Community Testing of Wearable Assistance

Early Phase 1UnknownNCT06244901

Northern Arizona University10 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

Ankle ExoskeletonDEVICE

Walking for twenty minutes with a wearable powered robotic ankle exoskeleton on real-world terrain every day for a week.

Normal walkingOTHER

Normal walking for twenty minutes on real-world terrain every day for a week.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Northern Arizona University

Flagstaff, Arizona, United States

RECRUITING

Outcomes

Primary Outcomes

Walking speed

Change in walking speed (measured in meters per second)

Time frame: through study completion, an average of one week

Secondary Outcomes

Step length

Change in step length (measured in meters)

Time frame: Through study completion, an average of one week

Heart-rate

Change in heart rate (measured in beats per minute)

Time frame: Through study completion, an average of one week

Perceived exertion

Change in perceived exertion (measured on a 1-10 scale)

Time frame: Through study completion, an average of one week

Central Contacts

Zach Lerner, PhD

CONTACT

928-523-1787 Zachary.Lerner@nau.edu

Data from ClinicalTrials.gov

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