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

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Weighted brace Behavioral
    Intervention Desc: People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months
    ARM 1: Kind: Experimental
    Label: Weighted brace
  • Non weighted brace Behavioral
    Intervention Desc: People will be given a brace with no weight they will have to wear all the day during three months.
    ARM 1: Kind: Experimental
    Label: non weighted brace

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Six minutes walking test 3 months after the inclusion No

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