Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

NCT06127264 | Recruiting FDA Device

• 1 other identifier: 202212359
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Ankle Foot Orthosis (AFO); Peripheral Neuropathy; Healthy

Keywords

Ankle Foot Orthosis; Carbon Fiber Orthosis; Plantar Force

Outcome Measures

Primary Outcomes (5)

• Proximal Cuff Force

  Proximal cuff forces (N) will be measured as participants sit, stand, and walk without a CDO and in each CDO condition.

  Baseline

• Peak Plantar Force

  Plantar forces (N) will be measured across the total foot, the hindfoot, midfoot, and forefoot as participants sit, stand, and walk without a CDO and in each CDO condition.

  Baseline

• Plantar Force Impulse

  Plantar force impulse (Ns) across the total foot, the hindfoot, midfoot, and forefoot will be calculated using the integral of the force over the stance phase as participants sit, stand, and walk without a CDO and in each CDO condition.

  Baseline

• Numerical Pain Rating Scale

  Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable

  Baseline

• Modified Socket Comfort Score (Comfort)

  Comfort scores range from 0 = most uncomfortable to 10 = most comfortable

  Baseline

Secondary Outcomes (1)

• Modified Socket Comfort Score (Smoothness)

  Baseline

Study Arms (5)

NoCDO

NO INTERVENTION

Participants will complete study activities without wearing a CDO

SSCT

EXPERIMENTAL

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

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Loose

EXPERIMENTAL

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

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Moderate

EXPERIMENTAL

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

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Tight

EXPERIMENTAL

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

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO) DEVICE

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

Also known as: Ankle Foot Orthosis (AFO)

Loose; Moderate; SSCT; Tight

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jason Wilken, PT,PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason M Wilken, PT, PhD

CONTACT

3193356857; jason-wilken@uiowa.edu

Kirsten M Anderson, PhD

CONTACT

3193530431; kirsten-m-anderson@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded, to the greatest extent possible, to the different CDO proximal cuff tightness's.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants in Group 1 will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; Loose, Moderate, and Tight. Participants in Group 2 and Group 3 will only be asked to fasten their AFO(s) to a self-selected tightness. Testing will occur without a CDO (NoCDO) and with each cuff tightness (SSCT, Loose, Moderate, Tight). Forces acting on the leg will be measured using wireless Loadpad sensors and forces acting on the plantar surface of 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. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)