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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-A00747-46 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.
The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months. This will permit us 1) to assess the efficacy of continuing physical therapy sessions during the chronic phase of post-stroke hemiplegia, 2) to investigate whether the effects of physical therapy in these patients gradually decreases during the period of six months to two years post-stroke, and 3) to model the relationship between standard measures of gait performance (speed, endurance, balance, use of technical aids…) with other multidimensional covariates: social and environmental factors (type of housing, presence of a third person,…), cognitive factors (cognitive disorders associated) and thymic factors (anxiety, depression) and 4) to assess the costs associated with the physical therapy care of chronic-phase stroke patients .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | patients who continue physical therapy sessions during two months. |
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| 2 | No Intervention | patients who stop physical therapy sessions during two months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical therapy sessions | Behavioral | two physical therapy sessions per week for two months |
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| Measure | Description | Time Frame |
|---|---|---|
| the average number of steps per day recorded over 3 days in an outpatient setting | day 3 and then 6 months later |
| Measure | Description | Time Frame |
|---|---|---|
| the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score) | day 0 and then day 55 | |
| for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Giraux, MD | CHU ST Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Régional de Réeducation et de Réadaptation Fonctionnelle | Angers | 49103 | France | |||
| Groupe hospitalier Pellegrin CHU Bordeaux |
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| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| 6 months |
| Bordeaux |
| 33076 |
| France |
| Hôpital J. Rebeyrol | Limoges | 87042 | France |
| Institut Régional de médecine physique et de Réadaptation | Nancy | 54042 | France |
| CHU de St Etienne | Saint-Etienne | 42055 | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |