Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Behavioral: Weighted brace
* Behavioral: Non weighted brace


Participation Criteria
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Eligibility Criteria
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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 Dementia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weighted brace<br> | Behavioral: Weighted brace<br>* People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months<br>|
| Placebo Comparator: non weighted brace<br> | Behavioral: Non weighted brace<br>* People will be given a brace with no weight they will have to wear all the day during three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minutes walking test | Total distance walked in meters (6MWD) within the 6 minutes. | 3 months after the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six minutes walking test | Total distance walked in meters (6MWD) within the 6 minutes | 6 months after the inclusion | 
| six minutes walking test | Total distance walked in meters (6MWD) within the 6 minutes | 12 months after the inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistance training, Walking, Weight bearing