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

University Hospital, Brest23 sites in 1 country238 target enrollmentJune 2011

ConditionsSubacute Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Subacute Stroke
Sponsor: University Hospital, Brest
Enrollment: 238
Locations: 23
Primary Endpoint: Fugl Meyer upper limb motor score
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

December 5, 2017

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Brest

Responsible Party

Sponsor

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