Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cerebral Palsy
Interventions Device: Contralaterally-controlled functional electrical stimulation
Device: Hand therapy video games
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stimulation + Video Games Video Games (no Stimulation)
Hide Arm/Group 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.

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.

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.

Period Title: Overall Study
Started 9 6
Completed 7 6
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Stimulation + Video Games Video Games (no Stimulation) Total
Hide Arm/Group 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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 9 6 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 6 participants 15 participants
11.22  (2.86) 12.17  (4.31) 11.60  (3.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Female
5
  55.6%
5
  83.3%
10
  66.7%
Male
4
  44.4%
1
  16.7%
5
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Hispanic or Latino
1
  11.1%
1
  16.7%
2
  13.3%
Not Hispanic or Latino
8
  88.9%
5
  83.3%
13
  86.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  11.1%
0
   0.0%
1
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  33.3%
2
  13.3%
White
7
  77.8%
4
  66.7%
11
  73.3%
More than one race
1
  11.1%
0
   0.0%
1
   6.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Manual Ability Classification System  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Level I: Level 1: Objects are handled easily and successfully
0
   0.0%
0
   0.0%
0
   0.0%
Level 2: Handles most objects but with some reduced quality and/or speed
6
  66.7%
4
  66.7%
10
  66.7%
Level 3: Handles objects with difficulty - child will need help to prepare and/or modify activities
3
  33.3%
2
  33.3%
5
  33.3%
Level 4: Handles limited selection of easily managed objects and always requires some help
0
   0.0%
0
   0.0%
0
   0.0%
The child is not able to handle objects or to complete even simple actions with their hands
0
   0.0%
0
   0.0%
0
   0.0%
Delivery Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Vaginal
4
  44.4%
2
  33.3%
6
  40.0%
Cesarean
5
  55.6%
4
  66.7%
9
  60.0%
Affected Hand  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Right
5
  55.6%
4
  66.7%
9
  60.0%
Left
4
  44.4%
2
  33.3%
6
  40.0%
Time of injury  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Perinatal
2
  22.2%
0
   0.0%
2
  13.3%
Postnatal
1
  11.1%
1
  16.7%
2
  13.3%
Prenatal
4
  44.4%
3
  50.0%
7
  46.7%
Unknown
2
  22.2%
2
  33.3%
4
  26.7%
Presence of Prenatal Complications  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Yes
2
  22.2%
2
  33.3%
4
  26.7%
No
7
  77.8%
4
  66.7%
11
  73.3%
Lesion Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Cystic Encephalomalacia
1
  11.1%
0
   0.0%
1
   6.7%
Encephalomalacia
1
  11.1%
1
  16.7%
2
  13.3%
Hemorrhagic
3
  33.3%
2
  33.3%
5
  33.3%
Ischemic
1
  11.1%
0
   0.0%
1
   6.7%
Periventricular Leukomalacia
1
  11.1%
0
   0.0%
1
   6.7%
Unknown
2
  22.2%
3
  50.0%
5
  33.3%
Lesioned hemisphere  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Bilateral
2
  22.2%
0
   0.0%
2
  13.3%
Left
4
  44.4%
3
  50.0%
7
  46.7%
Right
2
  22.2%
2
  33.3%
4
  26.7%
Unknown
1
  11.1%
1
  16.7%
2
  13.3%
Hand Dominance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Right
4
  44.4%
3
  50.0%
7
  46.7%
Left
5
  55.6%
3
  50.0%
8
  53.3%
1.Primary Outcome
Title Change in Assisting Hands Assessment Logit Score at End of Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stimulation + Video Games Video Games (no Stimulation)
Hide Arm/Group 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.

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.

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 Number of Participants Analyzed 9 6
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
2.63
(0.415 to 4.85)
4.33
(2.44 to 6.23)
2.Secondary Outcome
Title Change in Melbourne 2 Motor Assessment at End of Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stimulation + Video Games Video Games (no Stimulation)
Hide Arm/Group 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.

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.

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 Number of Participants Analyzed 9 6
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Range of Movement (higher values indicate greater shoulder, trunk, elbow, forearm range of motion)
3.50
(-2.20 to 9.19)
6.17
(0.106 to 12.2)
Target Accuracy (higher values indicate closer initial point of sustained contact with objects)
1.91
(-4.63 to 8.45)
-2.00
(-10.1 to 6.08)
Dexterity (higher values indicate greater grasp, release, and manipulation ability)
9.49
(0.317 to 18.7)
7.02
(-0.413 to 14.5)
Fluency (higher values indicate smother, more coordinated motion)
6.39
(-2.99 to 15.8)
3.97
(-0.253 to 8.19)
3.Other Pre-specified Outcome
Title Change in Box and Block Test Score at Treatment End
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stimulation + Video Games Video Games (no Stimulation)
Hide Arm/Group 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.

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.

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 Number of Participants Analyzed 9 6
Mean (95% Confidence Interval)
Unit of Measure: Number of blocks
2.47
(-1.88 to 6.81)
0.667
(-1.85 to 3.19)
4.Other Pre-specified Outcome
Title Change in Instrumented Sine Wave Finger Tracking Error at Treatment End
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stimulation + Video Games Video Games (no Stimulation)
Hide Arm/Group 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.

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.

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 Number of Participants Analyzed 9 6
Mean (95% Confidence Interval)
Unit of Measure: Percentage of range of motion
-3.59
(-5.51 to 01.67)
-3.36
(-6.21 to -0.510)
5.Other Pre-specified Outcome
Title Number of Cumulative Hand Movement Repetitions During Game Play
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stimulation + Video Games Video Games (no Stimulation)
Hide Arm/Group 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.

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.

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 Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: Number of hand movement repetitions
22095  (7385.2) 23035  (16169)
Time Frame Up to 18 weeks (from baseline to 12 weeks after end of the 6-week treatment)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stimulation + Video Games Video Games (no Stimulation)
Hide Arm/Group 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.

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.

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.

All-Cause Mortality
Stimulation + Video Games Video Games (no Stimulation)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Stimulation + Video Games Video Games (no Stimulation)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stimulation + Video Games Video Games (no Stimulation)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Fu
Organization: Case Western Reserve University and MetroHealth System
Phone: 215-368-0355
EMail: mjf24@case.edu
Layout table for additonal information
Responsible Party: Michael Fu, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT02925455    
Other Study ID Numbers: 16-400
1R21HD088987-01 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2016
First Posted: October 5, 2016
Results First Submitted: May 4, 2021
Results First Posted: June 22, 2021
Last Update Posted: June 22, 2021