Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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....
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05726591
The ClinicalTrials.gov registry entry for NCT05726591 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (81% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Cerebral Palsy
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.
-
Motor Training for Infants With Cerebral Palsy
RECRUITING · NA
-
Implementation of Therapy Together
RECRUITING · NA
-
Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy
RECRUITING · NA
-
Neuromodulation of the Cortex and Spinal Cord
RECRUITING · NA
-
Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth With Cerebral Palsy
RECRUITING · NA
-
Gait Adaptation and Biofeedback for Cerebral Palsy
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.