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

Last updated: August 26, 2024
Sponsor: Jason Wilken
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Clinical Study ID

NCT06352788
202007224
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ratingscale)

  • Fusion or candidate for fusion of the ankle or hindfoot

  • Candidate for amputation secondary to ankle/foot injury and impairment

Exclusion

Exclusion Criteria:

  • Pain greater than 8/10 at rest

  • Ankle weakness or spasticity as a result of spinal cord injury or central nervoussystem 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 thecontralateral extremity

  • Uncorrected visual or hearing impairments

  • Pregnancy

  • Non-English speaking

  • BMI > 40

Study Design

Total Participants: 35
Treatment Group(s): 2
Primary Treatment: Modular Carbon Fiber Custom Dynamic Orthosis (CDO)
Phase:
Study Start date:
July 02, 2024
Estimated Completion Date:
September 01, 2028

Study Description

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.

Connect with a study center

  • Naval Medical Center San Diego - Clinical Biomechanics Laboratory

    San Diego, California 92134
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Minneapolis VA Health Care System - Motion Analysis Laboratory

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Mayo Clinic - Motion Analysis Lab

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology

    Nashville, Tennessee 37212
    United States

    Site Not Available

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