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

NCT ID: NCT01366729

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-08-31

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

Conditions

Stroke Gait Rehabilitation

Keywords

hemiplegia; walking; canes; TheraTogs; EMG; balance; Timed up and go

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TheraTogs

Group Type: EXPERIMENTAL

TheraTogs

Intervention Type: DEVICE

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.

Cane walking

Group Type: ACTIVE_COMPARATOR

Cane walking

Intervention Type: DEVICE

All walking activities must take place with cane from waking until sleeping

Interventions

TheraTogs

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.

Intervention Type: DEVICE

Cane walking

All walking activities must take place with cane from waking until sleeping

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University

OTHER

Sponsor Role: collaborator

Technical University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Clare Maguire

Principal researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clare C Maguire, MSc PT

Role: PRINCIPAL_INVESTIGATOR

Technical University of Bern, Bildungszentrun Gesundheit, Basel-Stadt

Locations

RehaClinic Bad Zurzach

Bad Zurzach, Canton of Aargau, Switzerland

Felix Platterspital

Basel, Canton of Basel-City, Switzerland

Kantonsspital Luzern

Lucerne, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 22462692 (View on PubMed)

Other Identifiers

TTvS_13DPD6_134993_BFHBZG

Identifier Type: -

Identifier Source: org_study_id