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Dr. Thorsten Böing Functional Electro Stimulation (FES) Clinical evidence and Study overview

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Page 1: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

Dr. Thorsten Böing

Functional Electro Stimulation (FES) Clinical evidence and

Study overview

Page 2: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

• Patients with foot drop disability after a damage of the CNS (Central Nervous System)

− Stroke

− Multiple Sclerosis (MS)

− TBI (Traumatic Brain Injury)

− SCI (Spinal Cord Injury)

− CP (Cerebral Palsy)

Functional Electro Stimulation (FES)

Indication

Page 3: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Lesion of CNS

good irritability with

electro stimulation

Lesion of PNS

poor irritability with

electro stimulation

General introduction electro stimulation

Possible applications

CNS

Lesion

Peripheral nerve

Stimulation

Muscle

CNS

Lesion

Peripheral nerve

Stimulation

Muscle

Page 4: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

• Transcutaneous Electronically Nerve-Stimulation (TENS)

– For pain therapy/treatment

• Therapeutically Electro Stimulation (TES)

– For therapeutic use ( f. ex. Stimulation current)

• Functional Electro Stimulation (FES)

– Stimulation of functional movement

– FES as therapeutic use

– For relearn movement patterns– Neuronal plasticitiy

Definition/ Terminology

General introduction electro stimulation

Page 5: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

FES vs. TENS

Differentiation

• Functional movement

• „Motor Re-Learning“ activation neurological pattern

• Physiological contraction of the muscles

• Higher triggering effect with training mode

• Pain reduction

• Muscle relaxing

• Better blood circulation

• No functional movement!

• No physiological muscle movement!

FES TENS

Page 6: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

The Nerves peroneus communes

innervation

− M. tibialis anterior

− M. extensor halluces longus

− M. extensor digitorum longus

Dorsal extension + Supination

− M. peroneus longus

− M. peroneus brevis

Plantarflexion + Pronation

Reference points

How does FES work?

Page 7: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Thermoplastic AFO vs. FES

Thanks toSH Klinz, Bernburg

Page 8: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

3D-Motion detection via

Gyroscope and accelerometer

Patient-AppL300 Go with more channel stimulation for

separate motion control of Dorsal

extension und Eversion

Short and intuitive

Set-Up

Integrated assessments: 10m-Walk test,

TOG

Main functions

Page 9: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Pediatric fitting L300 Go for small circumferences

Peroneus paresis Combined with knee

instability in anterior/posterior

f. ex. Genu recurvatum L300 Go + L300 Go

Upgrade

Selective Knee-instability or Quadriceps-insufficiency

L300 Go Stand alone

Peroneus paresis

L300 Go vs.

L100 Go

Clinical Differentiation

Page 10: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Time (Week)

Per

cent

age

of p

atie

nts

with

wal

king

abi

litie

s

0

10

20

30

40

50

60

70

80

90

0 2 4 6 8 10

84.6%

53.3%

46.2%

Yan T et al. Functional Electrical Stimulation improves motor recovery of the lower extremity and walking ability of subjects with first acute stroke. A randomized placebo-controlled trial. Stroke 2005; 36:80-85

FES and Standard-RehabilitationPlacebo and Standard-RehabilitationControlled (Standard-Rehabilitation)

Early as possible Intervention is successful

Page 11: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

0,00

0,20

0,40

0,60

0,80

1,00

1,20

Baseline One Month Two Months One Year

Sp

ee

d (m

/se

c.)

Improvement of walking speed

Laufer Y et al.: Gait in Individuals with Chronic Hemiparesis: One-Year Follow-up of the Effects of a Neuroprosthesis That Ameliorates Foot Drop. J Neurol Phys Ther, 2009. 33(2): p. 104-110.

0,67 0,70

0,86

1,06

Page 12: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Reduction of energy consumption

Burridge J et al.: The effects of common peroneal nerve stimulator on the effort and speed of walking: a randomized controlled clinical trial with chronic hemiplegic patients. Clin Rehabil 1997, 11:201-210.

