Investigating New Methods to Study Movement in Children and Young Adults With Movement Disorders.
NCT Number: NCT06498596
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Palsy
Sponsor: National Institutes of Health Clinical Center (CC)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-10
Completion Date: 2027-12-31
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

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 3 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.

Primary Outcome Measures: 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 Outcome Measures: 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..., To evaluate the relationship between the dynamics of sEMG activation and ultrasound-derived joint kinematics during a single degree of freedom movement task of the knee, ankle, and wrist - with and without FES - in children and young adults with CP2) To evaluate the correlation between kinematics derived from US imaging of muscles as well as sEMG and the measured joint kinematics during treadmill walking in children and young adults with CP, 3-5 visit