Clinical trial NCT01366729: Gait Rehabilitation Post Stroke:the Long Term Effect of Two Walking Aids -Canes and TheraTogs
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke Gait Rehabilitation
Keywords: hemiplegia
walking
canes
TheraTogs
EMG
balance
Timed up and go
Lead sponsor: Technical University of Bern
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2011-06-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Timed "up and go" test
timeFrame: the day after intervention completion (max 5 weeks)
Secondary outcomes:
measure: surface EMG of hemiplegic lower extremity musculature
timeFrame: the day after intervention completion (max 5 weeks)
measure: temporo-spatial gait parameters
timeFrame: the day after intervention completion (max 5 weeks)
measure: hip kinematics
timeFrame: the day after intervention completion (max 5 weeks)
measure: Dynamic balance
timeFrame: the day after intervention completion (max 5 weeks)
measure: The Stroke Impact Scale
timeFrame: the day after intervention completion (max 5 weeks)
measure: EMG activation patterns of hemiplegic leg musculature
timeFrame: 1 day post intervention completion (max 5 weeks)
measure: Accelerometer Activity Monitoring
timeFrame: Immediately post intervention
Other outcomes:
Locations:
city: Zurzach
country: Switzerland
facility: RehaClinic Bad Zurzach
state: Aargau
city: Basel
country: Switzerland
facility: Felix Platterspital
state: Basel-Stadt
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
affiliation: Technical University of Bern, Bildungszentrun Gesundheit, Basel-Stadt
name: Clare C Maguire, MSc PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maguire C, Sieben JM, Erzer F, Goepfert B, Frank M, Ferber G, Jehn M, Schmidt-Trucksass A, de Bie RA. 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. BMC Neurol. 2012 Mar 30;12:18. doi: 10.1186/1471-2377-12-18.