Rehabilitation Robotics After a Stroke (REM_AVC)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Subacute Stroke

Treatments: Other: Self rehabilitation; Device: ARMEO Spring

Study type: Interventional

Funder types: Other

Identifiers

NCT01383512

REM_AVC

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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238 participants in 3 patient groups

Rehabilitation robotics

Experimental group

Description:

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.

Treatment:

Device: ARMEO Spring

Self-rehabilitation

Active Comparator group

Description:

Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation.

Treatment:

Other: Self rehabilitation

Healthy volunteer

Other group

Description:

20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device.

Treatment:

Device: ARMEO Spring