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From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices

NCT ID: NCT06352788

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2028-09-01

Brief Summary

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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.

Detailed Description

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This study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influence outcomes following traumatic lower extremity injury. In this study, adult participants who still experiencing deficits including weakness and/or immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic CDO.

Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order: a proposed optimal benchmark configuration, a variation with the device in more dorsiflexion, and a variation with the device in greater plantarflexion. Multiple well-established tests will be used to compare outcomes between the different configurations.

Conditions

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Foot Injury

Keywords

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Ankle Foot Orthosis Carbon Fiber Gait Biomechanics Physical Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be cast and fit with either a carbon fiber custom dynamic orthosis (CDO) with a modular or mono design. After being fit with the CDO they will complete testing with the CDO in three different configurations (A, B, C) in a randomized order and without the CDO.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Study participants, investigators, and outcome assessors will be blinded to the condition being tested and will only be introduced to each condition as A, B, or C. Only study coordinators, who will verify adherence with the study protocol (CDO configuration), will not be blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type DEVICE

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)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Reaktiv (Fabtech Systems LLC, Everett WA) Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Navy Medical Center San Diego

FED

Sponsor Role collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Jason Wilken

OTHER

Sponsor Role lead

Responsible Party

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Jason Wilken

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jason M Wilken, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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Naval Medical Center San Diego - Clinical Biomechanics Laboratory

San Diego, California, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Minneapolis VA Health Care System - Motion Analysis Laboratory

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic - Motion Analysis Lab

Rochester, Minnesota, United States

Site Status RECRUITING

Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jason M Wilken, PT, PhD

Role: CONTACT

Phone: 319-335-6857

Email: [email protected]

Molly S Pacha, MS, ATC, LAT

Role: CONTACT

Phone: 319-290-7596

Email: [email protected]

Facility Contacts

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Trevor Kingsbury, PhD

Role: primary

Jason M Wilken, PT, PhD

Role: primary

Molly S Pacha, MS, ATC, LAT

Role: backup

John Looft, PhD

Role: primary

Kenton R Kaufman, PhD

Role: primary

Karl Zelik, PhD

Role: primary

Other Identifiers

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202007224

Identifier Type: -

Identifier Source: org_study_id