroke patients were included: randomized controlled trials (RCTs), controlled clinical trials (CCTs),* cohort studies, and case-control studies. Crossover studies were included, but to avoid potential confounding carry-over effects the data from only the first part of the study (before crossing) was analyzed. Studies where patients served as their own controls were excluded. No limitations based on methodological quality were imposed a priori with regard to the selection of comparative controlled studies; however, the quality of the studies was considered when grading the recommendations resulting from our analysis. Uncontrolled cohort studies (studies with no comparison group) and case series were excluded, as were eligible studies with greater than a 20%*Controlled clinical trials are considered the same as randomized control trials (RCTs). However, according to the Jadad Scale,94 CCTs are either not randomized or have not been appropriately randomized.

Post-stroke rehabilitation interventions were identified as therapeutic exercises, task-oriented training, biofeedback, gait training, balance training, sensory information, CIMT, treatment of shoulder subluxation, electrical stimulation, TENS, therapeutic ultrasound, and acupuncture. Intensity and organization of rehabilitation was also included as an intervention related to stroke rehabilitation. Post-stroke rehabilitation interventions related to therapeutic exercises were identified as aerobic training, resistance training, passive range of motion exercises, proprioceptive neuromuscular facilitation, Bobath technique, kinetron, and the use of the overhead pulley.95 They are defined as follows. Aerobic training is considered to be activities to increase endurance and cardiovascular function. Resistance training was defined as active exercise done against a resistance. Passive range of motion exercises were defined as physiological mobilization done by the therapist without any effort from the patient. Proprioceptive neuromuscular facilitation was identified as the use of mostly reflex-inhibiting patterns. Bobath technique was defined as a neurodevelopmental technique using inhibitory posture and movement to inhibit spasticity and synergies, while facilitating normal movements. Kinetron training was defined as training with this resistive lower extremity machine, usually in isokinetic mode. Rehabilitation interventions related to task-oriented training were identified as treatments that involved dividing activities of daily living into component parts. Individual components of the larger task were then practiced until the patient was able to complete the component adequately.

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Component parts were then combined, and the overall skill was practiced with repetition. Any intervention that divided required tasks into individual skills was included.95 We included tasks such as seated reaching tasks, adapted games, and repetitive elbow joint movements. Post-stroke rehabilitation interventions related to biofeedback were identified as EMG-BFB, EMGbiofeedback-relaxation training, rhythmic positional biofeedback, audio and visual feedback, video feedback, and force feedback. EMG-BFB was defined as an intervention that allows a patient to monitor his or her muscle activity through electrodes with a visual or audible feedback signal.95 Rhythmic positional biofeedback was defined as a usual biofeedback intervention with auditory or visual stimuli aimed at increasing the rhythm of movement. Audio and visual feedback were identified as any cue received by the patient during or after the exercise. Video feedback was considered to be a visual cue from a monitor after the action was done. Force feedback was defined as feedback related to the moment of force. Rehabilitation interventions associated with gait training were identified as treadmill training, overground training, body weight support training, brace-assisted walking, electrogoniometric feedback training, FES, rhythmic auditory facilitation training, and functional lower extremity training. Treadmill training was defined as ambulation on a treadmill adjusted to patients comfortable walking speed or highest speed as possible for the patient. Overground training was defined as gait training on an even surface with propulsion forward, backward, and sideways or going up and downstairs. Body weight support training was defined as treadmill training, while an overhead harness supported a percentage of the body weight. Brace-assisted walking was defined as use of hemibar and ankle-foot orthosis (AFO) or any other type of brace if necessary. Electrogoniometric feedback training was defined as auditory feedback during gait training when patient was compensating in hyperextension or flexion. FES was defined as electrical stimulation of a specific muscle or nerve such as tibialis anterior or peroneal nerve for a functional purpose to improve swing phase or stance phase during gait. Rhythmic auditory facilitation training was defined as imposed rhythm to

improve gait rhythm and frequency. Functional lower extremity training was defined as functional tasks such as sitting, standing, climbing stairs, transfers, and gait with a focus on the recovery of stability and gait performance. Rehabilitation interventions related to balance training were identified as any intervention that contributes to the enhancement of equilibrium and balance in post-stroke patients. We included interventions such as base of support training and platform training. Rehabilitation interventions related to sensory interventions were identified as any retraining of the sensory and visuo-spatial function to correct posture and perceptual problems after stroke,95 such as passive vestibular stimulation, perceptual learning exercises, and rocking chair stimulation. Rehabilitation interventions associated with CIMT were defined as the restriction of the nonparetic upper extremity by a sling or hand splint to encourage the use of the paretic limb. Functional exercises were given to the patient to improve the function of the affected arm. Post-stroke rehabilitation interventions related to treatment of shoulder subluxation were identified as FES, supports methods, strapping, and shoulder positioning. FES was defined as electrical stimulation of a specific muscle or nerve such as supraspinatus or middle deltoid with functional purpose resulting in the reduction of shoulder subluxation. Support methods were defined as any use of an external support such as orthosis or sling to prevent shoulder subluxation. Strapping methods were defined as strapping used to keep the glenohumeral joint in normal position. Shoulder positioning was defined as a position induced by the physiotherapist to protect the structures around the weak hemiplegic shoulder in order to avoid shoulder pain and shoulder subluxation. Post-stroke rehabilitation interventions related to electrical stimulation were identified as FES, neuromuscular electrical stimulation (NMES), positional feedback stimulation training, EMGtriggered electrical muscle stimulation, and TENS. FES was defined as the electrical stimulation of a specific muscle or nerve such as tibialis anterior and gastrocnemius for a functional purpose, such as gait training. Neuromuscular electrical stimulation (NMES) was defined as electrical


