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Open Access Highly Accessed Study protocol

How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids--canes and an orthosis TheraTogs--on the recovery of gait following acute stroke. A study protocol for a multi-centre, single blind, randomised control trial

Clare Maguire12*, Judith M Sieben3, Florian Erzer4, Beat Goepfert5, Matthias Frank6, Georg Ferber7, Melissa Jehn8, Arno Schmidt-Trucksäss8 and Robert A de Bie9

Author Affiliations

1 Bildungszentrum Gesundheit Basel-Stadt & Bern University of Applied Science, Binningerstrasse 2, 4142, Muenchenstein Basel, Switzerland

2 Caphri research school, Maastricht, the Netherlands

3 Department of Anatomy and Embryology, Caphri research school, Maastricht University, P.O. Box 616, 6200 MD Maastricht, the Netherlands

4 Rehab Basel, Im Burgfelderhof 40, 4012 Basel, Switzerland

5 Laboratory Of Biomechanics & Biocalorimetry, Biozentrum/Pharmazentrum, University of Basel, Klingelbergstrasse 50-70, 4056 Basel, Switzerland

6 Geriatric Competence Centre, Felix Platter Spital, Burgfelderstrasse 101, 4055 Basel, Switzerland

7 Statistik Georg Ferber GmbH, Cagliostrostrasse 14, 4125 Riehen, Switzerland

8 Department of Sports Medicine, Institute of Exercise and Health Science, University of Basel, Birsstrasse 320 B, 4052 Basel, Switzerland

9 Department of Epidemiology, Maastricht University, P.O. Box 616, 6200 MD Maastricht, the Netherlands

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BMC Neurology 2012, 12:18  doi:10.1186/1471-2377-12-18

Published: 30 March 2012

Abstract

Background

Annually, some 9000 people in Switzerland suffer a first time stroke. Of these 60% are left with moderate to severe walking disability. Evidence shows that rehabilitation techniques which emphasise activity of the hemiplegic side increase ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" (a corset with elasticated strapping) significantly increases hemiplegic muscle activity during gait. The aim of the present study is to investigate the long term effects on the recovery of gait, balance and social participation of gait rehabilitation with TheraTogs compared to gait rehabilitation with a cane following first time acute stroke.

Methods/Design

Multi-centre, single blind, randomised trial with 120 patients after first stroke. When subjects have reached Functional Ambulation Category 3 they will be randomly allocated into TheraTogs or cane group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardised procedure. Cane walking held at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with only the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented. The intervention will continue for five weeks or until patients have reached Functional Ambulation category 5. Outcome measures will be assessed the day before begin of intervention, the day after completion, 3 months, 6 months and 2 years. Primary outcome: Timed "up and go" test, secondary outcomes: peak surface EMG of gluteus maximus and gluteus medius, activation patterns of hemiplegic leg musculature, temporo-spatial gait parameters, hemiplegic hip kinematics in the frontal and sagittal planes, dynamic balance, daily activity measured by accelerometry, Stroke Impact Scale. Significance levels will be 5% with 95% CI's. IntentionToTreat analyses will be performed. Descriptive statistics will be presented.

Discussion

This study could have significant implications for the clinical practice of gait rehabilitation after stroke, particularly the effect and appropriate use of walking aids.

The results could be important for the development of clinical guidelines and for the socio-economic costs of post-stroke care

Trial registration number

ClinicalTrials.gov NCT01366729.