Status:
COMPLETED
Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Sensory Motor Systems Lab, ETH Zurich
Balgrist University Hospital
Conditions:
Stroke
Upper Extremity Paresis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this study is to determine whether task-oriented, robot-aided therapy is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected...
Detailed Description
Robotic therapy will be performed with ARMin, which is a robotic arm exoskeleton that permits 3D movements of both proximal and distal arm joints. Combined with an audiovisual display, this device all...
Eligibility Criteria
Inclusion
- Age 18 or more
- first-ever stroke (hemorrhagic or ischemic), verified by brain imaging
- stroke more than six months prior to the study
- termination of conventional therapy and stable recovery stage (outpatients)
- moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38)
- ability to sit in a chair without any additional support and without leaning on the back rest
- written informed consent signed by the subject (or an authorized representative)
Exclusion
- Excessive spasticity of the affected arm (mAS ≥ 3)
- any serious medical or psychiatric illness
- participation in any clinical investigation within 4 weeks prior to the start of this study
- anticipated need for any major surgery during the study
- women known to be pregnant or lactating
- Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity
- shoulder subluxation (palpatory \> 2 fingers)
- diseased or damaged skin at the paralyzed arm
- inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised
- cyber sickness
- pace-maker or other implanted electric devices
- body weight \> 120kg
- serious cognitive deficits and aphasia preventing the performance of the ARMin treatment
- participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00719433
Start Date
July 1 2008
End Date
September 1 2012
Last Update
April 22 2013
Active Locations (1)
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1
University Hospital Balgrist
Zurich, Canton of Zurich, Switzerland, 8008