Home › NCT07889765

Comparative Effect of Training Methods to Reduce Forefoot Loading in Carbon Fiber Custom Dynamic Orthoses

Who can join

Ages 18 to 65 · All sexes · Healthy volunteers welcome

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.

About the study

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.

What is being tested

• Carbon Fiber Custom Dynamic Orthosis (device)

Sponsor: Jason Wilken · Participants: 51 · Started: Nov 1, 2026

Contact the study team

• Jason M Wilken, PT, PhD · Phone: 319-335-6857
• Kirsten M Anderson, PhD · Phone: 319-353-0431

Official record on ClinicalTrials.gov — NCT07889765

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.