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Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

NCT06127264 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-31

No results posted yet for this study

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

Interventions

DEVICE

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

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Jason Wilken, PT,PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127264 on ClinicalTrials.gov