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NCT05726591 · ClinicalTrials.gov registry record · NA
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
A NA study of Cerebral Palsy and Spina Bifida, sponsored by National Institutes of Health Clinical Center (CC).
- Recruiting
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT05726591: Recruiting NA study of Cerebral Palsy and Spina Bifida, sponsored by National Institutes of Health Clinical Center (CC).
NCT05726591 is a NA study of Cerebral Palsy and Spina Bifida that is actively recruiting participants, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 44 participants, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05726591, a NA study of Cerebral Palsy and Spina Bifida, is actively recruiting participants, sponsored by National Institutes of Health Clinical Center (CC).
- RECRUITING
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
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....
Primary Outcome
The primary endpoint will be knee extension range of motion. This will be assessed using knee angle at two positions in the gait cycle: knee angle at initial contact and peak knee angle during stance
Conditions Studied
Interventions
- DEVICE EA-KAFO
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2023-05-02 |
| Est. Completion | 2027-10-31 |
| Phase | NA |
What NCT05726591 shows while recruiting
NCT05726591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (81% lower).
The record links to 4 conditions, with Cerebral Palsy appearing as the primary indexed condition, and to 1 intervention - of which EA-KAFO is the first listed.
NCT05726591 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05726591 about?
NCT05726591 is a clinical study titled "Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders". 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...
What is the current status of trial NCT05726591?
This trial is currently recruiting. It is a NA study. The enrollment target is 44 participants. The study started on 2023-05-02. Estimated completion is 2027-10-31.
What conditions does trial NCT05726591 study?
This clinical trial studies the following conditions: Cerebral Palsy, Spina Bifida, Muscular Dystrophy, Incomplete Spinal Cord Injury.
What interventions are being tested in trial NCT05726591?
The interventions under investigation include: EA-KAFO (DEVICE).
Who is sponsoring clinical trial NCT05726591?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05726591 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05726591's enrollment target sits among peer trials
44 42nd of 91 higher than 50 of 91 other Cerebral Palsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cerebral Palsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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