benefits of fes cycling & locomotortraining approaches after sci

Deborah Backus, PT, PhDAssociate Dir, SCI Research

Shepherd CenterAssistant ProfessorEmory University

Atlanta, GA

Benefits of FES Cycling & LocomotorTraining Approaches after

SCI

Academy Spinal Cord Injury ProfessionalsAnnual MeetingSeptember 2011

DisclosuresDeborah Backus, PT, PhD has no financial

interest or relationships to disclose

CME Staff DisclosuresProfessional Education Services Group staff and

planning committee have no financial interest or relationships to disclose.


Fact

People with SCI, as well as their caregivers and clinicians, are seeking

solutions to:

Increase function and recovery after SCI, as well as

Improve health and wellness


Potential Solutions?

Advances in neuroscience researchDevelopment of new technology

geared toward SCI Much focus on “activity-based” interventions and programs


Learning Objectives

Upon completion of this session, participants will:Define activity-based interventions and

discuss the relevance for improving neural activity and function, or health and wellness, in p with SCI;

Discuss the findings from relevant literature over the past 10 to 20 years related to the efficacy of activity-based interventions for improving health-related, neural and functional outcomes in p with spinal cord injury (SCI). Academy Spinal Cord Injury Professionals

Annual MeetingSeptember 2011

Activity-Based Interventions

Include any intervention focused on activating nerves, receptors & muscles below the level of injury rather than accommodating/compensating for the paralysis & sensory loss due to SCI by using the intact limbs only Functional electrical stimulation cycling (FES cycling)

Locomotor training (LT) approachesCompiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR

Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation6

Rationale for Use of ABint for Neural & Functional Benefits?

Evidence from animal models of SCI:Use of intense and repeated sensory

stimulation, and intense motor practice, or exercise, can elicit plasticity throughout the neural axis (Hutchinson et al 2004;Ying wt al. 2008;Gazula et al. 2004;Goldschmidt et al. 2008; McDonald et al, 2002; Perez et al 2004)

Evidence from other patient populations (eg. Stroke):Intense, focused, repeated active

movement of impaired limbs, especially when combined with sensory augmentation, is beneficial for improving function, and inducing neural changes in the cerebral cortex

FES cycling and LT can provide these required elements

Question #1

What is the evidence in humans with SCI that the

application of these principles will lead to neural changes and/or functional benefits?

What is required to improve health and wellness after SCI?Need to place a demand on the

cardiovascular, respiratory and musculoskeletal systems, generally using large muscle groups, BUT:The large muscles are generally the ones that

are paralyzed or weakPeople with SCI have diminished cardiac

responsesAutonomic dysregulation is a problem for most

people with tetraplegia or high paraplegiaBoth FES cycling and LT:

Activate large musclesPlace demand on the cardiovascular and

respiratory systems

Question #2

What is the evidence that the use of activity-based interventions in humans

with SCI will lead to health and wellness benefits?

Shepherd Center Systematic Review Group Leadership team: Lesley Hudson, MS; David Apple, MD;

Deborah Backus, PhD, PT Reviewers:

Jennith Bernstein, PTAmanda Gillot, PT Jennifer Huggins, OTAshley Kim, PTElizabeth Sasso, PTKristen Casperson, PTBrian Smith, PTAnna Berry, PTAngela Cooke, RN

Data coordinator: Rebecca Acevedo

Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant #

(H133A050006) at Boston University Center for Psychiatric Rehabilitation

Review conducted using a system for rating the rigor and meaning of disability research (Farkas, Rogers and Anthony, 2008). The first instrument in this system is: “Standards for Rating Program Evaluation, Policy or Survey Research, Pre-Post and Correlational Human Subjects” (Rogers, Farkas, Anthony & Kash, 2008) and “Standards for Rating the Meaning of Disability Research” (Farkas & Anthony, 2008).



