COMPLETED

Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics

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) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.

Official Title

Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics

Quick Facts

Study Start:2023-05-17
Study Completion:2025-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05456295

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages 18-65.
  2. 2. Diagnosis of ankle PTOA.
  3. 3. Ability to walk 50 feet at a slow to moderate pace.
  4. 4. Ability to walk without a cane or crutch.
  5. 5. Ability to read and write in English and provide written informed consent.
  1. 1. Diagnosis with a moderate or severe brain injury.
  2. 2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition…).
  3. 3. Ankle weakness as a result of spinal cord injury or nervous system pathology.
  4. 4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity.
  5. 5. Rheumatoid or inflammatory arthritis.
  6. 6. Necrosis of any bones in the foot or ankle.
  7. 7. Pain of 8/10 or greater during walking.
  8. 8. Surgery on study limb anticipated in the next 6 months.
  9. 9. Uncorrected visual or hearing impairments.
  10. 10. Require use of a stabilizing device (i.e. Ankle Foot Orthosis or Knee Orthosis…) to perform daily activities.
  11. 11. Pregnancy
  12. 12. Body mass index greater than 40.

Contacts and Locations

Principal Investigator

Jason M Wilken, PT, PhD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa
Iowa City, Iowa, 52241
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 Date2023-05-17
Study Completion Date2025-09-29

Study Record Updates

Study Start Date2023-05-17
Study Completion Date2025-09-29

Terms related to this study

Keywords Provided by Researchers

  • Gait Analysis
  • Ankle Foot Orthosis
  • Carbon Fiber
  • Biomechanics
  • Adult
  • Arthritis
  • Healthy

Additional Relevant MeSH Terms

  • Healthy
  • Lower Limb Injury
  • Post-Traumatic Osteoarthritis