NCT06998134 · National Institutes of Health Clinical Center (CC)
Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults
What this study is about
People with cerebral palsy (CP), muscular dystrophy (MD), spina bifida, or spinal cord injury often have muscle weakness, and problems moving their treatment group$1 and legs. The NIH designed a new brace device, called an exoskeleton, that is worn on the legs and helps people walk.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Bethesda, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations