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Benefits of Applying Neuroprosthesis for Improving Reaching and Grasping Functions in Stroke Patients

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00221078
First received: September 14, 2005
Last updated: February 4, 2009
Last verified: February 2009
History of Changes
  Purpose

Functional electrical stimulation (FES) is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing. Final goal of the study is to evaluate if FES training when applied early during rehabilitation will help stroke patients to use their hands more effectively after discharge from a rehabilitation facility, compared to those patients who have not received FES training.


Condition Intervention Phase
Stroke
 Device: Neuroprosthesis
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Restoration of Reaching and Grasping Functions in Stroke Patients Using Functional Electrical Stimulation.

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • REL Hand Function Test [ Time Frame: 45 min ] [ Designated as safety issue: No ]
  • Fugl-Meyer Assessment [ Time Frame: 30 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Barthel Index [ Time Frame: 25 min ] [ Designated as safety issue: Yes ]
  • Functional Independence Measure [ Time Frame: 25 min ] [ Designated as safety issue: Yes ]
  • Chedoke-McMaster Stages of Motor Recovery [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 2003
Study Completion Date: December 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Neuroprosthesis
    The Compex Motion neuroprosthesis, developed by Drs.R. Popovic and Thierry Keller, and company Compex SA, is a flexible device designed to improve grasping function in both SCI and stroke patients. This multi-channel surface stimulation system for grasping provides both palmar and lateral grasp, and holds a number of advantages over the other existing neuroprostesis.
    Other Name: Functional Electrical Stimulation (FES)
Detailed Description:

Neuroprosthesis are systems that apply functional electrical stimulation to cause muscle contractions. If the muscle contractions are sequenced properly one can generate various functions such as grasping, standing, and walking. Recent studies of others and our pilot study indicate that a neuroprosthesis can be successfully applied as a training device to help stroke patients who have hemiplegic arm to relearn how to reach and grasp various objects. The objective of this research program is to confirm these preliminary results with the broader population of stroke patients, and if successful to propose a method to introduce this rehabilitation treatment into Toronto Rehabilitation Institute, Stroke Unit as a primary intervention for hand function recovery. Specifically, our aim is to1)develop an exercise protocol that uses a neuroprosthesis for reaching and grasping developed by our team in combination with the standard physiotherapy treatments to enhance recovery of hemiplegic arm and hand; and 2) assess qualitatively and quantitatively improvements in the reaching and grasping functions achieved with standard rehabilitation treatment.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be motivated to participate in the FES study, and must sign the letter of consent.
  • Patients must have hemiplegia and the stroke must be confirmed with a CT scan.
  • Patients must understand that the role of this study is to enhance recovery and not to guarantee it.

Exclusion Criteria:

  • Patients who is motivated and does not sign the letter of consent.
  • Patient who has serious cognitive or psychological impairments.
  • Patients who has skin rush, allergy or wounds.
  • Alcohol or drug abuse.
  • Edema in his/her upper extremity.
  • Patients with Shoulder Hand Syndrome
  • Global aphasia
  • Patients who shows early recovery of the function.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221078

Locations
Canada, Ontario
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M5G 2A2
Sponsors and Collaborators
Toronto Rehabilitation Institute
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Milos Popovic, Ph.D University of Toronto
  More Information

Additional Information:
Rehabilitation Engineering Laboratory  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: M. Popovic, Toronto Rehab Institute
ClinicalTrials.gov Identifier: NCT00221078     History of Changes
Other Study ID Numbers: 88098-0461-RR001, 88098-0461-RR001
Study First Received: September 14, 2005
Last Updated: February 4, 2009
Health Authority: Canada: Health Canada

Keywords provided by Toronto Rehabilitation Institute:
Cerebrovascular Accident
Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 17, 2013