Clinical trial NCT00221078: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: Cerebrovascular Accident
Stroke
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: REL Hand Function Test
timeFrame: 45 min
measure: Fugl-Meyer Assessment
timeFrame: 30 min
Secondary outcomes:
measure: Barthel Index
timeFrame: 25 min
measure: Functional Independence Measure
timeFrame: 25 min
measure: Chedoke-McMaster Stages of Motor Recovery
timeFrame: 30 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: University of Toronto
name: Milos Popovic, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.