RECRUITING

The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses

Conditions

Traumatic Lower Limb Injury Plantar Force Ankle Foot Orthosis Carbon Fiber Orthosis Biomechanics

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.

Official Title

The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses

Quick Facts

Study Start:2024-08-16

Study Completion:2025-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06127316

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ages 18-65 years 2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle) 3. Mechanical pain with limb loading (\>=4/10 on Numerical Pain Rating Scale) 4. Ability to walk 50 feet at a slow to moderate pace 5. Ability to walk without a cane or crutch 6. Ability to read and write in English and provide written informed consent	1. Diagnosis with a moderate or severe brain injury 2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc. 3. Ankle weakness resulting from spinal cord injury or central nervous system pathology 4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity 5. Rheumatoid or inflammatory arthritis 6. Necrosis of any bones in the foot or ankle 7. Pain of 8/10 or greater during walking 8. Uncorrected visual or hearing impairments 9. Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.) 10. Pregnancy 11. Body mass index greater than 40 kg/m2

Inclusion Criteria

Exclusion Criteria

1. Ages 18-65 years
2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
3. Mechanical pain with limb loading (\>=4/10 on Numerical Pain Rating Scale)
4. Ability to walk 50 feet at a slow to moderate pace
5. Ability to walk without a cane or crutch
6. Ability to read and write in English and provide written informed consent

1. Diagnosis with a moderate or severe brain injury
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc.
3. Ankle weakness resulting from spinal cord injury or central nervous system pathology
4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
5. Rheumatoid or inflammatory arthritis
6. Necrosis of any bones in the foot or ankle
7. Pain of 8/10 or greater during walking
8. Uncorrected visual or hearing impairments
9. Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
10. Pregnancy
11. Body mass index greater than 40 kg/m2

Contacts and Locations

Study Contact

Jason M Wilken, PT, PhD

CONTACT

3193356857

jason-wilken@uiowa.edu

Kirsten M Anderson, BSE

CONTACT

3193530431

kirsten-m-anderson@uiowa.edu

Principal Investigator

Jason M Wilken, PT,PhD

PRINCIPAL_INVESTIGATOR

University of Iowa

Study Locations (Sites)

University of Iowa

Iowa City, Iowa, 52242

United States

Collaborators and Investigators

Sponsor: University of Iowa

Jason M Wilken, PT,PhD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-16

Study Completion Date2025-09-01

Study Record Updates

Study Start Date2024-08-16

Study Completion Date2025-09-01

Terms related to this study

Keywords Provided by Researchers

Plantar Force
Ankle Foot Orthosis
Carbon Fiber Orthosis
Biomechanics

Additional Relevant MeSH Terms

Traumatic Lower Limb Injury