Exploring movement in children and young adults with cerebral palsy

A Natural History Study Evaluating the Use of Multimodal Signal Acquisition Techniques to Characterize Movement in Children and Young Adults With Movement Disorders

This study is testing new technologies to see how children and young adults with cerebral palsy move, both with and without a robotic exoskeleton, to help improve their mobility.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 5 Years to 25 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06498596 on ClinicalTrials.gov

What this trial studies

This observational study investigates new technologies to measure movement and brain function in children and young adults with cerebral palsy (CP). Participants aged 5 to 25 will engage in various movement tasks with and without the assistance of a robotic exoskeleton. The study employs advanced techniques such as ultrasound imaging, electromyography, and electroencephalography to capture and analyze movement data. The goal is to enhance understanding of movement disorders and improve robotic exoskeleton functionality for better mobility.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 5 to 25 with a diagnosis of cerebral palsy, as well as healthy volunteers matched by age and sex.

Not a fit: Patients who do not have cerebral palsy or are outside the age range of 5 to 25 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved mobility solutions for children and young adults with cerebral palsy.

How similar studies have performed: Other studies have shown promise in using similar technologies for movement analysis, but this specific approach is novel.

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 walk as directed with the robotic exoskeleton.
2. A history of multiple seizures that have occurred in the past year that are not controlled by medication.
3. Pregnancy.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Thomas C Bulea, Ph.D. — National Institutes of Health Clinical Center (CC)
• Study coordinator: Jesse H Matsubara

Conditions Cerebral Palsy; Ultrasound; EEG; Exoskeleton; Functional Electrical Stimulation; Walking