- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02925455
Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy
Contralaterally Controlled Functional Electrical Stimulation for Hand Opening in Hemiplegic Cerebral Palsy: Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, United States, 44104
- Cleveland Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.
Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.
|
Active Comparator: 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 are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Assisting Hands Assessment Logit Score at End of Treatment
Time Frame: 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.
|
2 time points: prior to treatment and at end of 6 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Melbourne 2 Motor Assessment at End of Treatment
Time Frame: 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.
|
2 time points: prior to treatment and at end of 6 weeks of treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Box and Block Test Score at Treatment End
Time Frame: 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. |
2 time points: prior to treatment and after 6 weeks of treatment
|
Change in Instrumented Sine Wave Finger Tracking Error at Treatment End
Time Frame: 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.
|
2 time points: prior to treatment start and at end of treatment week 6.
|
Number of Cumulative Hand Movement Repetitions During Game Play
Time Frame: 6 weeks
|
The number of hand movement repetitions was computed by calculating the number of hand trajectory direction changes divided by two.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael J Fu, PhD, MetroHealth Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-400
- 1R21HD088987-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Contralaterally-controlled functional electrical stimulation
-
National Taiwan University HospitalRecruitingPeripheral Nerve InjuryTaiwan
-
VA Office of Research and DevelopmentCompletedStroke | Upper Extremity HemiplegiaUnited States
-
MetroHealth Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedStroke | Hemiparesis | FootdropUnited States
-
Prof. Dr. Antônio Marcos Vargas da SilvaCompleted
-
University of Sao PauloSuspendedRehabilitation | Critical CareBrazil
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São Paulo; Coordenação de Aperfeiçoamento...Completed
-
National Rehabilitation Center, Seoul, KoreaUnknown
-
University of FloridaCompletedHemiplegia | Cerebrovascular AccidentUnited States
-
University Health Network, TorontoCompletedSpinal Cord Diseases | Spinal Cord InjuriesCanada
-
Riphah International UniversityCompleted