Trial Outcomes & Findings for Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy (NCT NCT02925455)
NCT ID: NCT02925455
Last Updated: 2021-06-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
2 time points: prior to treatment and at end of 6 weeks of treatment
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Stimulation + Video Games
n=9 Participants
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.
|
Video Games (no Stimulation)
n=6 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.22 years
STANDARD_DEVIATION 2.86 • n=5 Participants
|
12.17 years
STANDARD_DEVIATION 4.31 • n=7 Participants
|
11.60 years
STANDARD_DEVIATION 3.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Manual Ability Classification System
Level I: Level 1: Objects are handled easily and successfully
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Manual Ability Classification System
Level 2: Handles most objects but with some reduced quality and/or speed
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Manual Ability Classification System
Level 3: Handles objects with difficulty - child will need help to prepare and/or modify activities
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Manual Ability Classification System
Level 4: Handles limited selection of easily managed objects and always requires some help
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Manual Ability Classification System
The child is not able to handle objects or to complete even simple actions with their hands
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Delivery Type
Vaginal
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Delivery Type
Cesarean
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Affected Hand
Right
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Affected Hand
Left
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Time of injury
Perinatal
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Time of injury
Postnatal
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Time of injury
Prenatal
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Time of injury
Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Presence of Prenatal Complications
Yes
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Presence of Prenatal Complications
No
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Lesion Type
Cystic Encephalomalacia
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Lesion Type
Encephalomalacia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Lesion Type
Hemorrhagic
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Lesion Type
Ischemic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Lesion Type
Periventricular Leukomalacia
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Lesion Type
Unknown
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Lesioned hemisphere
Bilateral
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Lesioned hemisphere
Left
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Lesioned hemisphere
Right
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Lesioned hemisphere
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Hand Dominance
Right
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Hand Dominance
Left
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 time points: prior to treatment and at end of 6 weeks of treatmentParticipants 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.
Outcome measures
| Measure |
Stimulation + Video Games
n=9 Participants
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.
|
Video Games (no Stimulation)
n=6 Participants
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.
|
|---|---|---|
|
Change in Assisting Hands Assessment Logit Score at End of Treatment
|
2.63 Scores on a scale
Interval 0.415 to 4.85
|
4.33 Scores on a scale
Interval 2.44 to 6.23
|
SECONDARY outcome
Timeframe: 2 time points: prior to treatment and at end of 6 weeks of treatmentParticipants 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.
Outcome measures
| Measure |
Stimulation + Video Games
n=9 Participants
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.
|
Video Games (no Stimulation)
n=6 Participants
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.
|
|---|---|---|
|
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
Interval -2.2 to 9.19
|
6.17 units on a scale
Interval 0.106 to 12.2
|
|
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
Interval -4.63 to 8.45
|
-2.00 units on a scale
Interval -10.1 to 6.08
|
|
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
Interval 0.317 to 18.7
|
7.02 units on a scale
Interval -0.413 to 14.5
|
|
Change in Melbourne 2 Motor Assessment at End of Treatment
Fluency (higher values indicate smother, more coordinated motion)
|
6.39 units on a scale
Interval -2.99 to 15.8
|
3.97 units on a scale
Interval -0.253 to 8.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 time points: prior to treatment and after 6 weeks of treatmentThe 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.
Outcome measures
| Measure |
Stimulation + Video Games
n=9 Participants
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.
|
Video Games (no Stimulation)
n=6 Participants
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.
|
|---|---|---|
|
Change in Box and Block Test Score at Treatment End
|
2.47 Number of blocks
Interval -1.88 to 6.81
|
0.667 Number of blocks
Interval -1.85 to 3.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Stimulation + Video Games
n=9 Participants
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.
|
Video Games (no Stimulation)
n=6 Participants
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.
|
|---|---|---|
|
Change in Instrumented Sine Wave Finger Tracking Error at Treatment End
|
-3.59 Percentage of range of motion
Interval -5.51 to 1.67
|
-3.36 Percentage of range of motion
Interval -6.21 to -0.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksThe number of hand movement repetitions was computed by calculating the number of hand trajectory direction changes divided by two.
Outcome measures
| Measure |
Stimulation + Video Games
n=7 Participants
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.
|
Video Games (no Stimulation)
n=6 Participants
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.
|
|---|---|---|
|
Number of Cumulative Hand Movement Repetitions During Game Play
|
22095 Number of hand movement repetitions
Standard Deviation 7385.2
|
23035 Number of hand movement repetitions
Standard Deviation 16169
|
Adverse Events
Stimulation + Video Games
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video Games (no Stimulation)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Fu
Case Western Reserve University and MetroHealth System
Phone: 215-368-0355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place