Robot suit could help kids with cerebral palsy walk stronger
NCT ID NCT05726591
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a wearable robotic exoskeleton designed to improve walking in children aged 3 to 17 with conditions like cerebral palsy, spina bifida, muscular dystrophy, or incomplete spinal cord injury. The device fits on the legs and can assist or resist movement during walking. Over three 12-week phases, participants will compare their usual therapy with lab-based exoskeleton training and home use of the device. The goal is to see if long-term use improves knee motion and walking speed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pediatric robotic exoskeleton (P.REX/Agilik)
- What this could lead to
- If it works, this could provide a new way to improve walking ability and knee movement in children with certain movement disorders.
- What could go wrong
- This is an early-phase trial with only 44 participants, so results may not apply to all children. The device may be uncomfortable or not improve walking for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 3 to 17 years old. * Have a gait pathology involving the knee joint, from a diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury. * Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension/flexion) assessed with hip extended in supine position. Hamstring contracture as assessed by 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-plantar flexion) with the foot in neutral alignment. * A measured foot-thigh angle of -15 to 30 degrees in prone position. * 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 cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed with the robotic exoskeleton. * A history of uncontrolled seizure in the past year. * Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit. * Any acute cardiopulmonary condition which limits exercise to less than 60 minutes per session or less than 5 days per week.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can virtual reality rewire balance and leg control in cerebral palsy?
- AI learns to spot the two cues that define cerebral palsy motor levels
- Zapping the spine: a Non-Invasive device aims to loosen stiff muscles and improve walking in cerebral palsy
- Robots map how brain and nerve injuries disrupt everyday arm tasks
- Can modified music tunes boost balance in kids with cerebral palsy?