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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD088987-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation + Video Games | Experimental | 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. |
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| Video Games (no stimulation) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contralaterally-controlled functional electrical stimulation | Device | Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Fu, PhD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44104 | United States | ||
| MetroHealth Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 2 time points: prior to treatment and at end of 6 weeks of treatment |
|
Up to 18 weeks (from baseline to 12 weeks after end of the 6-week treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Fu | Case Western Reserve University and MetroHealth System | 215-368-0355 | mjf24@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2017 | May 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Hand therapy video games | Device | Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements. |
|
| 2 time points: prior to treatment and at end of 6 weeks of treatment |
| 2 time points: prior to treatment and after 6 weeks of treatment |
| 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. |
| 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 |
| Cleveland |
| Ohio |
| 44109 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Manual Ability Classification System | Count of Participants | Participants |
|
| Delivery Type | Count of Participants | Participants |
|
| Affected Hand | Count of Participants | Participants |
|
| Time of injury | Count of Participants | Participants |
|
| Presence of Prenatal Complications | Count of Participants | Participants |
|
| Lesion Type | Count of Participants | Participants |
|
| Lesioned hemisphere | Count of Participants | Participants |
|
| Hand Dominance | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 2 time points: prior to treatment and at end of 6 weeks of treatment |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Number of blocks | 2 time points: prior to treatment and after 6 weeks of treatment |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Percentage of range of motion | 2 time points: prior to treatment start and at end of treatment week 6. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Number of hand movement repetitions | 6 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Dexterity (higher values indicate greater grasp, release, and manipulation ability) |
|
| Fluency (higher values indicate smother, more coordinated motion) |
|