Community Testing of Wearable Assistance
1 other identifier
interventional
10
1 country
1
Brief Summary
This feasibility study looks to evaluate ankle exoskeleton assistance in community settings for individuals with cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2023
CompletedStudy Start
First participant enrolled
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedFebruary 6, 2024
January 1, 2024
1.5 years
July 13, 2023
January 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Walking speed
Change in walking speed (measured in meters per second)
through study completion, an average of one week
Secondary Outcomes (3)
Step length
Through study completion, an average of one week
Heart-rate
Through study completion, an average of one week
Perceived exertion
Through study completion, an average of one week
Study Arms (2)
Exoskeleton Walking
EXPERIMENTALWalking with ankle exoskeleton assistance
Normal walking
PLACEBO COMPARATORWalking under normal conditions (no exoskeleton)
Interventions
Walking for twenty minutes with a wearable powered robotic ankle exoskeleton on real-world terrain every day for a week.
Normal walking for twenty minutes on real-world terrain every day for a week.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Arizona University
Flagstaff, Arizona, 86011, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2023
First Posted
February 6, 2024
Study Start
October 25, 2023
Primary Completion
May 1, 2025
Study Completion
September 1, 2025
Last Updated
February 6, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share