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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 · National Institutes of Health Clinical Center (CC) · Updated 26 Oct 2026

What is being tested
EA-KAFO
For
Cerebral Palsy; Muscular Dystrophy; Spina Bifida; Incomplete Spinal Cord Injury
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 3 years to 17 years. About 44 people. The full rules are on the registry page.
Where
United States
When
Starts or started 2 May 2023, ends 31 Oct 2027. Registered 14 Feb 2023.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT05726591

Sites

  • National Institutes of Health Clinical CenterBethesda, Maryland, United States