Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT06127264
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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

Primary Outcome Measure

Proximal Cuff Force [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52241
Jason M Wilken, PT, PhD
[email protected]
3193356857
Kirsten M Anderson, PhD
[email protected]
3193530431

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By research site
University of Iowa· Iowa City, IA

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