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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FES Therapy
Sponsored by
Holland Bloorview Kids Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, hemiplegia, fes, grasping

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FES Therapy

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Quality of Upper Extremities Skills Test (QUEST) as a measure of Movement patterns and hand function

    Secondary Outcome Measures

    Canadian Occupational Performance Measure (COPM) as a measure of change in a child's self-perception of occupational performance over time
    Grip Strength Test as a measure of hand and forearm muscular strength
    Jebsen-Taylor Test of Hand Function (JTTHF) as a measure of hand functions required in activities of daily living
    Children's Hand-use Experience Questionnaire (CHEQ) as a measure of children's experience in using the affected hand in bi-manual activities
    Proprioception Task as a measure of joint-position sense
    Two-point Orientation Discrimination (2POD) as a measure of tactile spatial acuity
    Stereognosis Test as a measure of is the ability to recognize and identify common objects through tactile manipulation without the use of visual cues

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    February 22, 2018
    Sponsor
    Holland Bloorview Kids Rehabilitation Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03016923
    Brief Title
    Functional Electrical Stimulation (FES) for Upper Extremity Hemiplegia in Children With Cerebral Palsy
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    August 25, 2017 (Actual)
    Study Completion Date
    August 25, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Holland Bloorview Kids Rehabilitation Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    cerebral palsy, hemiplegia, fes, grasping

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FES Therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    FES Therapy
    Intervention Description
    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 Measure Information:
    Title
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    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.
    Title
    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
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: More than 3 muscle groups out of 11 not- responding to FES or 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Darcy Fehlings, MD, MSc
    Organizational Affiliation
    Holland Bloorview Kids Rehabilitation Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23584687
    Citation
    Kapadia NM, Nagai MK, Zivanovic V, Bernstein J, Woodhouse J, Rumney P, Popovic MR. Functional electrical stimulation therapy for recovery of reaching and grasping in severe chronic pediatric stroke patients. J Child Neurol. 2014 Apr;29(4):493-9. doi: 10.1177/0883073813484088. Epub 2013 Apr 12.
    Results Reference
    background
    PubMed Identifier
    18971385
    Citation
    Thrasher TA, Zivanovic V, McIlroy W, Popovic MR. Rehabilitation of reaching and grasping function in severe hemiplegic patients using functional electrical stimulation therapy. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):706-14. doi: 10.1177/1545968308317436.
    Results Reference
    background
    PubMed Identifier
    24381377
    Citation
    Kawashima N, Popovic MR, Zivanovic V. Effect of intensive functional electrical stimulation therapy on upper-limb motor recovery after stroke: case study of a patient with chronic stroke. Physiother Can. 2013 Winter;65(1):20-8. doi: 10.3138/ptc.2011-36.
    Results Reference
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    PubMed Identifier
    17299744
    Citation
    Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758.
    Results Reference
    background
    PubMed Identifier
    25276333
    Citation
    Quandt F, Hummel FC. The influence of functional electrical stimulation on hand motor recovery in stroke patients: a review. Exp Transl Stroke Med. 2014 Aug 21;6:9. doi: 10.1186/2040-7378-6-9. eCollection 2014.
    Results Reference
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    PubMed Identifier
    24981060
    Citation
    Meadmore KL, Exell TA, Hallewell E, Hughes AM, Freeman CT, Kutlu M, Benson V, Rogers E, Burridge JH. The application of precisely controlled functional electrical stimulation to the shoulder, elbow and wrist for upper limb stroke rehabilitation: a feasibility study. J Neuroeng Rehabil. 2014 Jun 30;11:105. doi: 10.1186/1743-0003-11-105.
    Results Reference
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    PubMed Identifier
    18305317
    Citation
    Golomb MR, Garg BP, Saha C, Azzouz F, Williams LS. Cerebral palsy after perinatal arterial ischemic stroke. J Child Neurol. 2008 Mar;23(3):279-86. doi: 10.1177/0883073807309246.
    Results Reference
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    PubMed Identifier
    22924431
    Citation
    Prosser LA, Curatalo LA, Alter KE, Damiano DL. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2012 Nov;54(11):1044-9. doi: 10.1111/j.1469-8749.2012.04401.x. Epub 2012 Aug 27.
    Results Reference
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    PubMed Identifier
    11104342
    Citation
    Wright PA, Granat MH. Therapeutic effects of functional electrical stimulation of the upper limb of eight children with cerebral palsy. Dev Med Child Neurol. 2000 Nov;42(11):724-7. doi: 10.1017/s0012162200001341.
    Results Reference
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    PubMed Identifier
    15686289
    Citation
    Postans NJ, Granat MH. Effect of functional electrical stimulation, applied during walking, on gait in spastic cerebral palsy. Dev Med Child Neurol. 2005 Jan;47(1):46-52. doi: 10.1017/s0012162205000083.
    Results Reference
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    PubMed Identifier
    15562409
    Citation
    Staudt M, Gerloff C, Grodd W, Holthausen H, Niemann G, Krageloh-Mann I. Reorganization in congenital hemiparesis acquired at different gestational ages. Ann Neurol. 2004 Dec;56(6):854-63. doi: 10.1002/ana.20297.
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    Functional Electrical Stimulation (FES) for Upper Extremity Hemiplegia in Children With Cerebral Palsy

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