RECRUITING

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

Conditions

Foot Injury Ankle Foot Orthosis Carbon Fiber Gait Biomechanics Physical Performance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-02

Study Completion:2028-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06352788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jason M Wilken, PT, PhD

CONTACT

319-335-6857

jason-wilken@uiowa.edu

Molly S Pacha, MS, ATC, LAT

CONTACT

319-290-7596

molly-pacha@uiowa.edu

Principal Investigator

Jason M Wilken, PT, PhD

PRINCIPAL_INVESTIGATOR

University of Iowa

Study Locations (Sites)

Naval Medical Center San Diego - Clinical Biomechanics Laboratory

San Diego, California, 92134

United States

University of Iowa

Iowa City, Iowa, 52242

United States

Minneapolis VA Health Care System - Motion Analysis Laboratory

Minneapolis, Minnesota, 55417

United States

Mayo Clinic - Motion Analysis Lab

Rochester, Minnesota, 55905

United States

Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology

Nashville, Tennessee, 37212

United States

Collaborators and Investigators

Sponsor: Jason Wilken

Jason M Wilken, PT, PhD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-02

Study Completion Date2028-09-01

Study Record Updates

Study Start Date2024-07-02

Study Completion Date2028-09-01

Terms related to this study

Keywords Provided by Researchers

Ankle Foot Orthosis
Carbon Fiber
Gait
Biomechanics
Physical Performance

Additional Relevant MeSH Terms

Foot Injury