Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Six minutes walking test
Study Overview
Brief Summary
This study is designed to determine if adding daily weighted braces on the unaffected ankle may benefit to patient who have returned home compare to a placebo intervention (ankle brace without weight).
Detailed Description
Improve walking ability in people after stroke is a key objective for rehabilitation. Once the rehabilitation period is finished, a reduction of functional and motor abilities is often observed in subjects when they returned home.
This study will examine if loading daily the non paretic leg with additional weights will improve walking abilities. This study will enroll 100 people who had a stroke > three months and < five years and who still experienced difficulties for walking.
Each patient will receive 3 months of intervention targeting their non affected leg. Half of the subjects will have to wear braces with additional weights at the non affected ankle during the day ( > 6 hours), while the other half will wear a similar brace but without weight.
A six minutes walking test will be given before and after the intervention, as well six and twelve months later to measure the effect of these interventions. The investigators hypothesize that people receiving the additional weights to the non paretic leg will show greater improvements in their walk abilities.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hemiparesis following ischemic or hemorrhagic infarct of a single hemisphere
- •First episode of stroke experienced > 3 months and < 5 years prior to study enrolment
- •Functional Ambulation Categories (FAC) score > 3 < 8
- •Be able to walk few meters without physical assistance
- •Able to understand and follow instructions
Exclusion Criteria
- •Following inpatient physical rehabilitation
- •Experienced more than 2 falls during 3 months prior inclusion
- •Signs of bilateral impairments
- •Daily use of a wheelchair to move
- •Contra-indications for daily walk
- •Currently participating in any clinical trial with a experimental walking intervention
- •Severe arthrosis
Arms & Interventions
Weighted brace
Intervention: Weighted brace (Behavioral)
non weighted brace
Intervention: Non weighted brace (Behavioral)
Outcomes
Primary Outcomes
Six minutes walking test
Time Frame: 3 months after the inclusion
Total distance walked in meters (6MWD) within the 6 minutes.
Secondary Outcomes
- six minutes walking test(12 months after the inclusion)
- six minutes walking test(6 months after the inclusion)