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
NA
60 participants
INTERVENTIONAL
2025-06-18
2027-12-31
Brief Summary
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Detailed Description
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Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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No Visual Feedback
Participants will receive typical accommodation training after being prescribed the CDO.
No interventions assigned to this group
Provided Visual Feedback
Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO.
Visual Feedback
Visual feedback of foot loading during gait.
Interventions
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Visual Feedback
Visual feedback of foot loading during gait.
Eligibility Criteria
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Inclusion Criteria
* Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
* Shoe size between women's 8 and 13.5 or men's 6.5 and 13
* Any of the following: weakness of ankle plantarflexors (\<4/5 on MMT), limited pain free ankle motion (DF\<10deg or PF\<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (\>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
* Ability to walk 25 feet without using a cane or crutch
* Ability to walk at a slow to moderate pace
* Able to read and write in English and provide written informed consent
Exclusion Criteria
* Ankle weakness as a result of spinal cord injury or central nervous system pathology
* AFO or CDO prescription that includes a knee brace or goes up to thigh
* Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
* Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
* BMI greater than 40
* Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
* Pregnancy
18 Years
65 Years
ALL
No
Sponsors
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Cornerstone Clinics, Everett, WA
UNKNOWN
University of Iowa
OTHER
Responsible Party
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Jason Wilken
Associate Professor
Locations
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University of Iowa
Iowa City, Iowa, United States
Cornerstone Prosthetics and Orthotics
Everett, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Shawna Ziemer, CPO, LPO
Role: primary
Other Identifiers
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202207100
Identifier Type: -
Identifier Source: org_study_id