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Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

University of Iowa · NCT06127264

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–90 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
March 1, 2024
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Carbon Fiber Custom Dynamic Orthosis (CDO)

Conditions: Healthy; Ankle Foot Orthosis (AFO); Peripheral Neuropathy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Group 1 - Able Bodied Participants

Inclusion Criteria

  • Between the ages of 18 and 65
  • Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
  • Able to hop without pain
  • Able to perform a full squat without pain
  • Ability to read and write in English and provide written informed consent
  • Ability to fit in a generic sized CDO

Exclusion Criteria

  • Diagnosed with a moderate or severe brain injury
  • Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
  • Injuries that would limit performance in this study
  • Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
  • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
  • Require use of an assistive device
  • Unhealed wounds (cuts/abrasions) that would prevent AFO use
  • BMI > 40
  • Pregnancy

Group 2 - AFO Users without Peripheral Neuropathy

Inclusion Criteria

  • Between the ages of 18 and 90
  • Use an AFO(s) for daily activities
  • The AFO(s) proximal cuff is compatible with loadpad sensors
  • Have used their AFO(s) for a minimum of 2 weeks
  • Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
  • Ability to read and write in English and provide written informed consent

Exclusion Criteria

  • Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
  • Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
  • Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
  • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
  • BMI > 40
  • Pregnancy

Group 3 - AFO Users with Peripheral Neuropathy

Inclusion Criteria

  • Between the ages of 18 and 90
  • Use an AFO(s) for daily activities
  • The AFO(s) proximal cuff is compatible with loadpad sensors
  • Have used their AFO(s) for a minimum of 2 weeks
  • Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
  • Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
  • Ability to read and write in English and provide written informed consent

Exclusion Criteria

  • Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
  • Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
  • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
  • BMI > 40
  • Pregnancy

Recruiting US locations

  • University of Iowa

    Iowa City, IA 52241

    Site contact: Jason M Wilken, PT, PhD · 3193356857 · jason-wilken@uiowa.edu

Study contacts (from the official record)

  • Jason M Wilken, PT, PhD · 3193356857 · jason-wilken@uiowa.edu
  • Kirsten M Anderson, PhD · 3193530431 · kirsten-m-anderson@uiowa.edu
All neurology studies in Iowa →
Reliability of Force Measurement Within the Carbon Fiber Orthosis… (NCT06127264) | Bored Studies