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stimulation of a specific muscle or nerve such as thumb flexors and extensors to help trigger nervous fibers and achieve motor recovery. Positional feedback stimulation training was defined as auditory and visual feedback during training to achieve a target position of the joint. EMG-triggered electrical muscle stimulation was defined as electrical stimulation of a muscle triggered by EMG activity of this muscle. TENS was defined as a form of electrical stimulation that triggers nervous endings to inhibit the message of pain. TENS is identified as being given at high- and low-intensity levels. Ultrasound was identified as an electrophysical modality using an ultrasonic wave to treat a specific area, usually for pain, and indirectly for ROM. Post-stroke rehabilitation interventions related to acupuncture were identified as any treatment using needles to stimulate specific anatomical point with the hands or with electrical stimulation. Post-stroke rehabilitation interventions related to the intensity and organization of rehabilitation were identified as examining the rate, frequency and rigor of any physical rehabilitation intervention or combination of interventions in the treatment of post-stroke patients. 95 Interventions such as stroke unit care, enhanced physical therapy, enhanced occupational therapy, enhanced upper extremity treatment, and intensive outpatient physiotherapy rehabilitation were included as part of intensity and organization of post-stroke rehabilitation. Acceptable comparisons were placebo, no treatment, or use of educational pamphlets. Studies designed with a comparison of two interventions instead of treatment versus control were included as long as both interventions respected the inclusion criteria. Concurrent therapies (such as medication) were accepted only if they were provided to both the experimental and control groups. Study selection was not restricted by the cost, complexity, or general availability of equipment and resources required to carry out the interventions under investigation.Outcomes

posal of the International Classification of Functioning, Disability and Health, which involved the concepts of body function, body structure, activities and participation, and environmental factors. The a priori outcomes were classified according to two WHO concepts: (1) Body function: pain reduction, muscle strength, motor function/motor recovery, ROM, postural status, balance status, gait status, cadence, stride length, sensory status, spasticity/muscle tone, global physician assessment, global patient assessment, and cardiopulmonary function. (2) Activities and participation: walking speed, walking distance, endurance, functional status, patient adherence, patient satisfaction, length of stay, discharge disposition, quality of life, and return to work. Studies were included if any one of the aforementioned outcomes was measured. A positive recommendation was made only if a specific intervention was effective for an outcome, as measured by a validated scale. Psychological outcomes such as depression were excluded (Table 1).Statistical analysis

The outcomes were selected and based upon the World Health Organizations96 (WHOs) new pro-

The data were analyzed using Review Manager Software.97 Continuous data, data with a potentially infinite number of possible values along a continuum, 98 were analyzed using the weighted mean differences (WMDs) between the intervention and control groups at the end of the study, where the weight is the inverse of the variance. A WMD is a method of meta-analysis used to combine measures on continuous scales (such as weight), where the mean, standard deviation and sample size in each group are known. 98 Dichotomous data or data with only two classifications98 were analyzed using relative risks. According to Cochrane, the relative risk is the ratio of risk in the intervention group to the risk in the control group. The risk (proportion, probability, or rate) is the ratio of people with an event in a group to the total in the group. 98 Heterogeneity (i.e., variability or difference in estimated effects between studies) was tested using the chi-square statistic. We tested data heterogeneity across the results of different included studies. When heterogeneity was not significant, fixed-ef-

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fect models were used. A fixed-effect model is a statistical model that stipulates that the units under analysis (e.g., participants in a meta-analysis study) are the ones of interest and thus constitute the entire population of units. Fixed-effect models were used to generalize data across the included studies. Random-effects models include both within-study sampling error (variance) and between-study variation in the assessment of the uncertainty (confidence interval) of meta-analysis results. Such random-effects models were used when heterogeneity was significant. All figures were created using Cochrane Collaboration methodology (www.cochrane.org). The square in TE-Figure 1A. illustrates the WMD between the two groups, when they are compared for a specific outcome of interest. The horizontal line represents the standard deviation of the WMD. If the standard deviation line touches the central vertical line of the graph, the confidence interval contains a zero and the difference between the two groups is not statistically significant. For example, in TE-Figure 1A that illustrates the comparison between aerobic training and a control group where gait speed at end of treatment is the outcome measure, the gait speed of the group receiving the aerobic training is not statistically different from that of the control. Based on previous Philadelphia and Ottawa Panels consensus,8082 clinical improvement for all interventions studied by the Ottawa Panel was defined as 15% improvement, relative to a control. To determine clinical improvement, the absolute benefit and relative difference in the change from baseline were calculated. Absolute benefit was calculated as the improvement in the treatment group minus the improvement in the control group, maintaining the original units of measurement. The relative difference (RD) was calculated as the absolute benefit divided by the baseline mean (weighted for the intervention and control groups). For dichotomous data, the relative percentage of improvement was calculated as the difference in the percentage of improvement between the intervention and control groups.80 However, during this meta-analysis, four special cases of calculation appeared where new formulas were needed to calculate the RD in the change from baseline. The first case occurred when the baseline values were not available for an outcome. The second scenario involved an outcome that was

measured as a change from baseline, where the scale of measurement was known but baseline values were absent. The third case encountered was also where the outcome was measured as a change from baseline but both the baseline values and the measurement scales were either not available or were nonexistent (e.g., no measurement scales exist for strength). Finally, in the fourth case, where the baseline mean was given as 0, a sum of 1 was added to all the values in the formula of clinical relevance, based upon the following assumption: the mean of scale + 1 = mean of original scale + 1 and SD of scale + 1= SD of original scale. The new formulas used to calculate the relative difference in change from baseline for each of the four aforementioned scenarios are given in Appendix 2. The recommendations were graded by their level (I for RCTs, II for nonrandomized studies) and strength (A, B, C+, C, or D) of evidence. Evidence from one or more RCTs of a statistically significant, clinically important benefit (>15%) was necessary for a grade A recommendation. A grade B recommendation was given for a statistically significant, clinically important benefit (>15%), if the evidence was from observational studies or CCTs. Evidence of clinical importance (>15%) but not statistical significance earned a grade C+ recommendation. A grade C recommendation was given to those interventions where an appropriate outcome was measured in a study that met the inclusion criteria, but no clinically important difference and no statistical significance were shown. Evidence from one or more RCTs of a statistically significant benefit favoring the control group ( 1 year after stroke) and matched controls. Aging Clin Exp Res. 2005;17:7481. 595. Harris JE, Eng JJ, Marigold DS, Tokuno CD, Louis CL. Relationship of balance and mobility to fall incidence in people with chronic stroke. Phys Ther. 2005;85(2):150158. 596. Perell KL. Nelson A. Goldman RL. Luther SL. PrietoLewis N. Rubenstein LZ. Fall risk assessment mea-


