RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-20
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06498596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. Age 5 to 25 years old.
  4. 4. Group A: Have a gait pathology arising from a diagnosis of cerebral palsy.
  5. 5. Sufficient range of motion to perform the target acquisition task, specifically:
  6. 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.
  7. 2. Ankle joint range of motion of at least 40 degrees in the sagittal plane (dorsiplantar- flexion) with the foot in neutral alignment.
  8. 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.
  9. 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.
  10. 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.
  11. 2. A history of multiple seizures that have occurred in the past year that are not controlled by medication.
  12. 3. Pregnancy.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Jeffrey Fairman
CONTACT
(301) 451-1383
jeffrey.fairman@nih.gov
Thomas C Bulea, Ph.D.
CONTACT
(301) 451-7533
buleatc@mail.nih.gov

Principal Investigator

Thomas C Bulea, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institutes of Health Clinical Center (CC)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institutes of Health Clinical Center (CC)

  • Thomas C Bulea, Ph.D., PRINCIPAL_INVESTIGATOR, National Institutes of Health Clinical Center (CC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-20
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-02-20
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Cerebral Palsy