Gait Rehabilitation Post Stroke:the Long Term Effect of Two Walking Aids -Canes and TheraTogs

Study Overview
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Brief Summary
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Background 9000 people a year in Switzerland suffer a first time stroke. Of these 20 to 30% remain unable to walk and up to 60% are left with moderate to severe walking disability. Evidence shows that rehabilitation techniques which emphasise use of the hemiplegic side influence 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 ( elastic corset supporting hemiplegic side) significantly increases hemiplegic muscle activity during gait. To date no clinical studies have investigated the long term effects of these techniques on gait recovery following stroke. This study aims to determine if advances in the understanding of cortical plasticity and its relation to functional recovery following stroke can be applied to clinical gait rehabilitation to improve long term outcomes. Hypotheses Early gait rehabilitation with canes will reduce hemiplegic muscle activity and inhibit balance reactions. In the long term this causes poorer walking ability and balance and consequently reduced social participation. Early gait rehabilitation with TheraTogs will increase hemiplegic muscle activity and facilitate balance reactions. In the long term this improves walking ability and balance leading to increased social independence and participation. Design Multi-centred, single blind, randomized control trial. Subjects 120 first time stroke patients Intervention When subjects can walk unaided on even ground whilst requiring verbal prompts and stand-by help without body contact (FAC 3) they will be randomly allocated into intervention (TheraTogs) or control (cane) group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardized procedure. Cane walking with cane at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with 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 FAC 5 (independent walkers on all surfaces). Measures: the day before intervention begin, the day after intervention completion (max 5 weeks), 3 months, 6 months and 2 years after completion Primary outcome Timed up and go test Secondary outcomes surface EMG of hemiplegic lower extremity musculature, temporo-spatial gait parameters, hip kinematics, dynamic balance. The Stroke Impact Scale. Results Significance levels will be 5% with 95% CI's. ITT analyses will be performed. Descriptive statistics will be presented. Relevant co-variables will be identified and analysed. Discussion This study could have significant implications for the clinical practice of gait rehabilitation after stroke in particular the effect and appropriate use of walking aids

Official Title
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How to Improve Walking, Balance and Social Participation Following Stroke: a Comparison of Cane Walking to an Orthosis TheraTogs in Early Post-stroke Gait Rehabilitation. A Multi-centred, Single Blind,Randomized Control Trial.

Conditions
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Stroke Gait Rehabilitation

Intervention / Treatment
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* Device: TheraTogs
* Device: Cane walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with hemiplegia following a first unilateral stroke will score at least level 3 on the Functional Ambulation Category (FAC) (able to walk unaided on even ground but requiring verbal prompts and stand-by help without body contact) must have been independent walkers prior to insult without walking aids Subjects will have a Mini Mental State score of 22 or above Exclusion Criteria: orthopaedic or other neurological conditions that could limit walking ability no gross visuospatial or visual field deficits no medical contraindications to walking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TheraTogs<br> | Device: TheraTogs<br>* Orthosis facilitating hemiplegic hip extensor and abductor activity. Worn daily from dressing in the morning to undressing at night. May be removed during therapy or afternoon sleep.<br>|
| Active Comparator: Cane walking<br> | Device: Cane walking<br>* All walking activities must take place with cane from waking until sleeping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed up and go test |  | the day after intervention completion (max 5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surface EMG of hemiplegic lower extremity musculature | peak surface EMG of gluteus maximus and medius | the day after intervention completion (max 5 weeks) | 
| temporo-spatial gait parameters |  | the day after intervention completion (max 5 weeks) | 
| hip kinematics | hemiplegic hip kinematic measurements in sagital and frontal planes | the day after intervention completion (max 5 weeks) | 
| Dynamic balance | Sway Star | the day after intervention completion (max 5 weeks) | 
| The Stroke Impact Scale |  | the day after intervention completion (max 5 weeks) | 
| EMG activation patterns of hemiplegic leg musculature | EMG activation patterns of gluteus maximus, medius, vastus lateralis, semitendinosis, gastrocnemius and tibialis anterior | 1 day post intervention completion (max 5 weeks) | 
| Accelerometer Activity Monitoring | The accelerometer (Aipermon® GmbH, Germany) will be attached to the patient's belt and positioned above the left hip. Patients will wear the device during waking hours during intervention time. The accelerometer will be attached after dressing in the morning and only taken off for showering, bathing and sleeping. In the statistical analysis a day starts at 24.00 o'clock and ends at 23.59 o'clock the same day. Mean activity per day will be calculated | Immediately post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiplegia, walking, canes, TheraTogs, EMG, balance, Timed up and go