Stroke Gait Rehabilitation
Conditions
Keywords
hemiplegia, walking, canes, TheraTogs, EMG, balance, Timed up and go
Brief summary
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
Interventions
DEVICETheraTogs
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.
DEVICECane walking
All walking activities must take place with cane from waking until sleeping
Sponsors
Maastricht University
Technical University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timed up and go test | the day after intervention completion (max 5 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| temporo-spatial gait parameters | the day after intervention completion (max 5 weeks) | — |
| hip kinematics | the day after intervention completion (max 5 weeks) | hemiplegic hip kinematic measurements in sagital and frontal planes |
| Dynamic balance | the day after intervention completion (max 5 weeks) | Sway Star |
| surface EMG of hemiplegic lower extremity musculature | the day after intervention completion (max 5 weeks) | peak surface EMG of gluteus maximus and medius |
| EMG activation patterns of hemiplegic leg musculature | 1 day post intervention completion (max 5 weeks) | EMG activation patterns of gluteus maximus, medius, vastus lateralis, semitendinosis, gastrocnemius and tibialis anterior |
| Accelerometer Activity Monitoring | Immediately post intervention | 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 |
| The Stroke Impact Scale | the day after intervention completion (max 5 weeks) | — |
Countries
Switzerland
Outcome results
None listed