Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new ways to understand how children and young adults with cerebral palsy (CP) move, and how to improve robotic braces called exoskeletons that can help them move better. The goal is to test new technologies that measure movement and brain activity while participants walk and move with these devices. The study is open to children and young adults aged 3 to 25 with CP, as well as healthy volunteers of similar age and gender.

Participants will have 3 to 5 visits to a clinic over two months. During these visits, they will wear a robotic exoskeleton on one leg and perform simple movements like bending their wrist, ankle, and knee. The researchers will use special tools to take pictures of their muscles, measure brain activity, and record how they move, both on their own and with the help of the exoskeleton. The study aims to gather important information that could lead to better treatments for those with CP. If you're interested in participating, it's important to be able to walk for at least a minute on a treadmill and meet some other specific health criteria.

Gender

ALL

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.