Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
10 participants
INTERVENTIONAL
2023-10-25
2025-09-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Exoskeleton Walking
Walking with ankle exoskeleton assistance
Ankle Exoskeleton
Walking for twenty minutes with a wearable powered robotic ankle exoskeleton on real-world terrain every day for a week.
Normal walking
Walking under normal conditions (no exoskeleton)
Normal walking
Normal walking for twenty minutes on real-world terrain every day for a week.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
12 Years
45 Years
ALL
No
Sponsors
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Northern Arizona University
OTHER
Responsible Party
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Locations
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Northern Arizona University
Flagstaff, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2137424
Identifier Type: -
Identifier Source: org_study_id
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