NCT06498596 Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.
| NCT ID | NCT06498596 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institutes of Health Clinical Center (CC) |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-02-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Cerebral palsy (CP) is the most common motor disorder that affects children. People with CP have weak muscles; they may have trouble controlling the movements of their arms and legs. Researchers have been developing braces called robotic exoskeletons for people with CP. These devices can adapt to the person s movements and help them move better. This natural history study will explore new technologies that may tell us more about how people with CP move and improve how these exoskeletons work. Objective: To test new technologies to measure people s movements and brain function while they move with and without a robotic exoskeleton. Eligibility: People aged 5 to 25 years with CP. Healthy volunteers are also needed. Design: Participants will have 3 to 5 clinic visits in 2 months. Participants will be fitted with an exoskeleton that will be worn on one of their legs. At each visit, participants will be asked to move their wrist, ankle, and knee while the following measurements are taken: Ultrasound. A bar will be placed against the skin. It will send soundwaves into the body to take pictures of the muscles. Electroencephalography (EEG). Participants will wear a cap with sensors. Their brain waves will be recorded. Electromyography (EMG). Small metal discs will be taped to the skin. They will measure electrical activity of muscle. Participants will flex and extend each joint (wrist, ankle, or knee) on one side of their body. These movements will be done on their own and while assisted by two devices: Functional electrical stimulation (FES). Small adhesive pads will be placed on the skin and electric. Pulses will stimulate muscles to help move the limb. This will be done for the wrist, ankle and knee. Robotic Exoskeleton. A leg brace will be placed on one limb with a motor that will help move the knee. The exoskeleton can be used with or without FES. Participants will also walk on a treadmill at their own pace. Photographs and videos will record how they move.
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet criteria 1-4 and 5a as given below. If they also meet 5b, 5c or 6, they will perform the tasks related to the respective joint(s) for which criteria are met, and/or walking.: 1. Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary. 2. Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination. 3. Age 5 to 25 years old. 4. Group A: Have a gait pathology arising from a diagnosis of cerebral palsy. Group B: Healthy volunteers who are age and sex matched to individuals recruited in Group A. 5. Sufficient range of motion to perform the target acquisition task, specifically: 1. Knee joint range of motion of at least 50 degrees in the sagittal plane (knee extension/flexion) assessed with hip extended in supine position. Limited hamstring flexibility as assessed by straight leg raising test does not limit ability to participate in the study. 2. Ankle joint range of motion of at least 40 degrees in the sagittal plane (dorsiplantar- flexion) with the foot in neutral alignment. 3. Wrist joint range of motion of at least 50 degrees in the frontal plane (wrist extension/flexion) assessed with hip extended in standing position. 6. Able to walk at least 1 minute on a treadmill without stopping with or without holding onto side or front support rails. This assessment will be completed by the physician during the medical history and physical exam. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to move the required joints through the necessary range of motion or walk as directed on a treadmill. 2. A history of multiple seizures that have occurred in the past year that are not controlled by medication. 3. Pregnancy.
Contact & Investigator
Thomas C Bulea, Ph.D.
PRINCIPAL INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Frequently Asked Questions
Who can join the NCT06498596 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 25 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06498596 currently recruiting?
Yes, NCT06498596 is actively recruiting participants. Contact the research team at jesse.matsubara@nih.gov for enrollment information.
Where is the NCT06498596 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06498596 clinical trial?
NCT06498596 is sponsored by National Institutes of Health Clinical Center (CC). The principal investigator is Thomas C Bulea, Ph.D. at National Institutes of Health Clinical Center (CC). The trial plans to enroll 30 participants.
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