Definitions

“Neural recovery” or “changes in neural function”:Measurable changes in neural circuitry or

neuronal activity at any level of the neural axis in response to injury or learning

“Functional ability”:Includes any skill that leads to improved

mobility (locomotion, bed mobility, transfers) or activities of daily living:

Definitions

“Exercise effects”:Include changes or modifications in

cardiorespiratory or vascular responses, metabolism, and muscle parameters (size, girth, volume, blood flow, metabolism)

“Health-related benefits”:Include markers related to cardiac

function and indicators of cardiac disease, and metabolic function and indicators of diabetes or other metabolic instability or diseaseCompiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination &

Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Study Designs

Experimental: Employed methods including a random assignment and a control group or a reasonably constructed comparison group

Quasi-experimental: No random assignment, but either with a control group or a reasonably constructed comparison group

Descriptive: Neither a control group, nor randomization, is used. These included case studies and reports, studies employing repeated measures, and Pre-post designs.



FES Cycling Studies


(H133A050006) at Boston University Center for Psychiatric Rehabilitation1.16

Restorative Therapies, Baltimore, MD

ERGYS Muscle Power

Neural-related Benefits of FES Cycling

Only one of 17 articles reviewed for neural and functional effects of FES Cycling in people with SCI between 1989 and 2009 (Griffin et al. 2008)



Griffin et al. 2008

Evaluated the efficacy of FES cycling on ASIA sensory and motor scores (neural, no functional data)

18 adults with chronic paraplegia or tetraplegiaMajority classified with incomplete

injuries (n=13)Remainder classified as complete

The method for determining these classifications was not provided

Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR


Outcome Measures & Training (Griffin et al 2008)

ASIA assessed before and after a 10-week intervention

Training 2 to 3 times/week for 10 weeks on FES cycle in an inpatient hospital

Stimulation frequency for the FES cycle = 50 Hz

Maximal stimulation intensity = 140 mA, Adjusted to maintain a cadence of 49 rpm

Resistance was only increased by 1 kp after subject was able to cycle for three consecutive sessions for 30 minutes without interruption



Neural Outcomes (Griffin et al. 2008)

Significant improvements in ASIA LEMS scores & sensory scores

Improvements coincided with increases in cycling power over the duration of the intervention period

Suggest that the FES cycle might be a viable alternative for improving motor function in the lower extremities for individuals with incomplete SCI

BUT requires much more study



Health-related Benefits of FES Cycling

10 papers report on cardiorespiratory, pulmonary, metabolic, muscle or vascular effects of FES Cycling in people with SCI between 1989 and 2009Experimental approach n=2Quasi-experimental approach n=1Descriptive n=7



