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

Phase 3

Completed

• Conditions: Stroke

• Registration Number: NCT00221078
• Lead Sponsor: Toronto Rehabilitation Institute

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.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2005-06
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Completion: 2005-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-04
• Last Update Posted: 2009-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
REL Hand Function Test	45 min
Fugl-Meyer Assessment	30 min

Secondary Outcome Measures

Name	Time	Method
Barthel Index	25 min
Functional Independence Measure	25 min
Chedoke-McMaster Stages of Motor Recovery	30 min

Trial Locations

Locations (1)

Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada