NCT06244901

Community Testing of Wearable Assistance

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Northern Arizona University · Academic / Other
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This feasibility study looks to evaluate ankle exoskeleton assistance in community settings for individuals with cerebral palsy.

Detailed description

Participants will undergo consent (if not done over the phone), history/physical/activity questionnaire, and orthotic device fitting. Following device fitting, the participants will practice walking with powered assistance. Next, participants will complete "pre" walking tests with and without the device (order randomized) on a 15-minute pre planned community walk in close proximity with their own home. Distance, time, heart-rate, and perceived exertion will be recorded. The expected duration is 1-2 hours. Next, participants will be asked to complete (under parental supervision for minors) the pre-determined walking route every day for 1 week with or without ankle exoskeleton assistance (block randomized). Following the first week of independent walking practice, participants will complete "post" walking tests with and without the device on the same walking route. Distance, time, heart-rate, and perceived exertion will be recorded. The expected duration is 1-2 hours. Participants will then have a 2-6 week washout period. Following this washout, the pre- and post-assessments will be completed before and after, respectively, another week of identical community walking practice completed under the remaining condition (either exoskeleton or no exoskeleton).

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	Ankle Exoskeleton	Walking for twenty minutes with a wearable powered robotic ankle exoskeleton on real-world terrain every day for a week.
OTHER	Normal walking	Normal walking for twenty minutes on real-world terrain every day for a week.

Timeline

• Start date: 2023-10-25
• Primary completion: 2025-05-01
• Completion: 2025-09-01
• First posted: 2024-02-06
• Last updated: 2024-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study