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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

September 14, 2005
February 4, 2009
April 2003
June 2005   (final data collection date for primary outcome measure)
  • 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 ]
  • -REL Hand Function Test
  • -Fugl-Meyer Assessment
Complete list of historical versions of study NCT00221078 on ClinicalTrials.gov Archive Site
  • 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 ]
  • -Barthel Index
  • -Functional Independence Measure
  • -Chedoke-McMaster Stages of Motor Recovery
Not Provided
Not Provided
 
Benefits of Applying Neuroprosthesis for Improving Reaching and Grasping Functions in Stroke Patients
Restoration of Reaching and Grasping Functions in Stroke Patients Using Functional Electrical Stimulation.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
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)
Not Provided
Popovic MR, Thrasher TA, Adams ME, Takes V, Zivanovic V, Tonack MI. Functional electrical therapy: retraining grasping in spinal cord injury. Spinal Cord. 2005 Aug 30; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2005
June 2005   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00221078
88098-0461-RR001, 88098-0461-RR001
Yes
M. Popovic, Toronto Rehab Institute
Toronto Rehabilitation Institute
The Physicians' Services Incorporated Foundation
Principal Investigator: Milos Popovic, Ph.D University of Toronto
Toronto Rehabilitation Institute
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP