Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
NCT05726591

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

Led by National Institutes of Health Clinical Center (CC) · Updated on 2025-10-27

44

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 3Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and assent forms for screening and study participation.
  • Willingness and ability to comply with all study procedures and availability for study duration.
  • Age between 3 and 17 years old.
  • Diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury with knee joint gait pathology.
  • Knee joint range of motion of at least 25 degrees in the sagittal plane with hip extended.
  • Ankle joint range of motion of at least 15 degrees in the sagittal plane with foot in neutral alignment.
  • Foot-thigh angle between -15 and 30 degrees in prone position.
  • Ability to walk at least 10 feet without stopping, with or without a walking aid.
Not Eligible

You will not qualify if you...

  • Any neurological, musculoskeletal, or cardiorespiratory condition other than the specified diagnoses that affects walking with the exoskeleton.
  • History of uncontrolled seizures within the past year.
  • Pregnancy or positive pregnancy test at screening.
  • Any acute cardiopulmonary condition limiting exercise to less than 60 minutes per session or less than 5 days per week.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

T

Thomas C Bulea, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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