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

NCT01366729 | Terminated

• 1 other identifier: TTvS_13DPD6_134993_BFHBZG
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Timed "up and go" test

  the day after intervention completion (max 5 weeks)

Secondary Outcomes (7)

• surface EMG of hemiplegic lower extremity musculature

  the day after intervention completion (max 5 weeks)

• temporo-spatial gait parameters

  the day after intervention completion (max 5 weeks)

• hip kinematics

  the day after intervention completion (max 5 weeks)

• Dynamic balance

  the day after intervention completion (max 5 weeks)

• The Stroke Impact Scale

  the day after intervention completion (max 5 weeks)

Study Arms (2)

TheraTogs

EXPERIMENTAL

Device: TheraTogs

Cane walking

ACTIVE COMPARATOR

Device: Cane walking

Interventions

TheraTogs 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.

TheraTogs

Cane walking DEVICE

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

Cane walking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• orthopaedic or other neurological conditions that could limit walking ability
• no gross visuospatial or visual field deficits
• no medical contraindications to walking

Sponsors & Collaborators

• Technical University of Bern: lead
• Maastricht University: collaborator

Study Sites (3)

RehaClinic Bad Zurzach

Bad Zurzach, Canton of Aargau, Switzerland

Location

Felix Platterspital

Basel, Canton of Basel-City, 4012, Switzerland

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22462692 DERIVED

MeSH Terms

Conditions

Hemiplegia

Interventions

Canes

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Clare C Maguire, MSc PT

  Technical University of Bern, Bildungszentrun Gesundheit, Basel-Stadt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal researcher

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

CH (3)