Community Testing of Wearable Assistance

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Description

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

Targeted Conditions

Study Overview

Start Date
October 25, 2023
Completion Date
September 1, 2025
Enrollment
10
Date Posted
February 6, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Northern Arizona University
Flagstaff, Arizona 86011, United States

Eligibility

Minimum Age (years)
12
Maximum Age (years)
45
Eligibility 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.

Study Contact Info

Study Contact Name
Zach Lerner, PhD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
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).
NCTid (if applicable)
NCT06244901