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RECRUITING
NCT07889765
NA

Comparative Effect of Training Methods to Reduce Forefoot Loading in Carbon Fiber Custom Dynamic Orthoses

Sponsor: Jason Wilken

View on ClinicalTrials.gov

Summary

Carbon fiber custom dynamic orthoses (CDOs) include a full-length footplate, a stiff posterior spring, and a cuff that wraps around the leg below the knee. CDOs restore function after limb trauma, decrease forefoot loading, and reduce pain. However, initial introduction to a CDO is not consistent, so this study is being conducted to determine if different methods of training alter forefoot loading during gait. Unimpaired adult participants will be randomized to one of three groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. All participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2026-11-01

Completion Date

2027-06-01

Last Updated

2026-10-22

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Carbon Fiber Custom Dynamic Orthosis

The carbon fiber custom dynamic orthosis (CDO) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee.

Locations (1)

University of Iowa

Iowa City, Iowa, United States