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Functional Electrical Stimulation for Children With Upper Limb Weakness Post Stroke

NCT03147794 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-05-10

No results posted yet for this study

Summary

A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). It is a non-invasive application that delivers electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by Health Canada and is indicated as a functional electrical stimulator for improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-C7 spinal cord injury. In a randomized controlled trial looking at adults with acute stroke and limited or complete immobility of the arm, FES and intensive therapy was shown to have significant improvement of hand function compared to the control group that was exposed to intensive therapy only (8). Limited research using MyndMove to administer FES has been conducted for pediatric populations, however there is significant potential for FES and intensive therapy to improve hand function for children with upper extremity hemiparesis using MyndMove technology. Before the efficacy of MyndMove therapy can be evaluated in children age 3 to 6, the tolerability of the system must first be evaluated and proven for this age group.

Conditions

Interventions

DEVICE

MyndMove

A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). It is a non-invasive application that delivers electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by Health Canada and is indicated as a functional electrical stimulator for improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-C7 spinal cord injury.

Sponsors & Collaborators

  • MyndTec Inc.

    collaborator INDUSTRY

  • Holland Bloorview Kids Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Peter Rumney, MD · Holland Bloorview Kids Rehabilitation Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2017-12-31
Completion
2017-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03147794 on ClinicalTrials.gov