Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Contralaterally Controlled Functional Electrical Stimulation for Hand Opening in Hemiplegic Cerebral Palsy: Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925455
• Other study ID #: 16-400
• Secondary ID: 1R21HD088987-01
• Status: Completed
• Phase: N/A
• Start date: October 16, 2016
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2021
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• Hand therapy video games
Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Box and Block Test Score at Treatment End	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.	2 time points: prior to treatment and after 6 weeks of treatment
Other	Change in Instrumented Sine Wave Finger Tracking Error at Treatment End	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.	2 time points: prior to treatment start and at end of treatment week 6.
Other	Number of Cumulative Hand Movement Repetitions During Game Play	The number of hand movement repetitions was computed by calculating the number of hand trajectory direction changes divided by two.	6 weeks
Primary	Change in Assisting Hands Assessment Logit Score at End 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.	2 time points: prior to treatment and at end of 6 weeks of treatment
Secondary	Change in Melbourne 2 Motor Assessment at End 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.	2 time points: prior to treatment and at end of 6 weeks of treatment