Phase
Condition
N/ATreatment
Modular Carbon Fiber Custom Dynamic Orthosis (CDO)
Mono Carbon Fiber Custom Dynamic Orthosis (CDO)
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Between the ages of 18 and 65
2 or more years from a traumatic injury below the knee
Ability to be fit with an orthosis
Any of the following:
Weakness of ankle plantarflexors (<4/5 on manual muscle test)
Limited pain-free ankle motion (dorsiflexion (DF) <10° or plantarflexion (PF) <20°)
Mechanical pain with loading to hindfoot/midfoot (>=4/10 Numerical pain ratingscale)
Fusion or candidate for fusion of the ankle or hindfoot
Candidate for amputation secondary to ankle/foot injury and impairment
Exclusion
Exclusion Criteria:
Pain greater than 8/10 at rest
Ankle weakness or spasticity as a result of spinal cord injury or central nervoussystem pathology
Use of an orthosis including the knee
Non-ambulatory
Surgery on study limb anticipated in next 4 months
Medical or psychological conditions that would influence functional testing (e.g.,severe traumatic brain injury, stroke, heart disease, vestibular disorder)
Neurologic, musculoskeletal, or other conditions limiting function of thecontralateral extremity
Uncorrected visual or hearing impairments
Pregnancy
Non-English speaking
BMI > 40
Study Design
Study Description
Connect with a study center
Naval Medical Center San Diego - Clinical Biomechanics Laboratory
San Diego, California 92134
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesActive - Recruiting
Minneapolis VA Health Care System - Motion Analysis Laboratory
Minneapolis, Minnesota 55417
United StatesSite Not Available
Mayo Clinic - Motion Analysis Lab
Rochester, Minnesota 55905
United StatesSite Not Available
Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology
Nashville, Tennessee 37212
United StatesSite Not Available
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