Cerebral PalsyNCT02925455
Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy
A study testing Hand therapy video games in people with Cerebral Palsy, run by MetroHealth Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hand therapy video games
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2016to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44104
MetroHealth Medical Center
Cleveland, Ohio, 44109
About this study
Official title: Contralaterally Controlled Functional Electrical Stimulation for Hand Opening in Hemiplegic Cerebral Palsy: Pilot Randomized Controlled Trial
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.
Read the 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)
- Conditions
- Cerebral Palsy
- Being tested
- Contralaterally-controlled functional electrical stimulation, Hand therapy video games
- Keywords
- Hemiplegia, Functional Electrical Stimulation, Video Games, Occupational Therapy
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contralaterally-controlled functional electrical stimulationDevice
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 gamesDevice
Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Contralaterally-controlled functional electrical stimulation; Device: Hand therapy video games |
| 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. Receives: Device: Hand therapy video games |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 time points: prior to treatment and at end of 6 weeks of treatment
Secondary outcomes (1)
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.
Measured: 2 time points: prior to treatment and at end of 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start16 Oct 2016
- Primary completion31 Dec 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michael Fu, MetroHealth Medical Center
- Investigators
- Michael J Fu, PhD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925455
- Sponsor's protocol ID
- 16-400
- Other IDs
- 1R21HD088987-01
- Status last verified
- Jun 2021
- First submitted
- 3 Oct 2016
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralaterally Controlled Functional Electrical Stimulation for Hand Opening in Hemiplegic Cerebral Palsy: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02925455
- Acronym / sponsor ID
- 16-400
- Conditions
- Cerebral Palsy
- Keywords
- Hemiplegia, Functional Electrical Stimulation, Video Games, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 Oct 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation + Video Games | Experimental | Device: Contralaterally-controlled functional electrical stimulation, Device: Hand therapy video gamesContralaterally-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. |
| Video Games (no stimulation) | Active comparator | Device: Hand therapy video gamesParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contralaterally-controlled functional electrical stimulationContralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb. | Device | Stimulation + Video Games |
| Hand therapy video gamesHand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements. | Device | Stimulation + Video Games, Video Games (no stimulation) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Fu, PhD principal investigator
MetroHealth Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand therapy video games in people with Cerebral Palsy, run by MetroHealth Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.