Clinical trial NCT01383512: Rehabilitation Robotics After a Stroke
Official title: Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute Stroke
Keywords: stroke
rehabilitation
robotics
motor control
upper limb
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-06-28
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke of the middle cerebral arteria territory
* 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 anterior or posterior cerebral artery
* 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

Primary outcomes:
measure: Fugl Meyer upper limb motor score
timeFrame: Day 30
Secondary outcomes:
measure: Costs
timeFrame: One year
measure: Stroke impact scale (SIS)
timeFrame: One year
measure: Visual analog scale (VAS)
timeFrame: Day 7,14,21,30, 90,180, 360
measure: Modification of motor control
timeFrame: Day 30
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CRRRF
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHRU de Brest
city: Cerbere
country: France
facility: Centre Bouffard Vercelli
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Dijon
country: France
facility: CHU de Dijon
city: Garches
country: France
facility: CH de Garches
city: Granville
country: France
facility: EMPR Le Normandy
city: Le grau du Roi
country: France
facility: CHU de Nîmes
city: Lille
country: France
facility: CHRU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: CHU de Lyon
city: Marseille
country: France
facility: CRF de Valmante
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: IRR de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: APHP - Hôpital La Salpétriere
city: Paris
country: France
facility: APHP - Hôpital Lariboisière
city: Ploemeur
country: France
facility: CMRRF Kerpape
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Brest
name: Olivier REMY-NERIS, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.