Benefits of Applying Neuroprosthesis for Improving Reaching and Grasping Functions in Stroke Patients - Full Text View

Sponsors and Collaborators:	Toronto Rehabilitation Institute The Physicians' Services Incorporated Foundation
Information provided by:	Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:	NCT00221078

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 III

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Restoration of Reaching and Grasping Functions in Stroke Patients Using Functional Electrical Stimulation.

Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:

REL Hand Function Test
Fugl-Meyer Assessment

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	April 2003
Estimated Study Completion Date:	December 2005

Detailed Description:

Neuroprostheses 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

Rehabilitation Engineering Laboratory This link exits the ClinicalTrials.gov site

Publications of Results:

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]

Study ID Numbers:	88098-0461-RR001, 88098-0461-RR001
Study First Received:	September 14, 2005
Last Updated:	September 21, 2006
ClinicalTrials.gov Identifier:	NCT00221078
Health Authority:	Canada: Health Canada

Keywords provided by Toronto Rehabilitation Institute:

Cerebrovascular Accident
Stroke

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009