Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Fugl Meyer Assessment Scale
Study Overview
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 arm in chronic hemiparetic stroke patients.
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 allows virtual training of Activities of Daily Living (ADL) and therapeutic gaming. A patient-responsive controller enables the assistance of the device only as needed. Chronic stroke patients (>6 months post stroke) will be randomly assigned to either an experimental or a control group. The experimental group will perform task-related intensive therapy with the support of ARMin. Therapists will treat the patients of the control group with standard motor relearning therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
1
Intervention: robot therapy (ARMin) (Device)
2
Intervention: conventional therapy (Other)
Outcomes
Primary Outcomes
Fugl Meyer Assessment Scale
Time Frame: four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up
Secondary Outcomes
- Wolf Motor Function Test, Stroke Impact Scale, Motor Activity Log, modified Ashworth Scale, abnormal joint synergies, active range of motion (ROM), muscle strength, and spatial precision of hand positioning.(three and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
- fMRI(before and after 8 weeks therapy, 2-months follow-up)