Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

Study acronym: CuffForce
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
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Record History

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  1. Notable Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2027
    • Eligibility criteria expanded, about 39 words
  2. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Site contact updated
    v6
  3. Notable Primary completion date: Jun 2025 to Dec 31, 2025
    • Study completion date: Dec 2025 to Dec 31, 2026
    • Site contact updated
    v5
  4. Notable Enrollment target: 40 to 60
    • Eligibility criteria expanded, about 165 words
    v4
  5. Notable Enrollment target: 20 to 40
    • Primary completion date: Jan 2025 to Jun 2025
    • Study completion date: May 2025 to Dec 2025
    • Eligibility criteria expanded, about 121 words
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2024 to Mar 1, 2024
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06127264
Lead Sponsor University of Iowa
Conditions
(from sponsor)
Healthy, Ankle Foot Orthosis (AFO), Peripheral Neuropathy
Related terms Peripheral Nervous System Diseases
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov