Subacute Stroke
Conditions
Keywords
stroke, rehabilitation, robotics, motor control, upper limb
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.
Interventions
DEVICEARMEO Spring
Use of the device 1 hour per day, 5 days per week during 4 weeks
OTHERSelf rehabilitation
Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.
Sponsors
Ministry of Health, France
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer upper limb motor score | Day 30 | Increase of the Fugl Meyer score between day 0 and day 30 with a difference between groups by at least 4 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) | Day 7,14,21,30, 90,180, 360 | The pain of the shoulder and the upper limb will be assessed in different positions |
| Stroke impact scale (SIS) | One year | The quality of life will be assessed through the SIS. |
| Costs | One year | The rehabilitation costs will be assessed for each group through medical and physiotherapist consultations, hospitalization costs, day of return to work if concerned. |
| Modification of motor control | Day 30 | 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. |
Countries
France
Outcome results
None listed