Rehabilitation Robotics After a Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke

Conditions
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Subacute Stroke

Intervention / Treatment
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* Device: ARMEO Spring
* Other: Self rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation robotics<br>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. | Device: ARMEO Spring<br>* Use of the device 1 hour per day, 5 days per week during 4 weeks<br>|
| Active Comparator: Self-rehabilitation<br>Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation. | Other: Self rehabilitation<br>* Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.<br>|
| Other: Healthy volunteer<br>20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device. | Device: ARMEO Spring<br>* Use of the device 1 hour per day, 5 days per week during 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, rehabilitation, robotics, motor control, upper limb