Recruiting

CDO

Sponsor:

University of Iowa

Code:

NCT06710119

Conditions

Lower Extremity Injuries

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Visual Feedback

Study Details

Brief summary:

The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.

Conditions

Lower Extremity Injuries

Study ID

NCT06710119

Start date

Jun 18, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Patient Inclusion criteria

  • Ages: 18-65
  • Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
  • Shoe size between women's 8 and 13.5 or men's 6.5 and 13
  • Any of the following: weakness of ankle plantarflexors (<4/5 on MMT), limited pain free ankle motion (DF<10deg or PF<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
  • Ability to walk 25 feet without using a cane or crutch
  • Ability to walk at a slow to moderate pace
  • Able to read and write in English and provide written informed consent

Patient Exclusion criteria

  • Pain > 9/10 while walking
  • Ankle weakness as a result of spinal cord injury or central nervous system pathology
  • AFO or CDO prescription that includes a knee brace or goes up to thigh
  • Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
  • Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
  • BMI greater than 40
  • Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
  • Pregnancy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: No Visual Feedback

Participants will receive typical accommodation training after being prescribed the CDO.

active comparator: Provided Visual Feedback

Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO.

Interventions

Visual Feedback

Visual feedback of foot loading during gait.

Primary outcome measure

  • Peak Plantar Force (Forefoot) [ Time Frame: Baseline ]
  • Plantar Force Impulse (Forefoot) [ 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

Cornerstone Prosthetics and Orthotics

Recruiting

Everett, Washington, United States, 98225

Contacts

Shawna Ziemer, CPO, LPO

319-353-0431wilkenlab@healthcare.uiowa.edu

More Information

Sponsor

University of Iowa

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

  • Gait Analysis
  • Ankle Foot Orthosis
  • Carbon Fiber
  • Biomechanics
  • Visual Feedback
  • Foot Loading

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-12-31.