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

NCT05726591 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-10-27

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726591 on ClinicalTrials.gov