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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016923
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: FES Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of the Effectiveness of Functional Electrical Stimulation Paired With Intensive Therapy to Improve Hand Function in Children With Hemiplegic Cerebral Palsy
Study Start Date : March 2016
Actual Primary Completion Date : August 25, 2017
Actual Study Completion Date : August 25, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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. ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016923


Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Investigators
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Principal Investigator: Darcy Fehlings, MD, MSc Holland Bloorview Kids Rehabilitation Hospital
Publications:

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Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03016923    
Other Study ID Numbers: 15-549
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
cerebral palsy
hemiplegia
fes
grasping
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Hemiplegia
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases