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

NCT06498596 | Recruiting

• 2 other identifiers: 10001994001994-CC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To investigate the effectiveness of continuous real-time dynamic ultrasound imaging for tracking joint kinematics in children and young adults with CP.

  The correlation between measured joint kinematics and derived joint kinematics from ultrasound during single degree of freedom movements of the knee, ankle, and wrist.

  3-5 visits

Secondary Outcomes (1)

• To use the multimodal data to characterize the temporal and magnitude relationships between movement initiation in the cortex measured by EEG, muscle electrical activation measured by sEMG, muscle deformation measured by US, and limb movement me...

  3-5 visit

Study Arms (2)

Control

Healthy volunteer

Patient

cerebral palsy (CP)

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Age 5-25 years old male and female. Two groups. 1. Pediatric and young adult outpatients with cerebral palsy (CP) 2. Healthy volunteer the same age as CP.

You may qualify if:

• 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.:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Thomas C Bulea, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse H Matsubara

CONTACT

(301) 451-7530; jesse.matsubara@nih.gov

Thomas C Bulea, Ph.D.

CONTACT

(301) 451-7533; buleatc@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 12, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04-15

Locations

US (1)