NCT06352788

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Jason Wilken · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Foot Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-02
• Primary completion: 2027-08-31
• Completion: 2028-09-01
• First posted: 2024-04-08
• Last updated: 2026-01-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study