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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Neuroprosthesis
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Cerebrovascular Accident, Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toronto Rehabilitation Institute

Outcomes

Primary Outcome Measures

REL Hand Function Test
Fugl-Meyer Assessment

Secondary Outcome Measures

Barthel Index
Functional Independence Measure
Chedoke-McMaster Stages of Motor Recovery

Full Information

First Posted
September 14, 2005
Last Updated
February 4, 2009
Sponsor
Toronto Rehabilitation Institute
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00221078
Brief Title
Benefits of Applying Neuroprosthesis for Improving Reaching and Grasping Functions in Stroke Patients
Official Title
Restoration of Reaching and Grasping Functions in Stroke Patients Using Functional Electrical Stimulation.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Cerebrovascular Accident, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Neuroprosthesis
Other Intervention Name(s)
Functional Electrical Stimulation (FES)
Intervention Description
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.
Primary Outcome Measure Information:
Title
REL Hand Function Test
Time Frame
45 min
Title
Fugl-Meyer Assessment
Time Frame
30 min
Secondary Outcome Measure Information:
Title
Barthel Index
Time Frame
25 min
Title
Functional Independence Measure
Time Frame
25 min
Title
Chedoke-McMaster Stages of Motor Recovery
Time Frame
30 min

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milos Popovic, Ph.D
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16130018
Citation
Popovic MR, Thrasher TA, Adams ME, Takes V, Zivanovic V, Tonack MI. Functional electrical therapy: retraining grasping in spinal cord injury. Spinal Cord. 2006 Mar;44(3):143-51. doi: 10.1038/sj.sc.3101822.
Results Reference
result
PubMed Identifier
28093928
Citation
Marquez-Chin C, Bagher S, Zivanovic V, Popovic MR. Functional electrical stimulation therapy for severe hemiplegia: Randomized control trial revisited. Can J Occup Ther. 2017 Apr;84(2):87-97. doi: 10.1177/0008417416668370. Epub 2017 Jan 17.
Results Reference
derived
Links:
URL
http://www.toronto-fes.ca
Description
Rehabilitation Engineering Laboratory

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

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