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Recruiting NCT06352788

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

No phase Interventional Foot Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), Mono Carbon Fiber Custom Dynamic Orthosis (CDO).
Who it may be relevant to
Registry conditions: Foot Injury. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

  • Device 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • PROMIS Satisfaction with Participation in Social Activities [Time frame: Baseline]
  • PROMIS Satisfaction with Participation in Discretionary Social Activities [Time frame: Baseline]
  • PROMIS Depression [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Naval Medical Center San Diego - Clinical Biomechanics Laboratory — San Diego
  • University of Iowa — Iowa City
  • Minneapolis VA Health Care System - Motion Analysis Laboratory — Minneapolis
  • Mayo Clinic - Motion Analysis Lab — Rochester
  • Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology — Nashville

Identifiers

NCT: NCT06352788 · 202007224 · CDMRP-OP210038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