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NCT07889765
Comparative Effect of Training Methods to Reduce Forefoot Loading in Carbon Fiber Custom Dynamic Orthoses
Conditions: Healthy
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 51
Sponsor: Jason Wilken
Location: University of Iowa Iowa City Iowa
Summary
Carbon fiber custom dynamic orthoses (CDOs) include a full-length footplate, a stiff posterior spring, and a cuff that wraps around the leg below the knee. CDOs restore function after limb trauma, decrease forefoot loading, and reduce pain. However, initial introduction to a CDO is not consistent, so this study is being conducted to determine if different methods of training alter forefoot loading during gait. Unimpaired adult participants will be randomized to one of three groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. All participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO.
Eligibility Criteria
Inclusion Criteria:
1. Ages 18-65.
2. Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
3. Ability to hop without pain.
4. Ability to perform a full squat without pain.
5. Ability to read and write in English and provide written informed consent.
Exclusion Criteria:
1. Diagnosis with a moderate or severe brain injury.
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition).
3. Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
4. Medical conditions of injuries limiting function for greater than 6 weeks.
5. Uncorrected visual or hearing impairments.
6. Use of an assistive device.
7. Wounds preventing CDO use
8. Pregnancy
9. Body mass index greater than 35 kg/m2.
Source: ClinicalTrials.gov (NCT07889765). StuddyBuddy aggregates publicly available trial information.