Community Testing of Wearable Assistance

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

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Ankle Exoskeleton; Other: Normal walking

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Zach Lerner, PhD; Phone Number: 928-523-1787; Email: zachary.lerner@nau.edu

Study Locations

• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86011
      • Recruiting
      • Northern Arizona University
      • Contact: Zach Lerner, PhD; Phone Number: 928-523-1787; Email: zachary.lerner@nau.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exoskeleton Walking; Walking with ankle exoskeleton assistance	Device: Ankle Exoskeleton; Walking for twenty minutes with a wearable powered robotic ankle exoskeleton on real-world terrain every day for a week.
Placebo Comparator: Normal walking; Walking under normal conditions (no exoskeleton)	Other: Normal walking; Normal walking for twenty minutes on real-world terrain every day for a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	Change in walking speed (measured in meters per second)	through study completion, an average of one week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northern Arizona University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2137424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No