Recruiting

Observational Study

Sponsor:

University of Iowa

Code:

NCT06127264

Conditions

Healthy

Ankle Foot Orthosis (AFO)

Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO)

Study Details

Brief summary:

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.

Conditions

Healthy

Ankle Foot Orthosis (AFO)

Peripheral Neuropathy

Study ID

NCT06127264

Start date

Mar 1, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: NoCDO

Participants will complete study activities without wearing a CDO

experimental: SSCT

Participants will complete study activities while wearing a CDO fastened to their self-selected proximal cuff tightness

experimental: Loose

Participants will complete study activities while wearing a CDO fastened to a loose proximal cuff tightness

experimental: Moderate

Participants will complete study activities while wearing a CDO fastened to a moderate proximal cuff tightness

experimental: Tight

Participants will complete study activities while wearing a CDO fastened to a tight proximal cuff tightness

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO)

The carbon fiber custom dynamic orthosis (CDO) will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee that is fastened to different tightness's

Primary outcome measure

  • Proximal Cuff Force [ Time Frame: Baseline ]
  • Peak Plantar Force [ Time Frame: Baseline ]
  • Plantar Force Impulse [ Time Frame: Baseline ]
  • Numerical Pain Rating Scale [ Time Frame: Baseline ]
  • Modified Socket Comfort Score (Comfort) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52241

Contacts

More Information

Sponsor

University of Iowa

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

  • Ankle Foot Orthosis
  • Carbon Fiber Orthosis
  • Plantar Force

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-12-31.