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Appendixes120 122 123 145 158 177 192 199 204 207 212 219 222 223 227 263 APPENDIX 1. APPENDIX 2. Literature Search Results Special Formulas for Clinical Relevance APPENDIX 3A. Characteristics of Included Studies for Therapeutic Exercise APPENDIX 3B. Characteristics of Included Studies for Task-Oriented Training APPENDIX 3C. Characteristics of Included Studies for Biofeedback APPENDIX 3D. Characteristics of Included Studies for Gait Training APPENDIX 3E. Characteristics of Included Studies for Balance Training APPENDIX 3F. Characteristics of Included Studies for Sensory Interventions APPENDIX 3G. Characteristics of Included Studies for Constraint-Induced Movement Therapy APPENDIX 3H. Characteristics of Included Studies for Shoulder Subluxation APPENDIX 3I. Characteristics of Included Studies for Electrical Stimulation APPENDIX 3J. Characteristics of Included Studies for Transcutaneous Electrical Nerve Stimulation (TENS) APPENDIX 3K. Characteristics of Included Studies for Ultrasound APPENDIX 3L. Characteristics of Included Studies for Acupuncture APPENDIX 3M. Characteristics of Included Studies for Intensity and Organization of Rehabilitation APPENDIX 4. Existing Guidelines on Stroke Rehabilitation

119

APPENDIX 1. Literature Search Results

120

Data base: Medline Results 37 38 (retrospective or case-control).tw. or/23-37 STUDY FILTER (LINES 2338) 22 and 38 COMBINATION OF STROKE, PHYSIO/REHAB AND STUDY FILTER (LINE 39) 1482 80997 899180 SET Search Results

SET

Search


1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 10495 4 70 388 22364 31287 122 18150 204 573 72 1540 3731 20806 433

exp cerebrovascular disorders/ (stroke or cerebrovascular or cerebral vasc (tia or transient ischemic attach$ or trans (cerebral hemorrhage or cerebral haemorrhag (intracerebral hemorrhage or intracerebral cva.tw. hemiplegia.tw,sh. (cerebr$ or cerebellar of brain$ or vertebr (inract or schaemia or schemia or thrombo 8 and 9 (cerebral or intracerebral or intracranial (hemorrhage or haemorrhage or hematoma or b 11 and 12 or/1-7 10 or 13 or 14 STROKE TERMS (LINES 115) gait.tw,sh. ambulation disorders$.tw. locomot$ disorders.tw. cadence.tw. exp locomotion/ or/40-44 39 and 45 activities of daily living/ task-oriented.tw. task-related.tw. ability focus$.tw. adl.tw. (activities adj2 living) .tw. or/47-52 39 and 53 TOTAL FOR GAIT = 433 (LINE 54) biofeedback (psychology) / biofeedback.tw. electromyography/ (electromyography or emg).tw. muscle contraction.tw. muscle relax$.tw. spastic$ control.tw. motor skills/ motor control.tw. neuromuscular.tw. or/55-64 39 and 65 TOTAL FOR BIOFEEDBACK = 131 (LINE 66) 6299 284041 131937 192625 53060 61787 7154 5900 152 102 1761 3462 366379 159080 169449

131948 54754 1510 1885 2130 717 7741 435874 206602 26108 428049 108140 21288 162100 172152

16 17 18 19 20 21 55 56 57 58 59 60 61 62 63 64 65 66

exp physical therapy/ 71533 rh.fs 77687 (physical therapy or physiotherap$). Tw. 8037 rehabilitation/ 7823 rehabilit$.tw. 38359 or/16-20 162841 PHYSIO AND REHABILITATION TERMS (LINES 1621)

3629 2613 37921 15673 5615 6196 12 9717 1894 19228 82304 131

22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

15 and 21 clinical trial . Pt. randomized controlled trial.pt. random$.tw. (double adj blind$).tw. placebo$.tw. meta-analysis.pt,sh. (meta-anal : or metaanal:).tw. (quantitativ: review: or quantitativ: overv (methodologic: review: or methodologic: ove (systematic: review: or systematic: overvie review.pt. And medline.tw. exp cohort studies/ (cohort or longitudinal or prospective).tw. exp case-control studies/

continues

APPENDIX 1. ContinuedResults 9148 450623 23153 1686 156 1601 769 65 204406 6920 231 669977 368 104 105 106 107 108 constraint.tw. (functional training or functional retraining) functional therap$.tw. or/104-106 39 and 107 TOTAL FOR FUNCTIONAL TRAINING = 6 (LINE 108) 2633 57 220 2910 6 94 95 96 97 98 99 100 101 102 103 cryotherapy.tw,sh. 2594 ice.tw 5933 sensory stimulation.tw. 826 (tactile or brush$ or touch$ or cutaneous). 72059 physical stimulation/ 7702 postural control.tw. 594 acoustic stimulation/ 14745 photic stimulation 15537 or/94-101 115884 39 and 102 23 TOTAL FOR CYROTHERAPY AND STIMULATION = 23 (LINE 103) SET Search Results

SET

Search

67 68 69 70 71 72 73 74 75 76 77 78 79

exp electric stimulation therapy/ ((electric$ adj nerve) or therapy).tw. (electric$ adj (stimulation or muscle)).tw. electrostimulation.tw. electroanalgesia.tw. (tens or altens).tw. electroacupuncture.tw. neuromusc$ electric$.tw. (high volt or pulsed or current).tw. (electromagnetic or electrotherap$).tw. ionophoresis.tw. or/67-77 39 and 78 TOTAL FOR PAIN CONTROL USING TENS, ELECTROSTIMULATION ETC. = 368 (LINE 79) 20344 5446 107270 128546 272

80 81 82 83 84

length of stay/ length stay.tw. (program or session).tw. or/80-82 39 and 83 TOTAL FOR LOS = 272 (LINE 84) 69577 61944 17708 16 109 110 111 112 113 114 115

85 86 87 88

exp leg/ (leg or ankle or foot or feet).tw. 85 and 86 39 and 87 TOTAL FOR LOWER EXTREMITIES = 15 (LINE 88 ) 9233 7624 4502 19681 49

exp exercise therapy/ (therap$ adj2 exercise$).tw. aerobics.tw. (endurance adj2 therap$).tw. breathing exercise$.tw. or/109-113 39 and 114 TOTAL FOR EXERCISE THERAPY = 70 (LINE 115)

