Effect of Custom Dynamic Orthoses on Forefoot Loading

Not Applicable

Not yet recruiting

• Conditions: Lower Extremity Injuries

• Registration Number: NCT06710119
• Lead Sponsor: University of Iowa

Brief Summary

The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.

Detailed Description

This study is designed to evaluate the effects of initial accommodation, CDO related training, and take-home use on foot loading during gait. In this study, adult participants who experienced an injury below the knee and require a CDO will walk without the CDO, then with the CDO following initial prescription, after training with or without visual force feedback, and after additional take-home use of the CDO. Participants will be randomized to to training with or without visual feedback of foot loading forces.

Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).

Study Timeline

• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Study Start: 2025-06-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peak Plantar Force (Forefoot)	Baseline	Maximum force (N) collected from the forefoot (distal 40% of sensor) during gait.
Plantar Force Impulse (Forefoot)	Baseline	Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.

Secondary Outcome Measures

Name	Time	Method
Peak Plantar Force (Midfoot)	Baseline	Maximum force (N) collected from the midfoot (middle 30% of sensor) during gait.
Plantar Force Impulse (Midfoot)	Baseline	Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Peak Plantar Force (Hindfoot)	Baseline	Maximum force (N) collected from the hindfoot (proximal 30% of sensor) during gait.
Plantar Force Impulse (Hindfoot)	Baseline	Plantar force impulse (Ns) across the hindfoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Peak Plantar Force (Total Foot)	Baseline	Maximum force (N) collected from the total foot (100% of sensor) during gait.
Plantar Force Impulse (Total Foot)	Baseline	Plantar force impulse (Ns) across the total foot (100% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.

Trial Locations

Locations (2)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Cornerstone Prosthetics and Orthotics; 🇺🇸 Everett, Washington, United States