Trials / Completed
CompletedNCT01952522
Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke
Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Weighted brace | People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months |
| BEHAVIORAL | Non weighted brace | People will be given a brace with no weight they will have to wear all the day during three months. |
Timeline
- Start date
- 2013-05-17
- Primary completion
- 2016-09-08
- Completion
- 2016-09-08
- First posted
- 2013-09-30
- Last updated
- 2025-09-15
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01952522. Inclusion in this directory is not an endorsement.