Effect of Custom Dynamic Orthoses on Forefoot Loading

NCT06710119 | Recruiting FDA Device

• 1 other identifier: 202207100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Lower Extremity Injuries

Keywords

Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics; Visual Feedback; Foot Loading

Outcome Measures

Primary Outcomes (2)

• Peak Plantar Force (Forefoot)

  Maximum force (N) collected from the forefoot (distal 40% of sensor) during gait.

  Baseline

• Plantar Force Impulse (Forefoot)

  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.

  Baseline

Secondary Outcomes (6)

• Peak Plantar Force (Midfoot)

  Baseline

• Plantar Force Impulse (Midfoot)

  Baseline

• Peak Plantar Force (Hindfoot)

  Baseline

• Plantar Force Impulse (Hindfoot)

  Baseline

• Peak Plantar Force (Total Foot)

  Baseline

Other Outcomes (7)

• Modified Socket Comfort Score (Comfort)

  Baseline

• Modified Socket Comfort Score (Smoothness)

  Baseline

• Numerical Pain Rating Scale

  Baseline

Study Arms (2)

No Visual Feedback

NO INTERVENTION

Participants will receive typical accommodation training after being prescribed the CDO.

Provided Visual Feedback

ACTIVE COMPARATOR

Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO.

Other: Visual Feedback

Interventions

Visual Feedback OTHER

Visual feedback of foot loading during gait.

Provided Visual Feedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages: 18-65
• Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
• Shoe size between women's 8 and 13.5 or men's 6.5 and 13
• Any of the following: weakness of ankle plantarflexors (\<4/5 on MMT), limited pain free ankle motion (DF\<10deg or PF\<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (\>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
• Ability to walk 25 feet without using a cane or crutch
• Ability to walk at a slow to moderate pace
• Able to read and write in English and provide written informed consent

You may not qualify if:

• Pain \> 9/10 while walking
• Ankle weakness as a result of spinal cord injury or central nervous system pathology
• AFO or CDO prescription that includes a knee brace or goes up to thigh
• Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
• Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
• BMI greater than 40
• Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
• Pregnancy

Sponsors & Collaborators

• University of Iowa: lead
• Cornerstone Clinics, Everett, WA: collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52241, United States

ACTIVE NOT RECRUITING

Cornerstone Prosthetics and Orthotics

Everett, Washington, 98225, United States

RECRUITING

MeSH Terms

Interventions

Feedback, Sensory

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena

Central Study Contacts

Jason M Wilken, PT, PhD

CONTACT

319-335-6857; jason-wilken@uiowa.edu

Kirsten M Anderson, PhD

CONTACT

319-353-0431; kirsten-m-anderson@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will not be blinded to which study arm they are assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will either receive training with or without visual feedback of foot loading during gait.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)