RECRUITING

Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

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

The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN). An improved understanding of the forces acting within orthoses may help to guide future orthosis related research studies, provision methods, and patient education. Study participants will consist of three groups; 1) healthy, able-bodied adult participants using generic sized CDOs, which consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy, and a semi-rigid footplate that acts as a lever arm to bend the posterior strut, 2) individuals without peripheral neuropathy who use AFO(s) regularly, and 3) individuals with peripheral neuropathy who use AFO(s) regularly. . Group 1 participants will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; 'Loose' where the proximal cuff is loosely fastened around the participants leg, 'Moderate' where the proximal cuff is fastened with moderate tightness, and 'Tight' where the proximal cuff is tightly fastened around the participants leg. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order. Group 2 and Group 3 participants will be asked to fasten their AFO(s) to a self-selected 'SSCT' tightness. For all groups, forces acting on the leg, within the proximal cuff, will be measured using wireless Loadpad sensors and forces acting on the foot will be measured using wireless Loadsol insoles. Testing will include collection of force data as participants sit quietly, stand quietly, and walk and completion of questionnaires.

Official Title

Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

Quick Facts

Study Start:2024-03-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06127264

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 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 18 and 90
  2. * Use an AFO(s) for daily activities
  3. * The AFO(s) proximal cuff is compatible with loadpad sensors
  4. * Have used their AFO(s) for a minimum of 2 weeks
  5. * Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
  6. * Ability to read and write in English and provide written informed consent
  7. * Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
  8. * Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
  9. * Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
  10. * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
  11. * BMI \> 40
  12. * Pregnancy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

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 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 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 Date2024-03-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Ankle Foot Orthosis
  • Carbon Fiber Orthosis
  • Plantar Force

Additional Relevant MeSH Terms

  • Healthy
  • Ankle Foot Orthosis (AFO)
  • Peripheral Neuropathy