NCT05726591

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

Recruiting now NA Last updated 27 October 2025

What this trial tests

NA trial testing EA-KAFO in Cerebral Palsy in 44 participants. Currently enrolling.

Timeline

2 May 2023

Primary endpoint
31 October 2027

31 October 2027

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	device feasibility
Enrollment	44
Start date	2 May 2023
Primary completion	31 October 2027
Estimated completion	31 October 2027
Sites	1 location across United States

Drugs / interventions tested

• EA-KAFO

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →
• Muscular Dystrophy — all drugs for Muscular Dystrophy →
• Spina Bifida — all drugs for Spina Bifida →
• Incomplete Spinal Cord Injury — all drugs for Incomplete Spinal Cord Injury →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 3 to 17, any sex, with Cerebral Palsy or Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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....

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized cross-over study protocol to evaluate long-term gait training with a pediatric robotic exoskeleton outside the clinical setting in children with movement disorders.
   Devine TM, Alter KE, Damiano DL, Bulea TC. · · 2024 · cited 3× · PMID 38976710 · DOI 10.1371/journal.pone.0304087
2. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710
3. Gait Event Detection From Thigh Segment Kinematics in Children With Crouch Gait.
   Dembsky J, Rubin N, Bulea TC. · · 2026 · PMID 42146845 · DOI 10.1109/jtehm.2026.3679585