Cerebral Palsy
Conditions
Keywords
Hemiplegia, Functional Electrical Stimulation, Video Games, Occupational Therapy
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)
Interventions
DEVICEContralaterally-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.
DEVICEHand therapy video games
Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.
Sponsors
The Cleveland Clinic
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Assisting Hands Assessment Logit Score at End of Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Melbourne 2 Motor Assessment at End of Treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Box and Block Test Score at Treatment End | 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 | 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 | 6 weeks | The number of hand movement repetitions was computed by calculating the number of hand trajectory direction changes divided by two. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 9 |
| 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.
Hand therapy video games: Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements. | 6 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Stimulation + Video Games | Total | Video Games (no Stimulation) |
|---|---|---|---|
| Affected Hand Left | 4 Participants | 6 Participants | 2 Participants |
| Affected Hand Right | 5 Participants | 9 Participants | 4 Participants |
| Age, Continuous | 11.22 years STANDARD_DEVIATION 2.86 | 11.60 years STANDARD_DEVIATION 3.4 | 12.17 years STANDARD_DEVIATION 4.31 |
| Delivery Type Cesarean | 5 Participants | 9 Participants | 4 Participants |
| Delivery Type Vaginal | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 13 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hand Dominance Left | 5 Participants | 8 Participants | 3 Participants |
| Hand Dominance Right | 4 Participants | 7 Participants | 3 Participants |
| Lesioned hemisphere Bilateral | 2 Participants | 2 Participants | 0 Participants |
| Lesioned hemisphere Left | 4 Participants | 7 Participants | 3 Participants |
| Lesioned hemisphere Right | 2 Participants | 4 Participants | 2 Participants |
| Lesioned hemisphere Unknown | 1 Participants | 2 Participants | 1 Participants |
| Lesion Type Cystic Encephalomalacia | 1 Participants | 1 Participants | 0 Participants |
| Lesion Type Encephalomalacia | 1 Participants | 2 Participants | 1 Participants |
| Lesion Type Hemorrhagic | 3 Participants | 5 Participants | 2 Participants |
| Lesion Type Ischemic | 1 Participants | 1 Participants | 0 Participants |
| Lesion Type Periventricular Leukomalacia | 1 Participants | 1 Participants | 0 Participants |
| Lesion Type Unknown | 2 Participants | 5 Participants | 3 Participants |
| Manual Ability Classification System Level 2: Handles most objects but with some reduced quality and/or speed | 6 Participants | 10 Participants | 4 Participants |
| Manual Ability Classification System Level 3: Handles objects with difficulty - child will need help to prepare and/or modify activities | 3 Participants | 5 Participants | 2 Participants |
| Manual Ability Classification System Level 4: Handles limited selection of easily managed objects and always requires some help | 0 Participants | 0 Participants | 0 Participants |
| Manual Ability Classification System Level I: Level 1: Objects are handled easily and successfully | 0 Participants | 0 Participants | 0 Participants |
| Manual Ability Classification System The child is not able to handle objects or to complete even simple actions with their hands | 0 Participants | 0 Participants | 0 Participants |
| Presence of Prenatal Complications No | 7 Participants | 11 Participants | 4 Participants |
| Presence of Prenatal Complications Yes | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 11 Participants | 4 Participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 1 Participants |
| Time of injury Perinatal | 2 Participants | 2 Participants | 0 Participants |
| Time of injury Postnatal | 1 Participants | 2 Participants | 1 Participants |
| Time of injury Prenatal | 4 Participants | 7 Participants | 3 Participants |
| Time of injury Unknown | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 6 |
| other Total, other adverse events | 0 / 9 | 0 / 6 |
| serious Total, serious adverse events | 0 / 9 | 0 / 6 |
Outcome results
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.
Time frame: 2 time points: prior to treatment and at end of 6 weeks of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stimulation + Video Games | Change in Assisting Hands Assessment Logit Score at End of Treatment | 2.63 Scores on a scale |
| Video Games (no Stimulation) | Change in Assisting Hands Assessment Logit Score at End of Treatment | 4.33 Scores on a scale |
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.
Time frame: 2 time points: prior to treatment and at end of 6 weeks of treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Stimulation + Video Games | Change in Melbourne 2 Motor Assessment at End of Treatment | Range of Movement (higher values indicate greater shoulder, trunk, elbow, forearm range of motion) | 3.50 units on a scale |
| Stimulation + Video Games | Change in Melbourne 2 Motor Assessment at End of Treatment | Target Accuracy (higher values indicate closer initial point of sustained contact with objects) | 1.91 units on a scale |
| Stimulation + Video Games | Change in Melbourne 2 Motor Assessment at End of Treatment | Dexterity (higher values indicate greater grasp, release, and manipulation ability) | 9.49 units on a scale |
| Stimulation + Video Games | Change in Melbourne 2 Motor Assessment at End of Treatment | Fluency (higher values indicate smother, more coordinated motion) | 6.39 units on a scale |
| Video Games (no Stimulation) | Change in Melbourne 2 Motor Assessment at End of Treatment | Fluency (higher values indicate smother, more coordinated motion) | 3.97 units on a scale |
| Video Games (no Stimulation) | Change in Melbourne 2 Motor Assessment at End of Treatment | Range of Movement (higher values indicate greater shoulder, trunk, elbow, forearm range of motion) | 6.17 units on a scale |
| Video Games (no Stimulation) | Change in Melbourne 2 Motor Assessment at End of Treatment | Dexterity (higher values indicate greater grasp, release, and manipulation ability) | 7.02 units on a scale |
| Video Games (no Stimulation) | Change in Melbourne 2 Motor Assessment at End of Treatment | Target Accuracy (higher values indicate closer initial point of sustained contact with objects) | -2.00 units on a scale |
Other Pre-specified
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.
Time frame: 2 time points: prior to treatment and after 6 weeks of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stimulation + Video Games | Change in Box and Block Test Score at Treatment End | 2.47 Number of blocks |
| Video Games (no Stimulation) | Change in Box and Block Test Score at Treatment End | 0.667 Number of blocks |
Other Pre-specified
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.
Time frame: 2 time points: prior to treatment start and at end of treatment week 6.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stimulation + Video Games | Change in Instrumented Sine Wave Finger Tracking Error at Treatment End | -3.59 Percentage of range of motion |
| Video Games (no Stimulation) | Change in Instrumented Sine Wave Finger Tracking Error at Treatment End | -3.36 Percentage of range of motion |
Other Pre-specified
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stimulation + Video Games | Number of Cumulative Hand Movement Repetitions During Game Play | 22095 Number of hand movement repetitions | Standard Deviation 7385.2 |
| Video Games (no Stimulation) | Number of Cumulative Hand Movement Repetitions During Game Play | 23035 Number of hand movement repetitions | Standard Deviation 16169 |