Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
238 participants
INTERVENTIONAL
2011-06-30
2017-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rehabilitation robotics
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.
ARMEO Spring
Use of the device 1 hour per day, 5 days per week during 4 weeks
Self-rehabilitation
Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation.
Self rehabilitation
Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.
Healthy volunteer
20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device.
ARMEO Spring
Use of the device 1 hour per day, 5 days per week during 4 weeks
Interventions
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ARMEO Spring
Use of the device 1 hour per day, 5 days per week during 4 weeks
Self rehabilitation
Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 18 to 80 years old
* stroke onset between 3 weeks to 3 months,with or without aphasia, with or without lateral neglect and homonymous hemianopia, with or without visual neglect
* 10\<or= Fugl Meyer upper limb Score \<or= 40
* upper limbs pain less or equal than 3/10 (VAS)
* inpatient or outpatient rehabilitation
* signed inform consent
Exclusion Criteria
* ischemic or hemorrhagic stroke of the brainstem
* major aphasia evaluated by a Boston Diagnostic Aphasia Examination (BDAE) score less or equal to 3
* asthenia not allowing to work 60 minutes with the robot.
* serious visual deficiency not allowing to use the robot
* impossibility to install the arm on the robot because of a serious and uncontrolled spasticity or for any other reason
* pronounced and constant muscular contractures, or deformation affecting the use of the extremity
* upper limb's pain superior to 3/10 and/or being worse at the active and passive mobilization
* serious infection and/or instability of vital functions
* perfusion of the affected upper limb not removable
* incapacity to stay on a chair
* contraindicated sitting position
* permanent deviation of the head and\\or of the eyes
* perturbed or non-cooperative patient
* patients that must have to be isolated due to an infection process
* bone fracture of the paretic limb with an onset less than 3 months stabilized or not
18 Years
80 Years
ALL
Yes
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Olivier REMY-NERIS, Professor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Brest
Locations
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CHU d'Amiens
Amiens, , France
CRRRF
Angers, , France
CHU de Bordeaux
Bordeaux, , France
CHRU de Brest
Brest, , France
Centre Bouffard Vercelli
Cervera de la Marenda, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CHU de Dijon
Dijon, , France
CH de Garches
Garches, , France
EMPR Le Normandy
Granville, , France
CHU de Nîmes
Le Grau-du-Roi, , France
CHRU de Lille
Lille, , France
CHU de Limoges
Limoges, , France
CHU de Lyon
Lyon, , France
CRF de Valmante
Marseille, , France
CHU de Montpellier
Montpellier, , France
IRR de Nancy
Nancy, , France
CHU de Nantes
Nantes, , France
APHP - Hôpital La Salpétriere
Paris, , France
APHP - Hôpital Lariboisière
Paris, , France
CMRRF Kerpape
Ploemeur, , France
CHU de Reims
Reims, , France
CHU de Rennes
Rennes, , France
CHU de Toulouse
Toulouse, , France
Countries
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References
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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.
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.
Other Identifiers
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REM_AVC
Identifier Type: -
Identifier Source: org_study_id
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