Back to results

Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Contralaterally-controlled functional electrical stimulation

Hand therapy video games

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Hemiplegia, Functional Electrical Stimulation, Video Games, Occupational Therapy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleveland Clinic Foundation
MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stimulation + Video Games

Video Games (no stimulation)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02925455

First Posted

October 3, 2016

Last Updated

June 21, 2021

Sponsor

MetroHealth Medical Center

Collaborators

The Cleveland Clinic, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT02925455

Brief Title

Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

October 16, 2016 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

MetroHealth Medical Center

Collaborators

The Cleveland Clinic, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

Hemiplegia, Functional Electrical Stimulation, Video Games, Occupational Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stimulation + Video Games

Arm Type

Experimental

Arm Description

Arm Title

Video Games (no stimulation)

Arm Type

Active Comparator

Arm Description

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 Type

Device

Intervention Name(s)

Contralaterally-controlled functional electrical stimulation

Intervention Description

Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.

Intervention Type

Device

Intervention Name(s)

Hand therapy video games

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Assisting Hands Assessment Logit Score at End of Treatment

Description

Time Frame

2 time points: prior to treatment and at end of 6 weeks of treatment

Secondary Outcome Measure Information:

Title

Change in Melbourne 2 Motor Assessment at End of Treatment

Description

Time Frame

2 time points: prior to treatment and at end of 6 weeks of treatment

Other Pre-specified Outcome Measures:

Title

Change in Box and Block Test Score at Treatment End

Description

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.

Time Frame

2 time points: prior to treatment and after 6 weeks of treatment

Title

Change in Instrumented Sine Wave Finger Tracking Error at Treatment End

Description

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.

Time Frame

2 time points: prior to treatment start and at end of treatment week 6.

Title

Number of Cumulative Hand Movement Repetitions During Game Play

Description

The number of hand movement repetitions was computed by calculating the number of hand trajectory direction changes divided by two.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J Fu, PhD

Organizational Affiliation

MetroHealth Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44104

Country

United States

Facility Name

MetroHealth Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

We'll reach out to this number within 24 hrs