NCT04800510

Iterative Design of Custom Dynamic Orthoses

Iterative Design of Custom Dynamic Orthoses and Comprehensive Design of Musculoskeletal Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.

Detailed description

The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses. Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded. The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis

Conditions

• Adult ALL
• Healthy

Interventions

Type	Name	Description
DEVICE	Carbon Fiber Custom Dynamic Orthosis (CDO)	The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.

Timeline

• Start date: 2021-04-21
• Primary completion: 2022-06-25
• Completion: 2022-06-25
• First posted: 2021-03-16
• Last updated: 2026-01-30
• Results posted: 2023-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study