Recruiting
Early Phase 1

Wearable Assistance

Sponsor:

Northern Arizona University

Code:

NCT06244901

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

Interventions

Ankle Exoskeleton

Normal walking

Study Details

Brief summary:

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

Conditions

Cerebral Palsy

Study ID

NCT06244901

Start date

Oct 25, 2023

Status verified date

Jan, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

May 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Exoskeleton Walking

Walking with ankle exoskeleton assistance

placebo comparator: Normal walking

Walking under normal conditions (no exoskeleton)

Interventions

Ankle Exoskeleton

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

Normal walking

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

Primary outcome measure

  • Walking speed [ Time Frame: through study completion, an average of one week ]

Central Contacts and Locations

Central contacts

Zach Lerner, PhD

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

Locations

Northern Arizona University

Recruiting

Flagstaff, Arizona, United States, 86011

Contacts

Zach Lerner, PhD

928-523-1787zachary.lerner@nau.edu

More Information

Sponsor

Northern Arizona University

Last update posted

Feb 6, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northern Arizona University on 2024-02-06.