Clinical trial NCT06352788: From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Official title: From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Foot Injury
Keywords: Ankle Foot Orthosis
Carbon Fiber
Gait
Biomechanics
Physical Performance
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Vanderbilt University Medical Center
name: Navy Medical Center San Diego
name: Minneapolis Veterans Affairs Medical Center
name: Johns Hopkins University
First posted: 2024-04-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: PROMIS Physical Function
timeFrame: Baseline
measure: PROMIS Pain Interference
timeFrame: Baseline
measure: OPUS Satisfaction with Device and Services
timeFrame: Baseline
measure: Modified Socket Comfort Score - Comfort
timeFrame: Baseline
measure: Modified Socket Comfort Score - Smoothness
timeFrame: Baseline
measure: Numerical Pain Rating Scale
timeFrame: Baseline
measure: Preference - Ranked
timeFrame: Baseline
measure: Preference - CDO Configuration
timeFrame: Baseline
measure: Four Square Step Test (seconds)
timeFrame: Baseline
measure: Sit to Stand 5 Times (seconds)
timeFrame: Baseline
measure: Center of Pressure Velocity Magnitude (m/s)
timeFrame: Baseline
measure: Center of Pressure Velocity Timing (%stance)
timeFrame: Baseline
measure: Ankle Zero Moment Crossing (%stance)
timeFrame: Baseline
measure: Peak Ankle Dorsiflexion (degree)
timeFrame: Baseline
measure: Peak Ankle Plantarflexion Moment (Nm/kg)
timeFrame: Baseline
measure: Peak Ankle Push-Off Power (W/kg)
timeFrame: Baseline
Secondary outcomes:
measure: PROMIS Satisfaction with Participation in Social Activities
timeFrame: Baseline
measure: PROMIS Satisfaction with Participation in Discretionary Social Activities
timeFrame: Baseline
measure: PROMIS Depression
timeFrame: Baseline
Other outcomes:
measure: Ankle Range of Motion (degrees)
timeFrame: Baseline
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego - Clinical Biomechanics Laboratory
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System - Motion Analysis Laboratory
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Motion Analysis Lab
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology
state: Tennessee
Study officials:
affiliation: University of Iowa
name: Jason M Wilken, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: