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

Conditions

• Foot Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Modular Carbon Fiber Custom Dynamic Orthosis (CDO) — DEVICE
  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.
• Mono Carbon Fiber Custom Dynamic Orthosis (CDO) — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jul 2, 2024

Status verified

Dec 2025

Primary completion

Aug 31, 2027

Completion

Sep 1, 2028

Study Design

Enrollment

35 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

PROMIS Physical Function [ Time Frame: Baseline ]

Central Contacts

• Jason M Wilken, PT, PhD
  319-335-6857
  [email protected]
• Molly S Pacha, MS, ATC, LAT
  319-290-7596
  [email protected]

Locations (5)

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