NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults
| NCT ID | NCT06998134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institutes of Health Clinical Center (CC) |
| Condition | Muscle Weakness |
| Study Type | OBSERVATIONAL |
| Enrollment | 23 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2028-08-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 23 participants in total. It began in 2026-06-08 with a primary completion date of 2028-08-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, called an exoskeleton, that is worn on the legs and helps people walk. This study is investigating new ways the exoskeleton can be used in multiple settings while performing different walking or movement tasks, which we call ubiquitous use. For example, we will ask you to walk on a treadmill at different speeds, walk up and down a ramp, or walk through an obstacle course. Optionally, the exoskeletons may also use functional electrical stimulation (FES), a system that sends electrical pulses to the muscle to help it move the limb.
Eligibility Criteria
* 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.
Contact & Investigator
Thomas C Bulea, Ph.D.
PRINCIPAL INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Frequently Asked Questions
Who can join the NCT06998134 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 25 Years, studying Muscle Weakness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06998134 currently recruiting?
Yes, NCT06998134 is actively recruiting participants. Contact the research team at jesse.matsubara@nih.gov for enrollment information.
Where is the NCT06998134 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06998134 clinical trial?
NCT06998134 is sponsored by National Institutes of Health Clinical Center (CC). The principal investigator is Thomas C Bulea, Ph.D. at National Institutes of Health Clinical Center (CC). The trial plans to enroll 23 participants.