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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC/04-02 | Other Identifier | Rennes University Hospital |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone.
The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical gait repetitive training | Experimental | Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement |
|
| Conventional rehabilitation program | Active Comparator | Physiotherapeutic conventional rehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait trainer | Device | Mechanical gait repetitive training |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program | after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional ambulatory category | Days 0, 15, 28 and 90. | |
| Walking endurance (6 minute walk) | distance covered in a 6 minutes confortable walk | days 15, 28 and 90. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Régine Brissot, MD | Rennes University Hospital | Principal Investigator |
| Bruno Laviolle, MD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger | Aulnay-sous-Bois | 93602 | France | |||
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| Conventional rehabilitation |
| Device |
Physiotherapeutic conventional rehabilitation |
|
| Time to self sufficient gait recovery | Since inclusion Time |
| Spasticity (modified Ashworth score) | Days 0, 15, 28 and 90 |
| Motricity index | Days 0, 15, 28 and 90 |
| Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance) | Days 0, 15, 28 and 90 |
| Economic evaluation (healthcare requirements, rehabilitation unit length of stay) | At the end of the study |
| Centre du Docteur Bouffart-Vercelli |
| Cervera de la Marenda |
| 66290 |
| France |
| Centre de Rééducation de Coubert | Coubert | 77170 | France |
| Rééducation Fonctionnelle - Hôpital Raymond Poincaré | Garches | 92380 | France |
| Centre l'espoir | Hellemmes-Lille | 59260 | France |
| Centre Bretegnier | Héricourt | 70400 | France |
| Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol | Limoges | 87000 | France |
| Service de Médecine Physique et Réadaptation - Hôpital de l'Archet | Nice | 06202 | France |
| Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi | Nîmes | 30029 | France |
| Service de Rééducation Neuro-orthopédique - Hôpital Rothschild | Paris | 75012 | France |
| Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou | Rennes | 35033 | France |
| Centre de l'Arche | Saint-Saturnin | 72650 | France |
| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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