title: 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.
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
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01366729.
authors.affiliation: Bildungszentrum Gesundheit Basel-Stadt & Bern University of Applied Science, Binningerstrasse 2, 4142, Muenchenstein Basel, Switzerland. clare.maguire@bzgbs.ch
authors.forename: Clare
authors.initials: C
authors.lastname: Maguire
authors.forename: Judith M
authors.initials: JM
authors.lastname: Sieben
authors.forename: Florian
authors.initials: F
authors.lastname: Erzer
authors.forename: Beat
authors.initials: B
authors.lastname: Goepfert
authors.forename: Matthias
authors.initials: M
authors.lastname: Frank
authors.forename: Georg
authors.initials: G
authors.lastname: Ferber
authors.forename: Melissa
authors.initials: M
authors.lastname: Jehn
authors.forename: Arno
authors.initials: A
authors.lastname: Schmidt-Trucksäss
authors.forename: Robert A
authors.initials: RA
authors.lastname: de Bie
mesh_terms: D000203:Activities of Daily Living; D001696:Biomechanical Phenomena; D002183:Canes; D002985:Clinical Protocols / Q000592:standards*; D004185:Disability Evaluation; D004576:Electromyography; D005684:Gait / Q000502:physiology*; D006801:Humans; D007702:Kinetocardiography; D008137:Longitudinal Studies / Q000592:standards; D009989:Orthotic Devices; D017063:Outcome Assessment, Health Care; D004856:Postural Balance / Q000502:physiology; D020127:Recovery of Function / Q000502:physiology*; D016037:Single-Blind Method; D012919:Social Behavior; D020521:Stroke / Q000503:physiopathology / Q000523:psychology; D000071939:Stroke Rehabilitation; D016138:Walking / Q000502:physiology