11322 1771 20486 16 293 32424 70

89 90 91 92 93

facilitation.tw. range of motion, articular/ range motion.tw. or/89-91 39 and 92 TOTAL FOR FACILITATION AND ROM = 49 (LINE 93)

Appendixes

116 117 118 119 120 121 122 123 124

exp arm/ shoulder.sh,tw. arm.tw,sh. wrist.tw,sh hand.tw,sh forearm.tw,sh elbow.tw,sh or/116-122 39 and 123 TOTAL FOR UPPER EXTREMITIES = 166 (LINE 124)

62019 16097 43127 10814 121408 15901 8974 209310 166

121

122


APPENDIX 2. Special Formulas for Clinical Relevance

Regular case Clinical relevance formula: (et bt) (ec bc) ( (bt * nt) + (bc * nc) ) / (nt + nc)Legend: et = end of study value for treatment bt = baseline value for treatment ec = end of study value for control bc = baseline value for control nt = number of patients in treatment group nc = number of patients in control group

Special case #1 When the baseline value was not available for an outcome, a formula was used to calculate the relative difference in the change from baseline: et ec (nt * et + nc * ec) / (nt + nc)Legend: et = end of study value for treatment ec = end of study value for control nt = number of patients in treatment group nc = number of patients in control group

Special case #2 When the outcome measure was given as a change from baseline value and the baseline value itself was not given, but the scale was known, a formula was used to calculate the relative difference in change from baseline: t cLegend: t = change in the value from treatment c = change in the value from control

Special case #3 When the outcome measure was given as a change from baseline value, where the baseline value was not given and the scale was unknown or nonexistent, a formula was used to calculate the relative difference in the change from baseline: t c (nt * t + nc * c) / (nt + nc)Legend: t = change in the value from treatment c = change in the value from control nt = number of patients in treatment group nc = number of patients in control group

Special case #4 When the baseline mean was 0, we added a sum of 1 to all the values in the formula of clinical relevance based on the assumption that: Mean of Scale + 1 = Mean of original scale + 1 and SD of Scale + 1 = SD of original scale.

APPENDIX 3A. Characteristics of Included Studies for Therapeutic Exercise

Author and year Comparison group All patients received Gr1: 4 to 5 standard customary hr/wk until care. discharge None Gr1: 2.8 wk SD: 1.1 wk Gr2: 3.3 wk SD: 1.2 wk Subacute Gr2: 63.3 SD: 10.6 Gr1: 58.5 SD: 8.3 Gr1: Patients hands and wrists were held in a rigid support affixed to the robotic arm. Therapy consisted of flexion, extension, and rotation movements across elbow and shoulder joints. These arm movements are goal-directed and robotassisted, and the therapy uses a computer-generated video program that provides visual and auditory feedback. If the arm was paralyzed, the robot initiated the movement passively. As function returned, the patient initiated more often. Gr1: Same aerobic protocol as Gr2; 8 different strength training exercises: chest press, seated row, leg press, leg curl, triceps press down, biceps curl, shoulder front raise; 2 sets of 10 repetitions; free weights and isokinetic machines; and flexibility exercises. Gr2: 20 min of aerobic exercise on a upper and lower body ergometer. N/A 3 days/wk for 16 wk N/A Gr2: Weekly to biweekly contact with the robotic device. Patients actively moved the robotic arm and were able to observe the response on the video monitor. The robotic device was also used to record strength and quality of movement. 0, 1, 1

Sample size

Symptom Population details duration

Age, yr (mean, SD for control) Treatment Concurrent therapy Follow-up duration Quality (R, B, W)

Session frequency and duration

Aisen 199799 Total: 20 Gr1: 10 Gr2: 10

Inclusion: Patients with hemiplegia admitted to the same medical ward and team of Burke Rehabilitation Hospital, White Plains, NY, 3 wk; and who had SD of 1 wk after a single stroke. Hemiplegia: Gr1: 3 R; 7 L Gr2: 1 R; 9 L Treated area: Affected upper extremity Greater than 6 months 3082 yr

Carr 2003100 Total: 40

Stroke survivors whose ages ranged from 30 to 82 yr

1, 0, 0

Appendix 3A 123

continues

APPENDIX 3A. Continued

124

Author and year Comparison group 8 wks, 3 days/ N/A wk, 1 hr/session Gr1: 3.0 yr SD: 2.0 yr Gr2: 4.2 yr SD: 2.1 yr Gr2: 63.4 SD: 8.4 Gr1: 61.9 SD: 9.4 Gr1: Main objective: improve cardiovascular fitness in stroke patients after 8 wk of intensive water-based exercise in chest-level water. Intervention: 10 min of land-based stretching, 5 min of light aerobic warm-up in water (marching on the spot, single- and doublelegged hopping holding onto the pool edge), 30 min of moderate to high aerobic activities (shallow water walking, running, side stepping) at target heart rate prescribed for that wk (50% to 70%, 75% and 80% heart rate reserve +/ 5 beats/min for wk 12, 35, and 68, respectively), 5 min light cool down (marching on the spot), and 10 min gentle stretching in the water. Gr2: Main objective: N/A improve upper extremity function. Each session: 5-min warm-up of active upper extremity movement, 6-station (7-min stations) circuit focused on gross upper limb movement (reaching), fine motor movement (adjusting small screws and bolt), and muscle strengthening of the upper extremity (using hand putty, theraband, weights), 5-min cool-down from upper extremity exercises. 2, 0, 1

Sample size





Chu 2004101 Total: 12 Gr1: 7 Gr2: 5

At least 1 yr poststroke from a single CVA; independent in walking (with or without assistive device); medically stable; no previous myocardial infarction; no significant musculoskeletal problems from conditions other than stroke. Hemiplegia: Gr1: 4 R; 3 L Gr2: 3 R; 2 L

Dickstein 1986102

Total: 131 Gr1: 36 Gr2: 38 Gr3: 57

Hemiplegic patients 16 days who had had a recent stroke. Hemiplegia: 62 L; 66 R 3 bilateral

70.5 SD: 7.65

Gr1: Proprioceptive neuromuscular facilitation (PNF): Reflexes (most commonly the stretch reflex) frequently were used to elicit movements. Mass-movement patterns, such as diagonal and spiral patterns and total patterns of the development sequence formed an integral part of the exercises. Gr2: Bobath: First step of treatment sessions was geared toward the inhibition of abnormal muscle tone, usually through application of appropriate reflex-inhibiting patterns. This was performed concurrently with an effort to initiate normal movements (automatic and voluntary). Through key points of control in patients bodies. Imposition activity such as effort to impose normal sensations of posture and movements in which weightbearing exercises played an important role. Facilitation of postural activity by touch and proprioceptive stimuli for low or flaccid muscle tone. Resistive exercises, mass movements, and use of simple and abnormal reflexes were forbidden. Progress generally followed the normal developmental sequence. For Gr1 and Gr2, each treatment session lasted 3045 min.

