Functional Electrical Stimulation (FES) for Upper Extremity Hemiplegia in Children With Cerebral Palsy

February 22, 2018 updated by: Holland Bloorview Kids Rehabilitation Hospital

An Evaluation of the Effectiveness of Functional Electrical Stimulation Paired With Intensive Therapy to Improve Hand Function in Children With Hemiplegic Cerebral Palsy

The proposed pilot study seeks to explore the effectiveness of Functional Electrical Stimulation (FES) to improve upper limb function in children and youth (aged 6 to 18 years) with hemiplegic cerebral palsy, as measured by the QUEST grasp score and other secondary outcome measures obtained pre- and post-intervention in a case series study design.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Functional electrical stimulation (FES) has increasingly gained interest as a therapeutic intervention for the improvement of motor function in individuals with disabilities. FES involves the administration of electrical pulses to stimulate motor neurons and initiate muscle contractions, It has been used primarily for individuals with spinal cord injury or those who have experienced a stroke leading to the loss of or decreased motor function of the limbs. The repeated application of FES to the affected limb has been shown to enable individuals with hemiplegia to voluntarily control movements of the affected upper limb. A new FES system, has recently been developed and indicated for use for the improvement of arm and hand function in patients with hemiplegia due to stroke or spinal cord injury. FES is a non-invasive therapy that involves transcutaneous delivery of electrical stimulation to the affected upper limb, patient participation and the assistance of therapists to improve voluntary arm and hand movements such as reaching and grasping.

The new FES system has shown effectiveness in both adults with acute stroke and children with chronic acquired stroke. In a randomized controlled trial, FES paired with intensive therapy compared to intensive therapy alone was shown to significantly improve hand function for adults with acute stroke. Participants in the trial had limited mobility or complete immobility of the affected arm and those who received FES paired with intensive therapy had clinically significant improvements in hand movements compared to those who only received intensive therapy. Recently, transcutaneous FES paired with intensive hand therapy (3 one-hour sessions per week for 16 weeks) has more recently been shown to improve hand function in children with chronic acquired stroke.

The efficacy of FES seen in patients with stroke opens up the possibility for its use in other similar populations, including children with hemiplegic cerebral palsy (HCP). However, there is currently limited research on the efficacy of FES with this population. In a preliminary study, the use of FES alone over a treatment period of 6 weeks in children with HCP was shown to significantly improve wrist movement. However, most of the research to date on the effects of FES on children with HCP has been focused on gait and lower limb function. There is currently a lack of evidence on the effectiveness of FES paired with intensive therapy on hand function in children with HCP. FES paired with intensive therapy holds significant potential to improve the hand function of children with HCP and warrants further investigation.

Therefore, the proposed research seeks to address two main objectives:

  1. To investigate the effectiveness of FES to improve upper limb function in children with HCP.
  2. To assess the effects of FES on upper limb function in children with HCP at six months post-intervention.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of hemiplegic CP
  • Age between 6 to 18 years
  • Ability to cooperate, understand and follow instructions during the administration of FES paired with intensive hand therapy
  • Baseline total QUEST score between 20-80 out of 100 points
  • Be seizure-free for a required period of at least 1 year with or without medication , and have no prior history of known cardiac arrhythmias/stimulants
  • No pacemaker or implanted metallic or electronic device
  • No edema, skin rash, allergy or wound on the affected upper limb where FES will be administered.
  • No Botulinum toxin upper limb injections within 6-months of study entry, and no Constraint-induced movement therapy (CIMT) within 4 months of study entry. Participants should also refrain from receiving these treatments throughout the duration of the study.

Exclusion Criteria:

  • The participant's forearm is too small to accommodate the standard FES electrodes.

  • The participant's muscles do not respond to the electrical stimulation as tested at the baseline assessment visit. Response to electrical stimulation will be tested at the baseline visit and is described in detail in the section entitled "Muscle Responsiveness Testing" below. Based on the Muscle Responsiveness Testing procedures and criteria, the withdrawal criteria for non-response to electrical stimulation is defined as:

    1. More than 3 muscle groups out of 11 not- responding to FES or
    2. The participant reports a discomfort level score of 8 or 10 on the FACES scale (Appendix A) for any of the 11 muscle groups.
  • Participant receives any other active occupational therapy or hemiplegic hand intervention during the FES intervention period.
  • Participant attends less than 36/48 FES intervention sessions.
  • Participant develops new-onset seizures during the FES intervention period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FES Therapy
FES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions.
Device: FES Therapy
FES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Upper Extremities Skills Test (QUEST) as a measure of Movement patterns and hand function
Time Frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Canadian Occupational Performance Measure (COPM) as a measure of change in a child's self-perception of occupational performance over time
Time Frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Grip Strength Test as a measure of hand and forearm muscular strength
Time Frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Jebsen-Taylor Test of Hand Function (JTTHF) as a measure of hand functions required in activities of daily living
Time Frame: Change from Baseline (i.e., prior to intervention), at 4 months post-intervention, and at 6 months post-intervention. JTTHF will also be assessed at 4 weeks, 8 weeks, 12 weeks, and 16 weeks during the intervention period.
Change from Baseline (i.e., prior to intervention), at 4 months post-intervention, and at 6 months post-intervention. JTTHF will also be assessed at 4 weeks, 8 weeks, 12 weeks, and 16 weeks during the intervention period.
Children's Hand-use Experience Questionnaire (CHEQ) as a measure of children's experience in using the affected hand in bi-manual activities
Time Frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Proprioception Task as a measure of joint-position sense
Time Frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Two-point Orientation Discrimination (2POD) as a measure of tactile spatial acuity
Time Frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Stereognosis Test as a measure of is the ability to recognize and identify common objects through tactile manipulation without the use of visual cues
Time Frame: Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention
Change from Baseline (i.e, prior to intervention), at 4 months post-intervention, and at 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Investigators

  • Principal Investigator: Darcy Fehlings, MD, MSc, Holland Bloorview Kids Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

August 25, 2017

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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