Recruiting

P.REX

Sponsor:

NIH

Code:

NCT05726591

Conditions

Cerebral Palsy

Muscular Dystrophy

Spina Bifida

Incomplete Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

EA-KAFO

Study Details

Brief summary:

Background:

People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.

Objective:

To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.

Eligibility:

People aged 3 to 17 years with a gait disorder involving the knee joint.

Design:

Participants will be screened. They will have a physical exam. Their walking ability will be tested.

Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.

The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.

During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.

During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.

Participants walking ability will be retested after each phase....

Conditions

Cerebral Palsy

Muscular Dystrophy

Spina Bifida

Incomplete Spinal Cord Injury

Study ID

NCT05726591

Start date

May 2, 2023

Status verified date

Oct 23, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Group A

12 weeks-study intervention

no intervention: Group B

12 weeks the control first.

Interventions

EA-KAFO

This study tests a single device that contains multiple potential configurations as outlined in Table 1 of the protocol. Each participant be evaluated in multiple configurations, minimally including the baseline configuration and the motor assist condition at the knee.

Primary outcome measure

  • 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. [ Time Frame: 36 Weeks ]

Central Contacts and Locations

Central contacts

Thomas C Bulea, Ph.D.

(301) 451-7533buleatc@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institutes of Health Clinical Center (CC)

Last update posted

Oct 27, 2025

Last verified

Oct 23, 2025

Keywords

  • EEG
  • Muscular Dystophies
  • Cerebral Palsy
  • Knee
  • incomplete spinal cord injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC) on 2025-10-27.