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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01049-32 | Other Identifier | IDRCB |
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difficulty of inclusion
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.
Hypothesis:
An intensive and active physiotherapy delivered as soon as D2 post stroke could induce faster motor control recovery and autonomy than could do an usual conservative treatment aiming at preventing complications. The benefits could be a shortened inpatient stay (both in stroke unit and rehabilitation centre), a reduction of the secondary complications with a cut in of the total cost of care.
Primary objective:
To compare two strategies of physiotherapy on the evolution of motor control recovery during the first 3 months post stroke.
Secondary objectives :
To compare two strategies of physiotherapy on:
Assessment criteria:
-First criterion : Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK between day 0 and month 3.-Secondary criteria :
Method:
This is a "Zelen", single-blinded, randomised, controlled, multicentric trial aiming at comparing intensive physiotherapy after a stroke with the usually more conservative physiotherapy provided. Treatment is applied from the inclusion to the end of the stroke unit stay or until D15 post stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1: standard physiotherapy | Placebo Comparator | daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day. |
|
| group 2: experimental physiotherapy | Experimental | physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard physiotherapy | Procedure | daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK | between day 0 and month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Motor control deficiency assessed by the FM scale | Motor control deficiency assessed by the FM scale on D15, D30, D45, M3 and by the time requested before being able to walk 10 meters without human assistance. | at D15, D30, D45, M3 |
| Total length of stay as inpatient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain YELNIK, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de MPR - Hôpital Fernand Widal | Paris | 75010 | France | |||
| Service de Neurologie - Hôpital Lariboisière |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28008092 | Result | Yelnik AP, Quintaine V, Andriantsifanetra C, Wannepain M, Reiner P, Marnef H, Evrard M, Meseguer E, Devailly JP, Lozano M, Lamy C, Colle F, Vicaut E; AMOBES Group. AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial. Stroke. 2017 Feb;48(2):400-405. doi: 10.1161/STROKEAHA.116.014803. Epub 2016 Dec 22. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| experimental physiotherapy | Procedure | physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day. |
|
Total length of stay as inpatient |
| up to D30 |
| Autonomy assessed by the Functional Independence Measure (motor subscale) | at D30 and M3 |
| Autonomy assessed by the Rankin scale | at D15, D30, D45, M3. |
| Unexpected events | Unexpected events recorded on D30 and M3 | at D30 and M3 |
| Quality of life assessed by the Stroke Impact Scale | Quality of life assessed by the Stroke Impact Scale on M3 | at M3 |
| Residency | at M3 |
| Scale PASS | Evaluation scale of balance PASS at D30 and M3 | at D30 and M3 |
| Paris |
| 75010 |
| France |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |