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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation robotics | Experimental | Subjects will be practicing an Armeo Spring rehabilitation program in addition to their usual care (1.5h/day,5d/week) 1h/day 5d/week 4 weeks. |
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| Self-rehabilitation | Active Comparator | Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation. |
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| Healthy volunteer | Other | 20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARMEO Spring | Device | Use of the device 1 hour per day, 5 days per week during 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer upper limb motor score | Increase of the Fugl Meyer score between day 0 and day 30 with a difference between groups by at least 4 points | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Costs | The rehabilitation costs will be assessed for each group through medical and physiotherapist consultations, hospitalization costs, day of return to work if concerned. | One year |
| Stroke impact scale (SIS) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier REMY-NERIS, Professor | University Hospital, Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens | Amiens | 80000 | France | |||
| CRRRF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38812037 | Derived | Cornec G, Lempereur M, Mensah-Gourmel J, Robertson J, Miramand L, Medee B, Bellaiche S, Gross R, Gracies JM, Remy-Neris O, Bayle N. Measurement properties of movement smoothness metrics for upper limb reaching movements in people with moderate to severe subacute stroke. J Neuroeng Rehabil. 2024 May 29;21(1):90. doi: 10.1186/s12984-024-01382-1. | |
| 33910364 |
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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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| Self rehabilitation | Other | Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks. |
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The quality of life will be assessed through the SIS.
| One year |
| Visual analog scale (VAS) | The pain of the shoulder and the upper limb will be assessed in different positions | Day 7,14,21,30, 90,180, 360 |
| Modification of motor control | Parameter and result of rehabilitation program on ARMEO spring are saved. Data of patient in rehabilitation robotics and healthy volunteer arms will be compared in order to evaluate the modification of the motor control at Day 30. | Day 30 |
| Angers |
| 49000 |
| France |
| CHU de Bordeaux | Bordeaux | 33073 | France |
| CHRU de Brest | Brest | 29609 | France |
| Centre Bouffard Vercelli | Cervera de la Marenda | 66290 | France |
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63118 | France |
| CHU de Dijon | Dijon | 21079 | France |
| CH de Garches | Garches | 92380 | France |
| EMPR Le Normandy | Granville | 54000 | France |
| CHU de Nîmes | Le Grau-du-Roi | 30029 | France |
| CHRU de Lille | Lille | 59037 | France |
| CHU de Limoges | Limoges | 87042 | France |
| CHU de Lyon | Lyon | 69000 | France |
| CRF de Valmante | Marseille | 13275 | France |
| CHU de Montpellier | Montpellier | 34172 | France |
| IRR de Nancy | Nancy | 54690 | France |
| CHU de Nantes | Nantes | 44093 | France |
| APHP - Hôpital La Salpétriere | Paris | 75000 | France |
| APHP - Hôpital Lariboisière | Paris | 75000 | France |
| CMRRF Kerpape | Ploemeur | 56275 | France |
| CHU de Reims | Reims | 51100 | France |
| CHU de Rennes | Rennes | 35 033 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| Remy-Neris O, Le Jeannic A, Dion A, Medee B, Nowak E, Poiroux E, Durand-Zaleski I; REM Investigative Team*. Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial. Stroke. 2021 Jun;52(6):1938-1947. doi: 10.1161/STROKEAHA.120.032545. Epub 2021 Apr 29. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |