Community Testing of Wearable Assistance

Early Phase 1

Recruiting

• Conditions: Cerebral Palsy
• Interventions: Device: Ankle Exoskeleton; Other: Normal walking

• Registration Number: NCT06244901
• Lead Sponsor: Northern Arizona University

Brief 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).

Study Timeline

• Study First Submitted: 2023-07-13
• Study Start: 2023-10-25
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-05-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exoskeleton Walking	Ankle Exoskeleton	Walking with ankle exoskeleton assistance
Normal walking	Normal walking	Walking under normal conditions (no exoskeleton)

Primary Outcome Measures

Name	Time	Method
Walking speed	through study completion, an average of one week	Change in walking speed (measured in meters per second)

Secondary Outcome Measures

Name	Time	Method
Step length	Through study completion, an average of one week	Change in step length (measured in meters)
Heart-rate	Through study completion, an average of one week	Change in heart rate (measured in beats per minute)
Perceived exertion	Through study completion, an average of one week	Change in perceived exertion (measured on a 1-10 scale)

Trial Locations

Locations (1)

Northern Arizona University; 🇺🇸 Flagstaff, Arizona, United States