Recruiting

CDOs

Sponsor:

Jason Wilken

Code:

NCT07889765

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Carbon Fiber Custom Dynamic Orthosis

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT07889765

Start date

Nov 1, 2026

Status verified date

Oct, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

51 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: No Visual Feedback

Participants will walk in the study CDO without visual feedback of limb loading during gait.

experimental: Visual Feedback of Forefoot Force

Participants will walk in the study CDO while being provided visual feedback of forefoot loading loading during gait. Forefoot loading will be measured using wireless insoles placed in the CDO footplate.

experimental: Visual Feedback of Cuff Force

Participants will walk in the study CDO while being provided visual feedback of cuff loading loading during gait. Cuff loading will be measured using wireless insoles placed in the CDO proximal cuff.

no intervention: NoCDO

Participants will walk without a CDO.

Interventions

Carbon Fiber Custom Dynamic Orthosis

The carbon fiber custom dynamic orthosis (CDO) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee.

Primary outcome measure

  • Peak Forefoot Force [ Time Frame: Baseline ]
  • Forefoot Force Impulse [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Jason M Wilken, PT, PhD

319-335-6857jason-wilken@uiowa.edu

Kirsten M Anderson, PhD

319-353-0431kirsten-m-anderson@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Jason M Wilken, PT, PhD

319-353-0431jason-wilken@uiowa.edu

Kirsten M Anderson, PhD

319-353-0431kirsten-m-anderson@uiowa.edu

More Information

Sponsor

Jason Wilken

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Carbon Fiber
  • Ankle Foot Orthosis
  • Foot Loading

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Jason Wilken on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.