Summary: Participant Characteristics

n AIS Classification Level Acute/Chronic Sex Age

A B C /DTetr

aPara Acute Chronic M F

Arnold et al. 1992

12 11*** 0 1*** 7 53

months22 yrs 10 2 16-46

Bhambhani et al. 2000

14 X* X na 3 4 na 1-29 yrs 5 2 26-65

Demchak et al. 2005

10 8 2 na 5 5 X## Na 8 2 17-50

Faghri et al. 1992

13 5** 3** 5** 7 6 na 3-16 yrs 12 1 21-41

Fornusek & Davis 2008

9 9 na na 0 9 na 1-11 yrs 7 2 26-48

Hooker et al. 1992

18 11*** 4*** 3*** 10 86

months15 yrs 17 1 20-56

Johnston et al. 2007

4 4 na na 2 2 na 2-8 yrs 2 2 7, 9


30 22 6 2 11 19 na 1-12 yrs 17 135 to 13

Theisen et al. 2002

5 5 na na na 6 na2.9-8.1

yrs4 1 25-41

Zbogar et al. 2008

4 1 2 1 2 2 na2.5-16

yrs0 4 19-51

Summary: Outcome Measures

Outcome Measures

Cardio/Resp

Muscular MetabolicVascula

rOther

Arnold et al. 1992 X X X

Bhambhani et al. 2000

X X

Demchak et al. 2005

Xave weekly

power output

Faghri, Glaser, Faghri 1992

X

Fornusek & Davis et al. 2008

XPower output

Hooker et al. 1992 X XPower output


X X XLipid levels,

BMDJohnston et al. 2009

X XLipids,

cholesterol

Theisen et al. 2002 X XPower output

Zbogar et al. 2008 X

Representation of FES Cycling Parameters in RCT

Conditioning

CyclingOther info or

training

Device(s) used

Stim paramet

ersFreq

Duration

Demchak et al. 2005

30 reps of knee ext

with estim and 1 kg weight or able to

cycle with 2.4 watts

Began at 2 watts; 50rpm

Increased every 3, 30 min

sessions by 6.1 watts

Stimaster Clinical

Ergometry system

2 watts; max stim 140 mA

30 mins/da

y; 3

days/wk

13 weeks


Lower extremity stretching

prior to cycling

At home; 50rpm

RT300-P (FES) or RT100

(passive)

33Hz, 140mA

1 hour/da

y, 3X/wk

6 months

Results from RCTs (Demchak et al 2005 & Johnston et al. 2009)

Those who exercise with FES cycling demonstrated a non-significant 63% increase in muscle CSA after training (p=0.172), which was 171% greater than the CSA in persons in the SCI control group (p=0.05) (Demchak et al. 2005)

Children were safe using FES cyclingChildren who used FES had greater increases

in VO2 than those who used passive cycling (Johnston et al. 2009)



Other Findings from FES Cycling Studies

All people with acute or chronic SCI were able to increase time and resistance with FES cycling (Faghri et al. 1992; Hooker et al. 1992)

Participants all demonstrated an acute exercise response (Faghri et al. 1992; Bhambhani et al 2000)

Increase in small artery compliance by 63% (p=0.05) (Zbogar et al. 2008)

Muscle oxygenation responses were quite different from able-bodied participants (Bhambani et al. 2000)

Exercising at different cadences did not appear to affect cardiorespiratory or muscle oxygenation outcomes (Fornusek et al. 2008)Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge

Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for

Psychiatric Rehabilitation

Other Findings from FES Cycling StudiesPeople with tetraplegia do not respond the

same as those with paraplegia (cardiorespiratory and vascular responses)People with tetraplegia may have more autonomic

disruptionExercise programs designed for people with

tetraplegia may need to be different from those with paraplegia

Passive cycling may lead to cardiorespiratory benefits in some people with SCIRequires careful comparison between passive and

FES cycling in people with SCICost/value

Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder

Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Summary: FES Cycling Studies

Methodological ConsiderationsEach study addressed different health-related

problems in people with different levels, chronicity and completeness of SCIDifficult to draw conclusions for the general SCI population

Training duration was different for these studiesDemchak et al. -13 weeksJohnston et. al. - 6 monthsBhambhani et al. - a single testing sessionDifficult to know which training paradigm would lead to the

changes reported, and if another paradigm would lead to better or worse effects


Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Locomotor Training Studies


(H133A050006) at Boston University Center for Psychiatric Rehabilitation1.36

Neural & Functional Benefits of LT

Purpose: To evaluate all literature between 1998 and 2008 related to the efficacy for improving neural activity and function with the use of locomotor training (LT)

40 articles pulled from the literature and 21 articles met rigor and meaningfulness criteria:Experimental (n=3) Quasi-experimental (n=2)Descriptive (n=16)



Neural & Functional-related Benefits of LT

Humans with INcomplete SCI trained on treadmill with manual facilitation and assistance can improve gait and overground walking (Adams et al. 2006; Hicks et al. 2005; Hornby et al, 2005; Behrman AL & Harkema SJ, 2000; Wernig et al. 1995)



