Recruiting

Observational Study

Sponsor:

University of Iowa

Code:

NCT06127316

Conditions

Traumatic Lower Limb Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO)

Study Details

Brief summary:

Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.

Conditions

Traumatic Lower Limb Injury

Study ID

NCT06127316

Start date

Aug 16, 2024

Status verified date

Dec, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ages 18-65 years
2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
3. Mechanical pain with limb loading (>=4/10 on Numerical Pain Rating Scale)
4. Ability to walk 50 feet at a slow to moderate pace
5. Ability to walk without a cane or crutch
6. 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, etc.
3. Ankle weakness resulting from spinal cord injury or central nervous system pathology
4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
5. Rheumatoid or inflammatory arthritis
6. Necrosis of any bones in the foot or ankle
7. Pain of 8/10 or greater during walking
8. Uncorrected visual or hearing impairments
9. Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
10. Pregnancy
11. Body mass index greater than 40 kg/m2

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: NoCDO

Participants will complete study activities without a CDO

experimental: 0cm Distraction

Participants will complete study activities while wearing a CDO with 0cm of heel distraction height

experimental: 1cm Distraction

Participants will complete study activities while wearing a CDO with 1cm of heel distraction height

experimental: 2cm Distraction

Participants will complete study activities while wearing a CDO with 2cm of heel distraction height

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO)

The carbon fiber custom dynamic orthoses (CDOs) 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. The CDO will be modular in design which will allow three carbon fiber struts of the same stiffness and differing lengths to be used to implement 0cm, 1cm, and 2cm levels of heel distraction height. A longer posterior strut will move the carbon fiber footplate away from the participants foot to create the heel distraction height.

Primary outcome measure

  • Peak Force (forefoot) [ Time Frame: Baseline ]
  • Force Impulse (forefoot) [ Time Frame: Baseline ]
  • Peak Force (hindfoot) [ Time Frame: Baseline ]
  • Force Impulse (hindfoot) [ Time Frame: Baseline ]
  • Numerical Pain Rating Scale [ Time Frame: Baseline ]
  • Modified Socket Comfort Score [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

University of Iowa

Last update posted

Jan 15, 2026

Last verified

Dec, 2025

Keywords

  • Plantar Force
  • Ankle Foot Orthosis
  • Carbon Fiber Orthosis
  • Biomechanics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2026-01-15.