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Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02925455
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : June 22, 2021
Last Update Posted : June 22, 2021
Sponsor:
Collaborators:
The Cleveland Clinic
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Michael Fu, MetroHealth Medical Center

Tracking Information
First Submitted Date  ICMJE October 3, 2016
First Posted Date  ICMJE October 5, 2016
Results First Submitted Date  ICMJE May 4, 2021
Results First Posted Date  ICMJE June 22, 2021
Last Update Posted Date June 22, 2021
Actual Study Start Date  ICMJE October 16, 2016
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2021)
Change in Assisting Hands Assessment Logit Score at End of Treatment [ Time Frame: 2 time points: prior to treatment and at end of 6 weeks of treatment ]
Participants played a game that required them to perform bimanual tasks while being video recorded. The amount of involvement of the affected arm is scored by viewing the video and converted into a logit score (0-100), with a higher value indicating a better outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
Change in Assisting Hands Assessment at 6 weeks [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2021)
Change in Melbourne 2 Motor Assessment at End of Treatment [ Time Frame: 2 time points: prior to treatment and at end of 6 weeks of treatment ]
Participants perform 14 test tasks that require reach, grasp, release, and manipulation of simple objects. A video of the test is recorded for scoring across the 30 score items using a three, four or five point scale (higher values indicating better outcomes). Item scores relating to four elements of movement are measured and summed within the corresponding sub-scale. A percentage of the total score (range 0-100%) for each subscale is computed and reported separately, with higher values indicating better outcomes.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
Change in Melbourne 2 Motor Assessment at 6 weeks [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2021)
  • Change in Box and Block Test Score at Treatment End [ Time Frame: 2 time points: prior to treatment and after 6 weeks of treatment ]
    The Box and Blocks test counts how many times the participant can pick up 1 block at t time, move it over a partition, and release it in a target area within 60 seconds. The minimum score is 0. There is no maximum score. The average score of healthy individuals within the age range of this study ranges from 70 to 79. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged.
  • Change in Instrumented Sine Wave Finger Tracking Error at Treatment End [ Time Frame: 2 time points: prior to treatment start and at end of treatment week 6. ]
    Finger movement tracking is a method of measuring motor control. The degree of finger extension will be displayed as a cursor on a computer screen, its vertical position corresponding to the degree of finger extension. A sinusoidal trace having a frequency of 0.1 Hz (1 cycle in 10 seconds) will scroll across the screen. The amplitude of the sine-wave track will be scaled so that it oscillates between 15% and 85% of the participant's full active finger extension. The participant will be seated with the wrist and forearm stabilized in a neutral posture. The participant's task is to keep the cursor on or as close to the scrolling trace as possible by extending and flexing their index finger. The vertical distance between the cursor and the target trace will be calculated for every time point of data collected. The error for each 30-sec trial will be the average vertical distance that is equivalent to a percentage of volitional range of motion.
  • Number of Cumulative Hand Movement Repetitions During Game Play [ Time Frame: 6 weeks ]
    The number of hand movement repetitions was computed by calculating the number of hand trajectory direction changes divided by two.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy
Official Title  ICMJE Contralaterally Controlled Functional Electrical Stimulation for Hand Opening in Hemiplegic Cerebral Palsy: Pilot Randomized Controlled Trial
Brief Summary This is a pilot randomized controlled trial of an intervention to improve arm function in children ages 6 to 17 with cerebral palsy and upper limb hemiparesis. Twenty participants will be randomized to either a group treated with neuromuscular electrical stimulation and video games or video games alone. Both groups will receive 6 wks of treatment consisting of home and lab sessions. Both the experiment group and control group interventions consist of therapist-guided sessions in the rehabilitation clinic and self-administered or caregiver-assisted sessions at home. While both groups will receive the same task practice and video game training, only the experiment group will receive an electrical stimulation device to assist with hand opening during practice. Changes in upper extremity motor impairment and function will be assessed for each participant at baseline, mid treatment, end of treatment and at 3 mo follow-up.
Detailed Description

Rehabilitation clinic sessions - These will occur up to twice per week for the first 3 weeks and once per week for the second 3 weeks of the 6 week treatment. They are therapist-guided and last up to 90 min consisting of 45 minutes of contralaterally-controlled functional electrical stimulation (CCFES)-mediated video games and up to 45 minutes of CCFES-mediated functional task practice. Early sessions will focus on training the patient and caregiver to self-administer play of a CCFES-mediated video game at home. As proficiency with one game develops, more games will be introduced. The functional task practice part of the session will engage the participant in using the CCFES system to assist them in practicing using their hand in activities such as lacing beads, throwing balls, eating finger foods, and other play and activities of daily living. Prior to the start of lab treatment, the investigators will assess hand extensor and flexor muscle co-activation (see below).

Home sessions - These consist of CCFES-mediated hand opening and video game exercises with caregiver assistance and supervision as needed. As proficiency develops and more games are added, each home session will increase in duration up to 90 minutes per day, as determined by the treating therapist based on the adherence of each participant. Self report of game difficulty and engagement will be made at the completion of each game (see below)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • Device: Contralaterally-controlled functional electrical stimulation
    Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.
  • Device: Hand therapy video games
    Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.
Study Arms  ICMJE
  • Experimental: Stimulation + Video Games
    Contralaterally-controlled functional electrical stimulation (CCFES) enables patients with upper extremity hemiplegia to open their paretic hand by stimulating finger and thumb extensors with surface electrodes. CCFES is used during functional task practice and hand therapy video games to link motor intent with execution. Four intuitive and engaging games were developed to provide goal-oriented motor skill training, impairment-appropriate difficulty, and performance feedback that motivates iterative play and skill improvement.
    Interventions:
    • Device: Contralaterally-controlled functional electrical stimulation
    • Device: Hand therapy video games
  • Active Comparator: Video Games (no stimulation)
    Participants receive duration-matched, identical hand therapy video games and task practice therapy as the experiment arm, but do not receive CCFES to assist hand opening.
    Intervention: Device: Hand therapy video games
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2021)
15
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2016)
20
Actual Study Completion Date  ICMJE April 30, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Upper Extremity hemiparesis from Cerebral Palsy
  • Age 6-17
  • Caregiver can transport participant to weekly sessions and assist with home treatment
  • Medically stable; stable medications
  • Recall 2 of 3 items after 30 min
  • Finger extension strength ≤ 4/5 on paretic side
  • Able to follow 3-stage commands
  • Adequate active movement of paretic arm to position the hand for table-top task practice
  • Skin intact on hemiparetic arm
  • Surface neuromuscular electrical stimulation trial opens hand without pain
  • Full volitional hand opening and closing of contralateral hand
  • Box & Blocks Score of weaker side < 90% of stronger side score
  • Able to hear and respond to auditory cues
  • English proficiency of both caregiver and child

Exclusion Criteria:

  • Uncontrolled seizure disorder
  • Co-existing neurological conditions other than cerebral palsy affecting the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis, stroke, hemispherectomy)
  • Severely impaired cognition and communication
  • History of cardiac arrhythmias with hemodynamic instability
  • Insensate arm, forearm, or hand
  • Uncompensated hemi-neglect
  • Cardiac pacemaker or any other implanted electronic systems
  • Pregnant
  • Intramuscular Botox injections in any upper extremity muscle in the last 3 months
  • Severe visual impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02925455
Other Study ID Numbers  ICMJE 16-400
1R21HD088987-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Fu, MetroHealth Medical Center
Study Sponsor  ICMJE MetroHealth Medical Center
Collaborators  ICMJE
  • The Cleveland Clinic
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Michael J Fu, PhD MetroHealth Medical Center
PRS Account MetroHealth Medical Center
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP