Recruiting

Observational Study

Sponsor:

Jason Wilken

Code:

NCT06352788

Conditions

Foot Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Study Details

Brief summary:

This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.

Conditions

Foot Injury

Study ID

NCT06352788

Start date

Jul 2, 2024

Status verified date

Dec, 2025

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between the ages of 18 and 65
  • 2 or more years from a traumatic injury below the knee
  • Ability to be fit with an orthosis
  • Any of the following:

  • Weakness of ankle plantarflexors (<4/5 on manual muscle test)
  • Limited pain-free ankle motion (dorsiflexion (DF) <10° or plantarflexion (PF) <20°)
  • Mechanical pain with loading to hindfoot/midfoot (>=4/10 Numerical pain rating scale)
  • Fusion or candidate for fusion of the ankle or hindfoot
  • Candidate for amputation secondary to ankle/foot injury and impairment

Exclusion Criteria:

  • Pain greater than 8/10 at rest
  • Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
  • Use of an orthosis including the knee
  • Non-ambulatory
  • Surgery on study limb anticipated in next 4 months
  • Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
  • Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
  • Uncorrected visual or hearing impairments
  • Pregnancy
  • Non-English speaking
  • BMI > 40

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NoCDO, A, B, C

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C.

experimental: NoCDO, A, C, B

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration C, and finally CDO configuration B.

experimental: NoCDO, B, A, C

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration A, and finally CDO configuration C.

experimental: NoCDO, B, C, A

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration C, and finally CDO configuration A.

experimental: NoCDO, C, A, B

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration A, and finally CDO configuration B.

experimental: NoCDO, C, B, A

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration B, and finally CDO configuration A.

Interventions

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.

Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.

Primary outcome measure

  • PROMIS Physical Function [ Time Frame: Baseline ]
  • PROMIS Pain Interference [ Time Frame: Baseline ]
  • OPUS Satisfaction with Device and Services [ Time Frame: Baseline ]
  • Modified Socket Comfort Score - Comfort [ Time Frame: Baseline ]
  • Modified Socket Comfort Score - Smoothness [ Time Frame: Baseline ]
  • Numerical Pain Rating Scale [ Time Frame: Baseline ]
  • Preference - Ranked [ Time Frame: Baseline ]
  • Preference - CDO Configuration [ Time Frame: Baseline ]
  • Four Square Step Test (seconds) [ Time Frame: Baseline ]
  • Sit to Stand 5 Times (seconds) [ Time Frame: Baseline ]
  • Center of Pressure Velocity Magnitude (m/s) [ Time Frame: Baseline ]
  • Center of Pressure Velocity Timing (%stance) [ Time Frame: Baseline ]
  • Ankle Zero Moment Crossing (%stance) [ Time Frame: Baseline ]
  • Peak Ankle Dorsiflexion (degree) [ Time Frame: Baseline ]
  • Peak Ankle Plantarflexion Moment (Nm/kg) [ Time Frame: Baseline ]
  • Peak Ankle Push-Off Power (W/kg) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Jason M Wilken, PT, PhD

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

Molly S Pacha, MS, ATC, LAT

319-290-7596molly-pacha@uiowa.edu

Locations

Naval Medical Center San Diego - Clinical Biomechanics Laboratory

Recruiting

San Diego, California, United States, 92134

Contacts

Trevor Kingsbury, PhD

trevor.d.kingsbury.civ@health.mil

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Jason M Wilken, PT, PhD

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

Molly S Pacha, MS, ATC, LAT

319-290-7596molly-pacha@uiowa.edu

Minneapolis VA Health Care System - Motion Analysis Laboratory

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

John Looft, PhD

john.looft@va.gov

Mayo Clinic - Motion Analysis Lab

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kenton R Kaufman, PhD

Kaufman.Kenton@mayo.edu

Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Karl Zelik, PhD

karl.zelik@vanderbilt.edu

More Information

Sponsor

Jason Wilken

Last update posted

Jan 15, 2026

Last verified

Dec, 2025

Keywords

  • Ankle Foot Orthosis
  • Carbon Fiber
  • Gait
  • Biomechanics
  • Physical Performance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jason Wilken on 2026-01-15.