Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial

Authors: Maijke van Bloemendaal, Sicco A. Bus, Charlotte E. de Boer, Frans Nollet, Alexander C. H. Geurts, Anita Beelen

Published in: Trials | Issue 1/2016

Login to get access

Abstract

Background

Many stroke survivors suffer from paresis of lower limb muscles, resulting in compensatory gait patterns characterised by asymmetries in spatial and temporal parameters and reduced walking capacity. Functional electrical stimulation has been used to improve walking capacity, but evidence is mostly limited to the orthotic effects of peroneal functional electrical stimulation in the chronic phase after stroke. The aim of this study is to investigate the therapeutic effects of up to 10 weeks of multi-channel functional electrical stimulation (MFES)-assisted gait training on the restoration of spatiotemporal gait symmetry and walking capacity in subacute stroke patients.

Methods

In a proof-of-principle study with a randomised controlled design, 40 adult patients with walking deficits who are admitted for inpatient rehabilitation within 31 days since the onset of stroke are randomised to either MFES-assisted gait training or conventional gait training. Gait training is delivered in 30-minute sessions each workday for up to 10 weeks. The step length symmetry ratio is the primary outcome. Blinded assessors conduct outcome assessments at baseline, every 2 weeks during the intervention period, immediately post intervention and at 3-month follow-up.

Discussion

This study aims to provide preliminary evidence for the feasibility and effectiveness of MFES-assisted gait rehabilitation early after stroke. Results will inform the design of a larger multi-centre trial.

