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

Jason Wilken

Status: Enrolling

Conditions: Foot Injury

Treatments: Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06352788

202007224

CDMRP-OP210038 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 6 patient groups

NoCDO, A, B, C

Experimental group

Description:

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C.

Treatment:

Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, A, C, B

Experimental group

Description:

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration C, and finally CDO configuration B.

Treatment:

Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, B, A, C

Experimental group

Description:

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration A, and finally CDO configuration C.

Treatment:

Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, B, C, A

Experimental group

Description:

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration C, and finally CDO configuration A.

Treatment:

Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, C, A, B

Experimental group

Description:

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration A, and finally CDO configuration B.

Treatment:

Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

NoCDO, C, B, A

Experimental group

Description:

Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration B, and finally CDO configuration A.

Treatment:

Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO)