Effect of Custom Dynamic Orthoses on Forefoot Loading (LoadsolCP)

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Extremity Injuries
• Intervention / Treatment: Other: Visual Feedback

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason M Wilken, PT, PhD; Phone Number: 319-335-6857; Email: jason-wilken@uiowa.edu
• Study Contact Backup: Name: Kirsten M Anderson, PhD; Phone Number: 319-353-0431; Email: kirsten-m-anderson@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52241
      • Active, not recruiting
      • University of Iowa
  • Washington
    • Everett, Washington, United States, 98225
      • Recruiting
      • Cornerstone Prosthetics and Orthotics
      • Contact: Shawna Ziemer, CPO, LPO; Phone Number: 319-353-0431; Email: wilkenlab@healthcare.uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient Inclusion criteria

• 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

Patient Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Visual Feedback; Participants will receive typical accommodation training after being prescribed the CDO.
Active Comparator: Provided Visual Feedback; Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO.	Other: Visual Feedback; Visual feedback of foot loading during gait.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plantar Force (Midfoot)	Maximum force (N) collected from the midfoot (middle 30% of sensor) during gait.	Baseline
Plantar Force Impulse (Midfoot)	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.	Baseline
Peak Plantar Force (Hindfoot)	Maximum force (N) collected from the hindfoot (proximal 30% of sensor) during gait.	Baseline
Plantar Force Impulse (Hindfoot)	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.	Baseline
Peak Plantar Force (Total Foot)	Maximum force (N) collected from the total foot (100% of sensor) during gait.	Baseline
Plantar Force Impulse (Total Foot)	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.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale	Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.	Baseline
Modified Socket Comfort Score (Comfort)	Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.	Baseline
Modified Socket Comfort Score (Smoothness)	Smoothness scores range from 0 = least smooth to 10 = most smooth.	Baseline
Patient Reported Outcome Measurement Information System (Physical Function)	The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.	Baseline
Patient Reported Outcome Measurement Information System (Pain Interference)	The Patient Reported Outcome Information System (PROMIS) pain interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.	Baseline
Orthotics and Prosthetics User Survey - Satisfaction with Service	Satisfaction with services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Services Score (10-50). Lower scores indicate a better outcome.	Baseline
Orthotics and Prosthetics User Survey - Satisfaction with Device	Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.	Baseline

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: Cornerstone Clinics, Everett, WA

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Biomechanics; Gait Analysis; Carbon Fiber; Ankle Foot Orthosis; Visual Feedback; Foot Loading
• Additional Relevant MeSH Terms: Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Biofeedback, Psychology; Feedback, Psychological; Feedback, Physiological; Homeostasis; Feedback, Sensory
• Other Study ID Numbers: 202207100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No