Status:
RECRUITING
Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Muscle Weakness
Problems Moving Their Arms and Legs
Eligibility:
All Genders
5-25 years
Brief Summary
People with cerebral palsy (CP), muscular dystrophy (MD), spina bifida, or spinal cord injury often have muscle weakness, and problems moving their arms and legs. The NIH designed a new brace device, ...
Detailed Description
STUDY DESCRIPTION: The following exploratory observational study is designed to create a framework that permits rapid development, piloting, and acute evaluation of pediatric exoskeleton control para...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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. Importantly, we included young adults (18-25 years old) because longterm outcomes for adults with cerebral palsy include loss of ambulatory ability. While studies of conventional gait training in this population have been conducted, use of exoskeletons in this population is very limited. Given the potential benefit of exoskeletons to reduce knee extension deficiency, it is important to determine whether novel controllers we develop are also tolerated and effective in this age group.
- Either has a gait pathology arising from a diagnosis of CP, MD, SB, or iSCI or has no gait pathology.
- Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension/flexion) assessed with the hip extended in a supine position. Hamstring contracture as assessed by the straight leg raising test does not limit ability to participate in the study.
- Ankle joint range of motion of at least 15 degrees in the sagittal plane (dorsi-plantarflexion) with the foot in neutral alignment.
- Able to walk at least 10 feet without stopping with or without a walking aid.
- 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 CP, MD, SB, or iSCI that would affect the ability to walk as directed with the robotic exoskeleton.
- A history of uncontrolled seizures in the past year.
- Pregnancy based on self-reporting. We excluded pregnancy due to confounding factors of pregnancy on gait.
- Adult unable to consent for themselves at screening visit.
Exclusion
Key Trial Info
Start Date :
January 14 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 18 2028
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06998134
Start Date
January 14 2026
End Date
August 18 2028
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892