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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Holland Bloorview Kids Rehabilitation Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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