Status:
RECRUITING
Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Cerebral Palsy
Eligibility:
All Genders
5-25 years
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. Rese...
Detailed Description
Study Description: This protocol will explore the use of multimodal signal acquisition techniques such as surface electromyography (sEMG), electroencephalography (EEG), dynamic ultrasound imaging (US...
Eligibility Criteria
Inclusion
- 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.:
- 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.
- 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.
- Age 5 to 25 years old.
- 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.
- Sufficient range of motion to perform the target acquisition task, specifically:
- 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.
- Ankle joint range of motion of at least 40 degrees in the sagittal plane (dorsiplantar- flexion) with the foot in neutral alignment.
- Wrist joint range of motion of at least 50 degrees in the frontal plane (wrist extension/flexion) assessed with hip extended in standing position.
- 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:
- 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.
- A history of multiple seizures that have occurred in the past year that are not controlled by medication.
- Pregnancy.
Exclusion
Key Trial Info
Start Date :
February 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06498596
Start Date
February 20 2025
End Date
December 31 2027
Last Update
September 15 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892