0

5

10

15

20

25

30

perc

enta

ge im

prov

emen

t fro

m b

asel

ine

Follow-up 1(4-5 weeks later)

Follow-up 2(12-13 weeks later)

Speed PCISpeed PCI

control

FES(difference between follow-up assessment with stimulation and baseline assessment without stimulation)

5%

18%

6%

21%

5%

21%

5%

25%

Page 13: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

FES Improves Activity After Stroke

Howlett OA et al. Functional Electrical Stimulation Improves Activity After Stroke: A Systematic Review With Meta-Analysis. Arch phys med rehabil, 2015; 96(5):934-943

Page 14: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Long time FES-use with the indication MS

• Background: only a few studies looking over the longtime usability, results and

consequences. This study observed the orthopedic consequences in a Five-Year

Follow-up of a Longitudinal Cohort and examine the additional benefit of FES for the

Patient reported outcome; like f.ex. Pain in the joints.

• Method: 154 Patients, age ⌀ 59,8 (R: 28-74) initially measured 10m- walk-test,

visual analog scale (VAS) und Quality of life, after 6 month and than over 5 years,

each year (T0- T7)

• Results: Significant improvement of all measured parameters.

• Conclusion: Even despite progression of the MS long time users profitable

significantly of the FES

Street T et al. Five-Year Follow-up of a Longitudinal Cohort Study of the Effectiveness of Functional Electrical Stimulation for People with Multiple Sclerosis. Int J MS Care. 2018;20:224-230.

Page 15: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Orthopedic- therapeutic effect of FES used by MS patients

• Background: Systematic review and Meta analyze

• Method: Searching in the Data bank PubMed, CINAHL und ProQuest. Contents of the studies with therapeutic and/or orthopedic effects of FES evaluated with gait analyze.

• Results: All over significant orthopedic effects, mainly gait speed. Only 3 Studies looking also over the Carry-over (therapeutic effect; this is showing better gait abilities after the use of FES without any treatment), this was not significant! Conclusion: The most of the studies looking over one channel controlled FES systems, that does show; future studies should be prove the 2 channel systems as the solution with even a higher impact in Gait symmetry, speed and energy consumption.

Springer S et al. Effects of functional electrical stimulation on gait in people with multiple sclerosis - A systematic review. Mult Scler Relat Disord. 2017;13:4-12.

Page 16: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

• Multicentric (n = 23), international (DACH), consecutive Patient

recruiting from FES-responding patients

• Registration of 10 items each to the gait pattern (NeuroReha-Specialist:

PT, CPO, ) and to the ICF-based participation (Patient!)

• Time zone 08/13 - 05/15

• Cohort:

− n = 169 (cleaned up: n = 151), 67 women, 84 men

− ⌀ age 59,8 (R: 9 – 79)

− Effected since ⌀ 7,3 years (R: 1 – 33)

− CNS-relevant Diagnose (Stroke, MS, TBI, SCI)

Böing T. Hilfsmittelversorgungen bei Peronaeusparese im ICF-Fokus von Aktivität und Teilhabe. 3rd European Congress of NeuroRehabilitation, 2. Dezember 2015, Wien

AFO or FES?

ICF-based Examination

Page 17: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Disease

(Stroke, MS, TBI, SCI, CP)

Disease

(Stroke, MS, TBI, SCI, CP)

Body function and -structure

Body function and -structure

activitiesactivitiesPARTICIPATION PARTICIPATION

Environmental factorsEnvironmental factors Personal influenced factors

Personal influenced factors

Support of personal influenced factors:

mental social Networkmotivational social protection Coping-strategies economical situation

Support of environmental factors:

Possibilities of Rehabilitation and qualityCapability in profession and daily living Social norms

*International Classificationof Functioning, Disability, and Health. WHO 2001

ICF*

Page 18: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

FES during daily life

3,2

3,6 3,6

3,4

3,6

2,9

3,3

3,4 3,4

2,9

Ohne Hilfsmittel

No influence

gravedisability

Fulldisability

Böing T. Hilfsmittelversorgungen bei Peronaeusparese im ICF-Fokus von Aktivität und Teilhabe. 3rd European Congress of NeuroRehabilitation, 2. Dezember 2015, Wien

Without treatment

moderatedisability

lightdisability

Page 19: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

FES in daily life

3,2

3,6 3,6

3,4

3,6

2,9

3,3

3,4 3,4

2,9

2,0

2,32,4

2,2

2,6

1,9

2,22,3

2,4

2,1

Ohne Hilfsmittel

Mit Orthese

Böing T. Hilfsmittelversorgungen bei Peronaeusparese im ICF-Fokus von Aktivität und Teilhabe. 3rd European Congress of NeuroRehabilitation, 2. Dezember 2015, Wien

No influence

gravedisability

Fulldisability

moderatedisability

lightdisability

With FES treatment

FES during daily living is significantly better for the patient!