Health-related benefits of LT

n=8No reports of randomized controlled trials (RCT)

evaluating the exercise or health-related benefits of BWSTT in SCI

3 employed a control group in a quasi-experimental design, but no randomization

Remaining 5 used a descriptive study designUsed different approaches to BWSTT

BWSTTManual (M)Robotic (R)

BWSTT combined with neuromuscular electrical stimulation (NMES)39

Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University

Center for Psychiatric Rehabilitation

Summary of participant characteristics in

LT Studies

NAIS

Classification

LevelAcute/Chronic

Sex Age

A B C /D

Tetra

Para Acute Chronic

M F

Adams et al. 2006

1 X X X X 27

Carvalho & Cliquet 2005

21 X X X X X 24-40

Carvalho et al. 2005

31 X X X X X X 23-40

Carvalho, Zanchetta, Sereni, Cliquet 2005

31 X X X X X X 22-51

Ditor et al. 2005 6 X X X X X X X 19-57

Giangregorio et al. 2005

5 X X X X X X 19-40


14 X X X X X X 20-53

Israel et al. 2006 12 X X X X (1) X X 15-59

Summary of interventions & outcome measures in the LT

studiesType Freq Durati

onOutcome Measures

M R NMES

Cardio/

Resp

Muscular

Metabolic

Vascular

Adams et al. 2006

X 3x/wk 4 mos X

Carvalho & Cliquet 2005

2x/wk 6 mos X

Carvalho et al. 2005a

3X test only

X

Carvalho, Zanchetta, Sereni, Cliquet 2005

X X 1X test only

X

Ditor et al. 2005

X 3X/wk 4 mos X X


6-8 mos

X


X 12-15 mos

X

Israel et al. 2006

X 1X test only

X

Health-related Benefits of LT

Increased muscle mass acutely (Giangregorio et al. 2005), and chronically (Adams et al. 2006):Increases in muscle fiber area and in

type 1 fibers (Adams et al. 2006)Increased in femoral artery

compliance (Ditor et al. 2005)Increased VO2, VCO2, and energy

consumption (Carvalho et al. 2005, 2006)Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge

Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

48

Methodological Considerations LT Studies

The data varies based on the training paradigm, the participant characteristics (level, extent and chronicity of injury), and the outcome measures used

Studies employing similar participants training with identical programs, and receiving the same outcome measures will provide valuable insight related to the positive and negative health effects of BWSTT

Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Conclusions from Systematic Reviews

The evidence related to neural and functional effects suggests that only people with INcomplete SCI benefit from these approaches

There are health benefits following FES cycling or LT for people with either complete or incomplete SCIChanges in heart rate and blood pressure vary based on

level of injuryPeople with SCI who desire pursuing FES cycling or

LT should discuss which approach is best for them individually with their health care provider based on the level, extent and chronicity of their SCI.

NOT ONE SIZE FITS ALLCompiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge

Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Conclusions: Further Study Required to:Explore more fully the health-related effects of FES

cycling and LT Variable responses in arterial compliance and lipid profiles Impact on ANS

Compare FES cycling & LT in relation to the benefitsShould include cost-benefit analyses

Elucidate the differential responses/benefits to FES cycling & LT approaches for different levels, completeness and chronicity of SCI

Compare FES cycling, LT approaches and upper extremity exercise for their relative contributions to health-related benefits in SCI

Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/

NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation

Thank you!

National Institute on Disability and Rehabilitation Research

Shepherd Center Lesley Hudson, MS David Apple, MD Jennith Bernstein, PT Amanda Gillot, PT Ashley Kim, PT Elizabeth Sasso, PT Kristen Casperson, PT Brian Smith, PT Anna Berry, PT Angela Cooke, RN



benefits of fes cycling & locomotortraining approaches after sci

Documents

neural activity

neural functional benefits

level of injury

animal models of sci

efficacy of activity

neural axis hutchinson

repeated sensory stimulation

functional outcomes