Smart Ankle-Foot Orthosis to Improve Stroke Outcomes: Smart AFO
NCT ID: NCT05619484
Last Updated: 2023-10-10
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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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2022-08-15
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Participant's prescribed ankle-foot orthosis
No interventions assigned to this group
Smart AFO
Smart AFO
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application
Interventions
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Smart AFO
Diagnostic ankle-foot orthosis with AFO stiffness and range of motion settings adjusted using a mobile application
Eligibility Criteria
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Inclusion Criteria
* Mass less than 90 kg (200 lbs)
* At least six months post-stroke
* Hemiplegia or hemiparesis as a result of stroke
* Foot drop during swing phase (often identified by a toe catch), on at least one side
* Current user of an AFO
* Current user of an AFO with a Triple Action Joint is acceptable
* Has bilateral passive ankle range of motion within normal limits
* Able to walk safely on level ground for at least 100 feet without rest
* Able to communicate individual perceptions in the English language
* Able to provide written informed consent
* Participants that will use a treadmill during data collection must also be able to walk independently and safely on an instrumented treadmill
Exclusion Criteria
* Pregnancy
* Not able to read and understand English
* Use of assistive device that requires bilateral upper extremities
18 Years
ALL
No
Sponsors
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Becker Orthopedic
UNKNOWN
University of Utah
OTHER
Orthocare Innovations, LLC
INDUSTRY
Responsible Party
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Locations
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Becker Orthopedic
Troy, Michigan, United States
University of Utah
Salt Lake City, Utah, United States
Orthocare Innovations, LLC
Edmonds, Washington, 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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0019-01
Identifier Type: -
Identifier Source: org_study_id
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