Gr3: Standard N/A customary care: Gait training exercises performed in anatomical planes. Progression was encouraged either by gradual increase in number of joints involved or by increased resistance to a requested movement. Passive movements were administered to immobile joints. Option of using pulleys, suspensions, or weights. Practice of ADL training for independence began as early as possible. Each treatment session lasted 3045 min.

At least 5 Follow2, 0, 0 sessions/wk for ups at 2 6 wk wk (midtreatment), 4 wk (midtreatment), and 6 wk (end of treatment)

Appendix 3A 125

continues


126

Author and year Comparison group Gr1: 67.3 SD: 9.6 Gr2: 67.8 SD: 7.2 Gr1: Home-based exercise training provided by PT. 10min warm-up (stretching and flexibility); 4 blocks: 1) Assistive and resistive exercise using PNF patterns to upper and lower extremities or theraband exercises to major muscle groups of upper and lower extremities. Progression: When patient was able to complete 2x20 repetitions, increased theraband resistance or increased PNF manual resistance. 2) 15 min of balance exercises. 3) Patients encouraged to use affected upper extremity in functional activities. 4) Progressive walking program/exercise on a bicycle ergometer x 20 min. Gr2: Usual care as Concurrent prescribed by their treatment: Speech physicians (6 patients therapy if needed. had home health visits, 4 patients had outpatient physiotherapy). Visit included balance training, progressive resistive exercises, bimanual activities, and facilitative exercises. Gr1: 3 sessions/ None wk for 8 wk; 1.5 hr/session. Patients instructed to continue on their own for additional 4 wk. Gr2: Patients had approximately 39 visits, approximatively 44 min per visit. 2, 0, 1

Sample size





Duncan 1998103

Total: 20 Gr1: 10 Gr2: 10

Inclusion: Gr1: 66 days 3090 days after Gr2: 56 days onset, minimal or moderately impaired sensorimotor function, ambulatory with supervision and/or assistive device, living at home within 50 miles of the University of Kansas Medical Center. Exclusion: Medical condition that interfered with outcome assessment or limited participation in submaximal exercise program; Mini-Mental State score 16. Hemiplegia: Gr1: 18 R; 22 L Gr2: 22 R; 22 L

Gr1: 77.5 Gr1: 68.5 SD: 28.7 days SD: 9.0

Gr1: Exercise program: ROM and flexibility for shoulder, elbow, wrist, fingers, hip, ankle, and trunk. Strengthening resistive exercises, 2 sets of 10 repetitions, balance training, upper extremity functional use, endurance training (up to 30 min on bike), 36 sessions of 90 min.

Gr2: Standard N/A customary care: Home visits by research staff every 2 wk for health education, vital signs, and test of oxygen saturation.

1214 wk

N/A

2, 1, 1

Appendix 3A 127

continues


128

Author and year Comparison group Gr2: Same goaldirected, planar reaching tasks while moving against an opposing force generated by the robot. The magnitude of the opposing force was determined and modified according to patients muscle strength. Robotic therapy 1 hr, 3 x/wk for Follow-up delivered with 6 wk Gr2 at 6 wk the MIT-MANUS. Hemiparetic arm placed in a customized arm support and patient was asked to perform goaldirected, planar reaching tasks that emphasized shoulder and elbow movements while computer screen provided visual feedback. 55.5 SD: 17.2 Gr1: The robot provided movement assistance. 1, 0, 0

Sample size





Fasoli 2003105

Total: 20 Gr1: 13 Gr2: 7

Diagnosis of a 31 months single, unilateral SD: stroke within the 12.1 months past 1 to 5 yr verified by brain imaging; sufficient cognitive and language abilities to understand and follow instructions; and stroke-related impairments in muscle strength of the affected shoulder and elbow between grades 2 and 4 on the Medical Research Council (MRC) motor power score. Hemiplegia: 6 R; 14 L Treated area: Hemiplegic upper extremity 4075 Gr1: Exercise program: Gr2: Control: During the first week, patients Exercise program received 1 hr and 50 min without Kinetron. of therapeutic exercise and independently exercised for 10 min on the Kinetron. An additional 5 min of Kinetron was added weekly: 25 repetitions of both lower extremities was followed by rest for 1 min. Therapeutic 2 sessions/day, exercise program 5 days/wk for that consisted of 5 wk techniques based on neurophysiological and developmental theories.

Glasser 1986106

Total: 20 Gr1: 10 Gr2: 10

Inclusion: 36 months Patients who have hemiparesis due to stroke and who are 3 to 6 months onset. Hemiplegia: Gr1: 5 R; 5 L Gr2: 5 R; 5 L Treated area: Lower extremity

Follow-up 1, 0, 0 at end of treatment (5 wk)

Inaba 1973107 Total: 77 Gr1: 23 Gr2: 28 Gr3: 26 56 Gr1: 56.1 Gr2: 55.9 Gr3: 56.9 Gr1: Active exercise: Gr3: Control: No Consisted of bilateral hip and exercise treatment knee flexion and extension was given. in the supine and side lying positions; hip abduction and adduction; lower limb coordination exercises; and trunk flexion, extension, and rotation. Reciprocal exercise without resistance was accomplished by use of the Restorator for 15 min/day. Gr2: Progressive resistive exercise: Included mass extension of the involved lower limb in the supine position. Extension was initiated from 90 of knee flexion to full knee extension Functional training 4 to 8 wk and appropriate stretching was given if contracture that interfered with function was present. Functional training consisted of bed activities; assuming and maintaining sitting position; operating a wheelchair; transferring to and from bed, toilet, car, tub or shower; gait training on various surfaces; and getting up from the ground. Stretching was done for hip and knee flexion contractures. Follow-ups 1, 0, 1 at 1 month (end of treatment) and 2 months (end of treatment)