Trial registration

This trial is registered at the Netherlands Trial Register (number NTR4762, registered 28 August 2014)
Appendix
Available only for authorised users
Literature
1.
Maeda A, Yuasa T, Nakamura K, Higuchi S, Motohashi Y. Physical performance tests after stroke: reliability and validity. Am J Phys Med Rehabil. 2000;79(6):519–25.CrossRefPubMed
2.
Langhammer B, Stanghelle JK, Lindmark B. Exercise and health-related quality of life during the first year following acute stroke. A randomized controlled trial. Brain Inj. 2008;22(2):135–45.CrossRefPubMed
3.
Wandel A, Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Prediction of walking function in stroke patients with initial lower extremity paralysis: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 2000;81(6):736–8.CrossRefPubMed
4.
Taub E. Somatosensory deafferentation research with monkeys: implications for rehabilitation medicine. In: Ince LP, editor. Behavioral Psychology in Rehabilitation Medicine: Clinical Applications. New York: Williams & Wilkins; 1980. p. 371–401.
5.
Lewek MD, Bradley CE, Wutzke CJ, Zinder SM. The relationship between spatiotemporal gait asymmetry and balance in individuals with chronic stroke. J Appl Biomech. 2014;30(1):31–6.CrossRefPubMed
6.
Chaitow L, DeLany JW. Clinical applications of neuromuscular techniques. Volume 2: the lower body. London: Churchill Livingstone; 2002.
7.
Awad LN, Palmer JA, Pohlig RT, Binder-Macleod SA, Reisman DS. Walking speed and step length asymmetry modify the energy cost of walking after stroke. Neurorehabil Neural Repair. 2015;29(5):416–23.CrossRefPubMed
8.
Franceschini M, Rampello A, Agosti M, Massucci M, Bovolenta F, Sale P. Walking performance: correlation between energy cost of walking and walking participation. New statistical approach concerning outcome measurement. PLoS One. 2013;8(2):e56669.CrossRefPubMedPubMedCentral
9.
Jørgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995;76(1):27–32.CrossRefPubMed
10.
Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, et al. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014;9(2):e87987.CrossRefPubMedPubMedCentral
11.
Dunning K, Black K, Harrison A, McBride K, Israel S. Neuroprosthesis peroneal functional electrical stimulation in the acute inpatient rehabilitation setting: a case series. Phys Ther. 2009;89(5):499–506.CrossRefPubMed
12.
Wilkinson IA, Burridge J, Strike P, Taylor P. A randomised controlled trial of integrated electrical stimulation and physiotherapy to improve mobility for people less than 6 months post stroke. Disabil Rehabil Assist Technol. 2015;10(6):468-74.
13.
Sabut SK, Sikdar C, Kumar R, Mahadevappa M. Improvement of gait & muscle strength with functional electrical stimulation in sub-acute & chronic stroke patients. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:2085–8.PubMed
14.
Morone G, Fusco A, Di Capua P, Coiro P, Pratesi L. Walking training with foot drop stimulator controlled by a tilt sensor to improve walking outcomes: a randomized controlled pilot study in patients with stroke in subacute phase. Stroke Res Treat. 2012;2012:523564.PubMedPubMedCentral
15.
Van Swigchem R, Vloothuis J, Den Boer J, Weerdesteyn V, Geurts A. Is transcutaneous peroneal stimulation benificial to patients with chronic stroke using an ankle-foot orthosis? A within-subject study of patients’ satisfaction, walking speed and physical activity level. J Rehabil Med. 2010;42:117–21.CrossRefPubMed
16.
Ring H, Treger I, Gruendlinger L, Hausdorff JM. Neuroprosthesis for footdrop compared with an ankle-foot orthosis: effects on postural control during walking. J Stroke Cerebrovasc Dis. 2009;18(1):41–7.CrossRefPubMed
17.
Van Swigchem R, Van Duijnhoven HJ, Den Boer J, Geurts AC, Weerdesteyn V. Effect of peroneal electrical stimulation versus an ankle-foot orthosis on obstacle avoidance ability in people with stroke-related foot drop. Phys Ther. 2012;92(3):398–406.CrossRefPubMed
18.
Sheffler LR, Hennessey MT, Naples GG, Chae J. Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation. Neurorehabil Neural Repair. 2006;20(3):355–60.CrossRefPubMed
19.
Kluding PM, Dunning K, O’Dell MW, Wu SS, Ginosian J, Feld J, et al. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke. 2013;44(6):1660–9.CrossRef
20.
Flansbjer U, Downham D, Lexell J. Knee muscle strength, gait performance, and perceived participation after stroke. Arch Phys Med Rehabil. 2006;87(7):974–80.CrossRefPubMed
21.
Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006;37(3):872–6.CrossRefPubMed
22.
Balasubramanian CK, Bowden MG, Neptune RR, Kautz SA. Relationship between step length asymmetry and walking performance in subjects with chronic hemiparesis. Arch Phys Med Rehabil. 2007;88(1):43–9.CrossRefPubMed
23.
Kojovic J, Djuric-Jovicic M, Dosen S, Popovic MB, Popovic DB. Sensor-driven four-channel stimulation of paretic leg: functional electrical walking therapy. J Neurosci Methods. 2009;181(1):100–5.CrossRefPubMed
24.
Tan Z, Liu H, Yan T, Jin D, He X, Zheng X, et al. The effectiveness of functional electrical stimulation based on a normal gait pattern on subjects with early stroke: a randomized controlled trial. Biomed Res Int. 2014;2014:545408.PubMedPubMedCentral
25.
Yan T, Hui-Chan CW, Li LS. 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(1):80–5.CrossRefPubMed
26.
Stroke - 1989. Recommendations on stroke prevention, diagnosis, and therapy. Report of the WHO Task Force on Stroke and other Cerebrovascular Disorders. Stroke. 1989;20(10):1407–31.CrossRef
27.
28.
Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002;16(3):232–40.CrossRefPubMed
29.
Connell LA, Tyson SF. Measures of sensation in neurological conditions: a systematic review. Clin Rehabil. 2012;26(1):68–80.CrossRefPubMed
30.
Gregson JM, Leathley MJ, Moore AP, Smith TL, Sharma AK, Watkins CL. Reliability of measurement of muscle tone and muscle power in stroke patients. Age Ageing. 2000;29(3):223–8.CrossRefPubMed
31.
Brashear A, Zafonte R, Corcoran M, Galvez-Jimenez N, Gracies JM, Gordon MF, et al. Inter- and intrarater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity. Arch Phys Med Rehabil. 2002;83(10):1349–54.CrossRefPubMed
32.
Perry J. Gait Analysis: Normal and Pathological Function. 1st ed. Thorofare: SLACK Incorporated; 1992.
33.
Van Bloemendaal M, Van de Water AT, Van de Port IG. Walking tests for stroke survivors: a systematic review of their measurement properties. Disabil Rehabil. 2012;34(26):2207–21.CrossRefPubMed
34.
Berg K, Wood-Dauphinee S, Williams JI. The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke. Scand J Rehabil Med. 1995;27(1):27–36.PubMed
35.
Mao HF, Hsueh IP, Tang PF, Sheu CF, Hsieh CL. Analysis and comparison of the psychometric properties of three balance measures for stroke patients. Stroke. 2002;33(4):1022–7.CrossRefPubMed
36.
Liaw LJ, Hsieh CL, Lo SK, Chen HM, Lee S, Lin JH. The relative and absolute reliability of two balance performance measures in chronic stroke patients. Disabil Rehabil. 2008;30(9):656–61.CrossRefPubMed
37.
Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005;34(6):614–9.CrossRefPubMed
Metadata
Title
Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial
Authors
Maijke van Bloemendaal
Sicco A. Bus
Charlotte E. de Boer
Frans Nollet
Alexander C. H. Geurts
Anita Beelen
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1604-x

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue

Research

Increased risk of type I errors in cluster randomised trials with small or medium numbers of clusters: a review, reanalysis, and simulation study

Study protocol

Progressive postresection program (pPRP) after pancreatic resection: study protocol for a randomized controlled trial

Study protocol

Effect of medication timing on anticoagulation stability in users of warfarin (the INRange RCT): study protocol for a randomized controlled trial

Study protocol

Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial

Study protocol

Pipelle for Pregnancy (PIP): study protocols for three randomised controlled trials

Study protocol

Walking adaptability therapy after stroke: study protocol for a randomized controlled trial