Why?

1. Higher Compliance

2. Higher acceptance to use a fitting

3. Significantly more participation!

Page 20: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Documentation

Page 21: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

• High grade of compatibility to neurophysiological

therapeutic technics, Vojta; PNF; Bobath

• Regulation of tone

• Daily living quality increased

• Full contact; also barefoot!

CP patient treatment FES

Pool D et al. Daily functional electrical stimulation during everyday walking activities improves performance and satisfaction in children with unilateral spastic cerebral palsy: a randomized controlled trial. Arch Physiother. 2015;5:5. Published online 2015 Jul 18. doi: 10.1186/s40945-015-0005-x

Bethoux F et al. Long-term follow-up to a randomized controlled trial comparing peroneal nerve functional electrical stimulation to an ankle foot orthosis for patients with chronic stroke. Neurorehabil Neural Repair. 2015;29(10):911-22

Postans NJ et al. Effect of functional electrical stimulation applied during walking, on gait in spastic cerebral palsy a small study of only eight children. Developmental Medicine & Child Neurology 2005,47:46–52

Kerr C et al. Electrical stimulation in cerebral palsy: a review of effects on strength and motor function. Dev Med Child Neurol. 2004;46(3):205-13.00472.x/full

Page 22: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Guidelines for differentiated use of FES

1

American Stroke Association – Clinical Practice Guideline (2010)2

3

Ottawa Panel – Clinical Practice Guidelines for Gait Training (2006)

40%

Increased Gait speed

15%

Increased balance(decreased risk of falling)

20%

Increased distance of walking

25%

Increased therapeutic effect

Gait symmetry and higher quality of life

Patient satisfaction and compliance

Increased

National Clinical Guidelines for Stroke, GB (2012)

4

Rehabilitation of mobility after stroke , S2e-Leitlinie der DGNR (2015)

1.O’Dell MW et al. Response and Prediction of Improvement in Gait Speed From Functional Electrical Stimulation in Persons With Poststroke Drop Foot. PM&R, 2014; 6(7):587-6012.Bethoux F et al. The Effects of Peroneal Nerve Functional Electrical Stimulation Versus Ankle-Foot Orthosis in Patients With Chronic Stroke: A Randomized Controlled Trial. Neurorehabil Neural

Repair, 2014; 28(7):688-6973.Kluding P et al. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke; 2013; 44(6):1660-16694.Everaert DG et al. Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial. Neurorehabil Neural Repair, 2013;

27(7):579-591 5.Dunning K et al. The Functional Ambulation: Standard Treatment versus Electrical Stimulation Therapy (FASTEST) trial for stroke: study design and protocol. Open Access Journal of Clinical

Trials, 2013; 5:39‐49. 6.Auchstaetter N. et al. Physical Therapists' Use of Functional Electrical Stimulation for Clients With Stroke: Frequency, Barriers, and Facilitators. Phys Ther, 2016; 96(7):995-10057.Howlett OA et al. Functional Electrical Stimulation Improves Activity After Stroke: A Systematic Review With Meta-Analysis. Arch phys med rehabil, 2015; 96(5):934-943 8.Teasell R et al. Evidence-Based Review of Stroke Rehabilitation - Mobility and the Lower Extremity; 2014, http://www.ebrsr.com/sites/default/files/Chapter%204A_Lower%20Extremity%20Post%

20Stroke.pdf

FES-Evidence: summary

excellent

Page 23: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

FES-treatment: Target and claim

• Optimal (not maximal!) treatment

• Constructive partnership of

Physician CPO

Therapist Patient

Payer

• Participation is the target for rehabilitation!

Page 24: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Page 25: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Page 26: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

T.Böing: Funktionelle Elektrostimulation - Klinische Evidenz und Überblick zur Studienlage | © Otto Bock HealthCare Deutschland

Steering Electrode

Quick Fit Electrode

Erweiterte Steuerung/Stimulation

Medial

Lateral

Page 27: Functional Electro Stimulation (FES) Clinical evidence and Study overview · 2019. 11. 14. · Speed PCI Speed PCI control FES (difference between follow-up assessment with stimulation

Thank you for your attention!

[email protected] (DACH)

[email protected] (Headquarter)