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
NA
22 participants
INTERVENTIONAL
2020-11-30
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Aim 2
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
Variable Stiffness AFO
The Dynamic AFO is able to adjust in stiffness depending on activity.
Aim 3
Participants will be asked to take the Dynamic AFO home and wear the device for up to 4 weeks. The device will be set in either an adjustment-capable mode, or a "locked" mode that functions similar to their own orthotic--the order in which they are tested will be randomized.
Variable Stiffness AFO
The Dynamic AFO is able to adjust in stiffness depending on activity.
Interventions
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Variable Stiffness AFO
The Dynamic AFO is able to adjust in stiffness depending on activity.
Eligibility Criteria
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Inclusion Criteria
* prescribed an offloading Ankle-Foot Orthosis (AFO) for walking/running
* Use prescribed offloading AFO at least 20 hours per week
* Prescribed AFO strut length of at least 200 mm
* Able to run continuously for 1 minute
Exclusion Criteria
* use an assistive device
* Unable to ambulate (walk/run) continuously with AFO for at least 1 minute
* Unable to sit, stand, or negotiate a step onto lab treadmill
18 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
University of Washington
OTHER
Responsible Party
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Joan Sanders
Professor: Engineering
Principal Investigators
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Joan E Sanders, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington, Dept. of Bioengineering
Seattle, Washington, United States
Countries
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Central Contacts
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Katheryn Allyn, CPO, LPO
Role: CONTACT
Facility Contacts
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Daniel Ballesteros
Role: primary
Other Identifiers
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STUDY00009120
Identifier Type: -
Identifier Source: org_study_id
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