Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy - Full Text View

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
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00719433

Purpose

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
Stroke Upper Extremity Paresis	Device: robot therapy (ARMin) Other: conventional therapy

U.S. FDA Resources

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

Further study details as provided by University of Zurich:

Primary Outcome Measures:

Fugl Meyer Assessment Scale [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 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 ] [ Designated as safety issue: No ]

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
1: Experimental	Device: robot therapy (ARMin) therapy of the affected arm with a robot for eight weeks, three times weekly for one hour
2: Active Comparator	Other: conventional therapy physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 to 80 years
first-ever ischemic stroke, 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 10 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
epilepsy or 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719433

Contacts

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

Locations

Switzerland
Uniklinik Balgrist
Zürich, Switzerland, 8008

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

Investigators

Study Director:	Robert Riener, Prof.	Sensory Motor Systems Lab, ETH Zürich
Principal Investigator:	Volker Dietz, Prof.	Uniklinik Balgrist

More Information

description of arm robot This link exits the ClinicalTrials.gov site

Publications:

Nef T, Mihelj M, Riener R. ARMin: a robot for patient-cooperative arm therapy. Med Biol Eng Comput. 2007 Sep;45(9):887-900. Epub 2007 Aug 3.

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

Keywords provided by University of Zurich:

stroke
chronic
rehabilitation
robot therapy
arm therapy

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009