Functional Electrical Stimulation for Children With Upper Limb Weakness Post Stroke

NCT03147794 | Unknown

• 1 other identifier: FES Study
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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

Hemiparesis; Stroke

Outcome Measures

Primary Outcomes (1)

• Wong-Baker Faces Pain Scale

  This is a pain scale.The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst".

  Administered at Appointment 2 (Day 7 of study)

Secondary Outcomes (1)

• Quality of Upper Extremity Skills Test (QUEST)

  Administered at appointment 1 (Day 0 of study)

Study Arms (1)

FES using MyndMove Technology

EXPERIMENTAL

This is the only arm of the study. Participants will be provided with the FES intervention as part of the protocol.

Device: MyndMove

Interventions

MyndMove DEVICE

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.

FES using MyndMove Technology

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• i) Ischaemic or Haemorrhagic stroke with hemiparesis of the upper extremity; ii) Willing to attend therapy; and iii) Communicate effectively in English.

You may not qualify if:

• i) Global aphasia; ii) Upper extremity condition that limits the function of the hand and arm before the stroke; iii) Active seizure disorder within 5 years; iv) Implanted pacemaker, vagal nerve stimulator, AICD, baclofen pump, or similar implanted metallic or electronic device; v) Unhealed fracture or wound in the affected arm; vi) BOTOX injection into the affected arm or hand within 6 months; vii) Currently enrolled in another study of upper limb therapy or new investigational drugs/biologics within 6 months; viii) Swollen, infected or inflamed areas or skin eruptions on the affected arm including evidence of phlebitis or venous incompetence in the arm; ix) Known cardiac dysrhythmia; x) cancerous or suspected cancerous lesions present on the affected arm and xi) Cognitive impairment sufficient enough to impede in the following of directions and understanding of the nature of the therapy, xii) Unwilling/unable to assent to study.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• MyndTec Inc.: collaborator

MeSH Terms

Conditions

Paresis; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Rumney, MD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Rumney, MD

CONTACT

416-425-6220; prumney@hollandbloorview.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: May 10, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share