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Sponsors and Collaborators: |
University of Zurich Sensory Motor Systems Lab, ETH Zurich Spinal Cord Injury (SCI) Center, University Hospital Balgrist, Zurich Reha Rheinfelden Zürcher Höhenklinik Wald |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00719433 |
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.
Condition | Intervention |
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Stroke Upper Extremity Paresis |
Device: robot therapy (ARMin) Other: conventional therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy |
Estimated Enrollment: | 88 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Device: robot therapy (ARMin)
therapy of the affected arm with a robot for eight weeks, three times weekly for one hour
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2: Active Comparator |
Other: conventional therapy
physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Verena Klamroth, Dr. med. | +41 44 632 71 54 | verena.klamroth@mavt.ethz.ch |
Contact: Marco Guidali | +41 44 632 71 54 | marco.guidali@mavt.ethz.ch |
Switzerland | |
Uniklinik Balgrist | |
Zürich, Switzerland, 8008 |
Study Director: | Robert Riener, Prof. | Sensory Motor Systems Lab, ETH Zürich |
Principal Investigator: | Volker Dietz, Prof. | Uniklinik Balgrist |
Responsible Party: | Sensory Motor Systems Lab, Dep. of Mechanical and Process Engineering, ETH Zurich ( Dr. med. Verena Klamroth ) |
Study ID Numbers: | SNF ARMin III -1, SNF 325200-120621, EK-39/2007 |
Study First Received: | July 17, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00719433 |
Health Authority: | Switzerland: Ethikkommission |
stroke chronic rehabilitation robot therapy arm therapy |
Paresis Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Signs and Symptoms Brain Ischemia Neurologic Manifestations Brain Infarction Infarction |
Nervous System Diseases Cardiovascular Diseases |