Testing wearable ankle assistance for individuals with cerebral palsy
Community Testing of Wearable Assistance
EARLY_PHASE1 · Northern Arizona University · NCT06244901
This study is testing a special ankle device to see if it can help people with cerebral palsy walk better in their everyday lives.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 12 Years to 45 Years |
| Sex | All |
| Sponsor | Northern Arizona University (other) |
| Locations | 1 site (Flagstaff, Arizona) |
| Trial ID | NCT06244901 on ClinicalTrials.gov |
What this trial studies
This feasibility study evaluates the use of an ankle exoskeleton to assist individuals with cerebral palsy in community settings. Participants will undergo device fitting and practice walking with powered assistance, followed by a series of walking tests to assess performance with and without the device. The study includes a randomized approach to determine the effectiveness of the exoskeleton over a week of independent walking practice. Data on distance, time, heart rate, and perceived exertion will be collected to evaluate the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with cerebral palsy who can walk for at least 20 minutes and fit safely into the exoskeleton device.
Not a fit: Patients with other neurological, musculoskeletal, or cardiorespiratory conditions that impair walking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and independence for individuals with cerebral palsy.
How similar studies have performed: While similar approaches have been explored, this specific community-based application of ankle exoskeletons for cerebral palsy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of cerebral palsy * Gross Motor Function Classification Level I, II, or III * Able to walk for at least 20 minutes with or without a walking aid * Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking * Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used. Exclusion Criteria: * Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time. * Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
Where this trial is running
Flagstaff, Arizona
- Northern Arizona University — Flagstaff, Arizona, United States (RECRUITING)
Study contacts
- Study coordinator: Zach Lerner, PhD
- Email: Zachary.Lerner@nau.edu
- Phone: 928-523-1787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy