Community Testing of Wearable Assistance

Cerebral Palsy Clinical Trial

Official title:

Community Testing of Wearable Assistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244901
• Other study ID #: 2137424
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 25, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: January 2024
• Source: Northern Arizona University
• Contact: Zach Lerner, PhD
• Phone: 928-523-1787
• Email: Zachary.Lerner[@]nau.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
United States	Northern Arizona University	Flagstaff	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Northern Arizona University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed	Change in walking speed (measured in meters per second)	through study completion, an average of one week
Secondary	Step length	Change in step length (measured in meters)	Through study completion, an average of one week
Secondary	Heart-rate	Change in heart rate (measured in beats per minute)	Through study completion, an average of one week
Secondary	Perceived exertion	Change in perceived exertion (measured on a 1-10 scale)	Through study completion, an average of one week