Hemiplegic patients 3 months or with CVA secondary less to thrombosis, embolus, or intracerebral hemorrhage; able to follow verbal or demonstrated directions; and able to push a 1.1 kg weight on the Elgin table with the involved lower extremity. Also unable to walk independently. Hemiplegia: Gr1: 8 L; 15 R Gr2: 14 L; 14 R Gr3: 13 L; 13 R Treated area: Lower extremity

Appendix 3A 129

continues


130

Author and year Comparison group Gr2: Control group: Regular therapy in rehab and 5 days/wk of group activity for general exercises. Regular therapy in rehab (physical therapy, OT, and speech therapy). Gr1: 8 wk; first 8 wk part lasted 5 (end of days/wk for 2 treatment) wk; second part lasted 3 x/wk for 30 min Gr1, 2: 63 SD: 11 Gr1: Aerobic exercise training: Trained on lower extremity cycle ergometer with individualized exercise program (on the basis of initial stress test results). Training divided into 2 parts: first part lasted 5 days/wk for 2 wk: started with multiple 2-min intervals, according to patient tolerance, with 1-min resting period (up to 10 min of work in first day). Add 1 min to one or more interval working periods each day so that by end of second wk could work continuously for 20 min at low level. Second part lasted next 6 wk: exercised 3 x/wk for 30 min. Intensity was limited to 60 % of heart rate reserve. 2, 0, 1

Sample size





Katz-Leurer 2003a108

Total: 90 Gr1: 46 Gr2: 44

Patients who were Subacute hospitalized up stage to 48 hr after the initiation of clinical signs of their first stroke. Hemiplegia: N/A

Katz-Leurer 2003b109 Gr2: 65 SD: 11

Total: 90 Gr1: 46 Gr2: 44

Patients who were Subacute hospitalized up stage to 48 hr after the initiation of clinical signs of their first stroke. Hemiplegia: N/A

Gr1: 62 SD: 11

Gr1: Exercise-training: Gr2: Control group: Trained on lower extremity No individualized cycle ergometer with exercise program. individualized exercise program (on the basis of initial stress test results). Training divided into 2 parts: First part: lasted 5 days/wk for 2 wk: started with multiple 2-min intervals, according to patient tolerance, with 1-min resting period (up to 10 min of work in first day). Added 1 min to one or more interval working periods each day so that by end of second wk patient could work continuously for 20 min at low level. Second part: lasted next 6 wk: exercised 3 x/wk for 30 min. Intensity was limited to 60 % of heart rate reserve.

N/A

Gr1: 8 wk; first part lasted 5 days/wk for 2 wk; second part: 30-min sessions,3 x/wk

Follow-up at 8 wk (end of treatment)

2, 0, 1

Appendix 3A 131

continues


132

Author and year Comparison group Three 45-min Follow-up sessions/wk for at 6 wk 6 wk (end of treatment) Gr1: 4.9 SD: 3.3 yr Gr2: 3.2 SD: 1.2 yr Gr2: 61.9 SD: 7.5 Gr1: 60.4 SD: 9.5 Gr1: Isokinetic strengthening: 5 min warm-up (5 repetitions of active alternative flexion and extension of the hip, knee, and ankle sitting in a chair followed by 5 min mild stretching of the paretic upper extremity) and 5 min cool down (mild stretching). 3 sets of 10 repetitions of maximal effort concentric hip flexion/extension, knee flexion/extension, and ankle dorsiflexion/plantiflexion were performed using Kin-Com Isokinetic Dynamometer for approximately 30 min. Rest break if necessary. Gr2: Control: Same N/A warm-up and cool down. 3 sets of passive ROM were performed for each joint of paretic lower extremity using Kin-Com Isokinetic Dynamometer. Participants were instructed to relax the extremity as it was moved into flexion and extension by the dynamometer. 2, 2, 1

Sample size





Kim 2001110

Total: 20 Gr1: 10 Gr2: 10

Patients aged 50 yr or more; history of a single stroke at least 6 months before participating in the study; ability to walk independently for a minimum of 40 meters with rest intervals, with or without assistive device; achievement of a minimum of stage 3 for leg and foot on the Chedoke-McMaster Stroke Assessment; activity tolerance of 45 min with rest intervals; and non-participation in any formal therapy program. Hemiplegia: Gr1: 6 L; 4 R Gr2: 2 L; 8 R

Kumar 1990111

Total: 28 Gr1: 12 Gr2: 8 Gr3: 8

Patients who had had a stroke recently. Hemiplegia: 12 L; 16 R Treated area: Shoulder

14.5 64.9 SD: 2.52 days SD: 18.2 Range, Gr1: 14.5 4390 SD: 1.51 days Gr1: 63.2 Gr2: 15.1 SD: 3.4 days Gr2: 70.1 Gr3: 13.8 Gr3: 60.8 SD: 2.36 days

Gr1: Overhead pulley exercise: Patients were seated in wheelchair between the pulley ropes. The upper extremity was positioned in 45 of abduction and was attached to one end of the rope with a mitten. The patient pulled the other end of the ropes and moved the arm through a range of 130150 of abduction always parallel to the scapula. Gr2: Skateboard: Patients were seated at a 32-in. high table. A skateboard with a figure eight on it was centered in front of the patient who was instructed to follow the figure eight with the affected arm. The arm was moved through approximately 90 of forward flexion, 90 of abduction, and 45 of adduction. Gr1: Motor relearning program: No specification. Gr2: Bobath: No specification. Treatments for both groups given for at least 40 min/session. Comprehensive, multi-disciplinary treatment for stroke from doctors, nurses, OTs, and speech therapists. 1 session/day, 5 days/wk until discharge (followed by out patient treatments). Followups at 2 wk (midtreatment) and 3 months (end of treatment) Gr2: Bobath: No specification. Treatments for both groups given for at least 40 min/session. Comprehensive, multi-disciplinary treatment for stroke from doctors, nurses, OTs, and speech therapists. 1 session/day, 5 days/wk until discharge (followed by out patient treatments) 1, 2, 1

Gr3: Passive ROM: Gait and ADL An OT passively training ranged the patients affected arm. The OT supported the patients elbow and forearm with one hand, and upper arm with the other. The shoulder was ranged 140150 of abduction. Care was taken to keep the upper extremity in external rotation during abduction. The shoulder was ranged of external and internal rotation. Elbow, wrist, and fingers were also ranged through full range of extension and flexion.

