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| Name | Class |
|---|---|
| Centre Hospitalier Sainte Anne, Paris | UNKNOWN |
| Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weighted brace | Experimental |
| |
| non weighted brace | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weighted brace | Behavioral | People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Six minutes walking test | Total distance walked in meters (6MWD) within the 6 minutes. | 3 months after the inclusion |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Regnaux, PhD | French School of Public Health (EHESP) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sainte Anne Hospital | Paris | 75674 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Non weighted brace | Behavioral | People will be given a brace with no weight they will have to wear all the day during three months. |
|
| 12 months after the inclusion |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |