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Pediatric Robotic Exoskeleton (P.REX/Agilik) for Movement Disorders

This study is testing a robotic device called the P.REX/Agilik, which is worn on the legs, to see if it can help children aged 3 to 17 years old with movement disorders like cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury. These conditions can cause muscle weakness and difficulty walking. The goal is to find out if using this robotic exoskeleton for a long time can improve how children walk, specifically by helping with knee extension. Researchers will compare using the exoskeleton at home with standard therapy. The study plans to enroll 44 participants, but its current status is unclear.

Study design
This is a randomized crossover study, meaning participants will be assigned to one of two groups and then switch to the other treatment later. It will involve 44 participants.
What's involved
You would be screened, have a physical exam, and your walking ability would be tested. Markers would be placed on your body, and your movements recorded while you walk. You would use the exoskeleton at home for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your walking ability, muscle activity, and motor function will be assessed after the intervention and again 6 weeks later.

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NCT05726591

Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders

Recruiting
NAAges 3–17InterventionalDevice feasibility
National Institutes of Health Clinical Center (CC)
~44 participants
Updated 2025-10-27 on ClinicalTrials.gov
What's tested:EA-KAFO

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD.
Measured over 36 Weeks

Conditions

Cerebral Palsy
Muscular Dystrophy
Spina Bifida
Incomplete Spinal Cord Injury

Explore related trials

Cerebral PalsyIncomplete spinal cord injuryMuscular DystrophySpina Bifida

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

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

Who to contact

Thomas C Bulea, Ph.D.
[email protected]
(301) 451-7533
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD.36 Weeks

    The primary endpoint will be knee extension range of motion. This will be assessed using knee angle at two positions in the gait cycle: knee angle at initial contact and peak knee angle during stance