5 sessions/wk

N/A

1, 0, 1

Langhammer Total: 24 2000112 Gr1: 53 Gr2: 29

Patients with first-ever stroke with hemiparesis, verified clinically and by CT scan. Hemiplegia: Gr1: 16 L; 17 R Gr2: 11 L;17 R Gr1: Motor relearning program: No specification.

Not specified 78 SD: 9 Range, 4995

Langhammer Total: 28 2003113 Gr1: 27 Gr2: 21

Patients who agreed Not specified 78 to participate in the first study were invited to participate in a follow-up study.

Follow-ups 1, 0, 1 at 1 year and 4 yr

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Author and year Comparison group N/A Gr1: 12.3 days SD: 5.3 days Gr2: 72.7 Gr2: SD: 9.4 15.4 days SD: 12.2 days Gr1: 71.0 SD: 6.0 Mental imagery program: Patients were trained in the technique of mental imagery to practice specific tasks. In the first wk, the focus was on analyzing task sequences to facilitate motor planning and problem identification process using computer-generated pictures and movies. In the second wk, patients identified their own problems for rectification through the use of mental imagery. In the third wk, the focus was on practicing the rectified task perfomance using mental imagery and actual practice. In the functional retraining program, the demonstrationthen-practice method was adopted. Patient were required to practice the same tasks following a sequence and training schedule similar to that of the mental imagery program. However, the problems encountered by patients were rectified with the help of therapists. Patients in both 3 wk with five groups were trained 1-hr sessions to perform 3 sets each week of daily tasks. There were 5 tasks in each set including mobility functioning, balance, or upper limb coordination. The difficulty level was organized in ascending order, with the easiest tasks covered in the 1st wk. Patients in both groups also received 1hr physiotherapy sessions for training in walking and general muscle strengthening 5 days/wk. 2, 0, 1

Sample size





Liu 2004114

Total: 46 Gr1: 26 Gr2: 20

1) Diagnosed as having had a first unilateral cerebral infarction as confirmed by a CT scan; 2) age 60 yr or older; 3) independent in performing daily activities before admission; 4) able to communicate effectively, as screened by the Cognistat, and; 5) having given their voluntary consent.

Logigian 1983115

Total: 42 Gr1: 21 Gr2: 21

Patients with stroke 7 wk or less documented by CT scan within 7 wk of onset. Medically stable and fit to participate in a nonrestrictive program as determined by the attending physician.

Total: 61.6 SD: 21

Facilitation technique: Treatment included bilateral weight-bearing and weightshifting exercises; utilization of reflex inhibiting patterns; and tactile, vibratory, and vestibular stimulation activities.

Standard customary care emphasized strengthening the developing motion and maintaining full passive motion. Treatment techniques included passive, assistive, active, and progressive resistance exercises and employed the use of upper limb skateboard, weighted sanders, reciprocal pulleys, and springs. Each patient received between 60 to 90 min of treatment a day.

Physiotherapy Daily until N/A and OT exercises discharge (time in addition to not specified) ADL and speech therapy. Extra ROM exercises if patients wished.

1, 0, 0

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Author and year Comparison group Time since stroke onset, months: Gr1: 30.2 SD: 6.2 Gr2: 65.9 SD: 2.4 Gr2: 28.8 SD: 6.3 Gr1: 63.2 SD: 3.6 Gr1: Patient seated in a wheelchair, torso movement limited, affected limb strapped to forearm splint, robot manipulator attached to the splint. 4 exercise modes: 1) Passive: Robot moved arm toward target. 2) Active-assisted: Patient triggered initiation of movement with volitional force toward the target and worked with the robot as it moved the extremity. 3) Active-constrained: Robot provided viscous resistance in the direction of the desired movement and springlike forces in all other directions as the patient attempted to reach toward the target with maximal effort. 4) Bimanual: Patient attempted a bimanual mirrorimage movement while robotassisted affected extremity. Emphasis placed on target reaching movement, starting close to the body and ending further away. 4 point-to-point reaching directions trained: 1) forward medial, 2) directly forward, 3) forward lateral, 4) directly lateral. 12 targets located at shoulder or eye level. Progression from easiest exercise mode to most challenging. Gr2: Conventional treatment based on neurodevelopmental therapy: 10 min establishing physical postural base of support coupled with assessing and facilitating the alignment of the shoulder; and 35 min graded application of the arms use in ADLs. Emphasis on reeducation of muscles using sensorimotor approach to control motor output. 5-min exposure to robot. Concurrent treatment: Homebased exercise regimen or community-based stroke programs they were enrolled in at the time of intake into the study. 1 hr per session Follow-up 2, 2, 1 for 24 sessions at 6 months

Sample size





Lum 2002116 Total: 27 Gr1: 12M/ 1F Gr2: 8M/6F

Inclusion: Diagnosis of a single CVA, more than 6 months post-CVA, and obvious deficit in upper-extremity motor function as a result of CVA. Exclusion: Upper extremity joint pain or ROM limitations that would limit their ability to complete the protocols; unstable cardiovascular/ orthopedic/ neurologic conditions; and unable to cooperate with the study tasks. Hemiplegia: Gr1: 9 L; 4 R Gr2: 10 L; 4 R

Marigold 2005117 Gr2: 3.6 SD: 1.8 yr Gr2: 68.1 SD: 9.0

Total: 48 Gr1: 26 Gr2: 22

Patients aged 50 yr or more; single stroke; at least 12 months from onset; and able to walk with or without an assistive device for a minimum of 10 meters and have an activity tolerance of 60 min with rest intervals.

Gr1: 3.8 SD: 2.4 yr

Gr1: 67.5 SD: 7.2

5-min warm up: walking and light stretching and 5-min cool down: light stretching. Slow low-impact movements consisting of stretching and weight shifting. Weight shifting: Tai chi-like movements and reaching tasks. Stretching: Major muscle groups while standing and while on floor mats.

Same warm up and N/A cool down as Gr1. Challenged dynamic balance and tasks were progressively increased in difficulty. Emphasis on agility and multisensory approach. Tasks included standing in various postures and walking with various challenges. Additional exercises: sit-tostand movements, rapid knee raise while standing, and standing perturbations. Eyes closed conditions and foam surfaces were incorporated. Same as Gr1 except no external resistance. Standard customary 30 min/session, Follow-up 2, 0, 1 care. 3 x/wk at 8 months

1 hr/session, 3 Follow-up x/wk for 10 wk at 1 month

2, 0, 1

Moreland 2003118 Gr2: 38.1 Gr2: 72.0 SD: 25.6 days SD: 12.1

Total: 133 Gr1: 68 Gr2: 65

Patients who were less than 6 months post stroke; able to understand and follow instructions; motor recovery of the upper extremity at stages 3, 4, or 5, as defined by the CMSA stages; motor recovery of the foot at stages 2, 3, 4, 5 or 6; and informed consent given by the participant or substitute decision maker.

Gr1: 36.8 Gr1: 69.1 SD: 27.8 days SD: 14.8

Progressive resistance exercises with weight at waist or on lower extremities in functional patterns of movement.

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Author and year Comparison group Gr3: Bobath-trained N/A staff physiotherapists focused on increasing trunk and pelvic ROM, normalizing trunk muscle tone, maintaining appropriate balance responses during reaching, and improving the patients ability to move in and out of asymmetric posture; verbal and manual facilitation by therapist during seated reaching or lying. Gr4: Control: Standard customary care in physiotherapy and OT. 2 wk of daily training sessions Within 26 wk 72.4 SD: 9.01 Gr1: Portable computer-like BPM feedback console used to provide awareness of weight distribution during training in sitting; patient required to touch target with unaffected hand at various heights and distances and patients attempted to return to symmetrical position after reaching; 2 wk of training; 30 min session. Gr2: Task-related reach training: Patient seated on adjustable plinth, grocery items at about 140% of upper extremity length were retrieved with unaffected upper extremity and placed on shelves at various heights and distances to allow reaching to extremes of seated base of support. Follow-ups 2, 2, 1 at 2 and 12 wk

Sample size





Mudie 2002119

Total: 40 Gr1: 10 Gr2: 10 Gr3: 10 Gr4: 10

Patients had suffered a recent stroke and consistently bore majority of weight on one side.

Paul 1998120 Total: 20 Gr1: 10 Gr2: 10 Gr1: Music-making activity with upper extremity movement; participants had to find a rhythm or beat that was expressive and comfortable for them. Gr2: Physical exercise N/A group conducted by recreation therapists. Patients were encouraged to move their extremities in various directions and positions and to raise their affected extremities as high as they could in different directions (involved shoulder flexion and elbow extension). 30 min/session, Follow-ups 1, 0, 0 2 x/wk at 10 wk

Diagnosis of 93.4 days 61.75 unilateral cerebral SD: 49.5 days SD: 5.1 hemiplegia; had reached their maximum capacity of physical function and subsequently discharged from occupational and PT; had sufficient verbal comprehension to participate in the study, evaluated by the ability to follow 2- to 3step directions; had at least 10 of limitation in active shoulder flexion and elbow extension in the involved upper extremity; had at least stage IV Brunnstrom motor recovery in the affected upper extremity; were able to hold a drumstick that is 5 cm in diameter and weighed 8 grams in their affected hand; and free from cardiac conditions. Hemiplegia: 12 R; 8 L

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Author and year Comparison group Gr2: Control: Given N/A passive exercise for ROM to body joints in a systematic procedure for 30 min. 3 sessions/wk for 10 wk Follow-up at 10 wk (end of treatment) Range, 4372 yr Gr1: Exercise: Exercised on an adapted cycle ergometer for 30 min. During first 4 wk, training load was gradually increased from a workload representing 30%50% of maximal effort to the highest level attainable by the patient. The highest load was then maintained for the final 6 wk of training. 1, 0, 1

Sample size




Potempa 1995121

Total: 42 Gr1: 19 Gr2: 23

Patients who More than 6 had had a stroke months more than 6 months before randomization. Medically stable and had completed a formal rehab program. Hemiplegia: Gr1: 8 L; 11 R Gr2: 15 L; 8 R Gr1: 27 months SD: 12.7 months Gr2: 52.5 SD: 14.4 Gr2: 27.3 months SD: 11.4 months Gr1: 53.3 SD: 16.4 All patients received 6 wk of robot-aided exercises. All evaluation and training exercises consisted of reaching tasks in the horizontal plane that involved shoulder and elbow movements. Patients were asked to move between a center target and 8 peripheral targets arranged in circular display. 60 reps of each round of moving to the set of target were performed. Gr1: During resistance training, the robot provided resistance to the movement of reaching. Gr2: During active- N/A assisted training, the robot provided assistance in reaching each target if the patient was unable to reach independently. 3/wk for 1 hr N/A sessions, for a total of 18 hr of robot-aided exercise training per patient


Stein 2004122 Total: 18 Gr1: 9 Gr2: 9

Patient who had had a single previous stroke, residual paresis with average strength in the upper limb (measured at shoulder and elbow flexors and extensors) between 2 and 4 on the Medical Research Council grading system. All the patients were required to have conclued any conventional physical or OT before enrollment in the study. Hemiplegia: Gr1: 4 L; 5 R Gr2: 6 L; 3 R

2, 0, 1

TeixeiraSalmela 1999123 Gr2: 6.4 SD: 6.2 yr Gr2: 69.42 SD: 8.85

Total: 13 Gr1: 6 Gr2: 7

Patients with unilateral stroke with residual weakness, spasticity, or both, of the affected lower extremity. At least 9 months post stroke; independently ambulatory for 15 min with or without assistive devices; with an activity tolerance of 45 min with rests; and no comprehensive aphasia. Hemiplegia: Gr1: 3 L; 3 R Gr2: 4 L; 3 R

Gr1: 9.15 SD: 12.7 yr

Gr1: 65.87 SD: 10.16

Gr1: Exercise: Supervised Gr2: Control: No sessions included a warm exercise treatment up (510 min) co

stroke practice guideline

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