ANANTA: Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Weighted brace
|
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
|
| Placebo Comparator: non weighted brace
|
Behavioral: Non weighted brace
People will be given a brace with no weight they will have to wear all the day during three months.
|
Outcome Measures
Primary Outcome Measures
- Six minutes walking test [3 months after the inclusion]
Total distance walked in meters (6MWD) within the 6 minutes.
Secondary Outcome Measures
- six minutes walking test [6 months after the inclusion]
Total distance walked in meters (6MWD) within the 6 minutes
- six minutes walking test [12 months after the inclusion]
Total distance walked in meters (6MWD) within the 6 minutes
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sainte Anne Hospital | Paris | France | 75674 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- Centre Hospitalier Sainte Anne, Paris
- Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris
Investigators
- Study Director: Jean-Philippe Regnaux, PhD, French School of Public Health (EHESP)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P110702