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

This study has been completed.
Sponsor:
Collaborators:
Sensory Motor Systems Lab, ETH Zurich
Spinal Cord Injury (SCI) Center, University Hospital Balgrist, Zurich
Reha Rheinfelden
Zuercher Hoehenklinik Wald
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00719433
First received: July 17, 2008
Last updated: April 19, 2013
Last verified: April 2013
  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 Phase
Stroke
Upper Extremity Paresis
Device: robot therapy (ARMin)
Other: conventional therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ] [ 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 ]
  • fMRI [ Time Frame: before and after 8 weeks therapy, 2-months follow-up ] [ Designated as safety issue: No ]
    in 20 Patients fMRI will be recorded while patients interact with an MR-compatible manipulandum


Enrollment: 76
Study Start Date: July 2008
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: robot therapy (ARMin)
therapy of the affected arm with a robot for eight weeks, three times weekly for one hour
Active Comparator: 2 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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Locations
Switzerland
University Hospital Balgrist
Zürich, ZH, 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
Zuercher Hoehenklinik Wald
Investigators
Study Director: Robert Riener, Prof. Sensory Motor Systems Lab, ETH Zürich
Principal Investigator: Armin Curt, Prof. Balgrist University Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00719433     History of Changes
Other Study ID Numbers: SNF ARMin III -1, SNF 325200-120621, EK-39/2007
Study First Received: July 17, 2008
Last Updated: April 19, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
stroke
chronic
rehabilitation
robot therapy
arm therapy

Additional relevant MeSH terms:
Cerebral Infarction
Brain Infarction
Paresis
Stroke
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia

ClinicalTrials.gov processed this record on April 14, 2014