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Completed

NCT Number: NCT00719433

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

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.

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Key information

Conditions

Stroke Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neurologic Manifestations Organizing Pneumonia Paresis Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Upper Extremity Paresis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

robot therapy (ARMin)

Device

therapy of the affected arm with a robot for eight weeks, three times weekly for one hour

Conventional Therapy

Other

physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour

Primary outcomes

  1. 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

  1. 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

  2. fMRI

    Time frame: before and after 8 weeks therapy, 2-months follow-up

    in 20 Patients fMRI will be recorded while patients interact with an MR-compatible manipulandum

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Balgrist University Hospital
  • Reha Rheinfelden
  • Sensory Motor Systems Lab, ETH Zurich
  • Zuercher Hoehenklinik Wald

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 21, 2008
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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