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NCT06127264 · ClinicalTrials.gov registry record · NA
Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff
A NA study of Healthy and Peripheral Neuropathy, sponsored by University of Iowa.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06127264 is a NA study of Healthy and Peripheral Neuropathy that is actively recruiting participants, run by University of Iowa. The registered enrollment target is 60 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06127264, a NA study of Healthy and Peripheral Neuropathy, is actively recruiting participants, sponsored by University of Iowa.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE Carbon Fiber Custom Dynamic Orthosis (CDO)
Study Locations (1)
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06127264
The ClinicalTrials.gov registry entry for NCT06127264 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Carbon Fiber Custom Dynamic Orthosis (CDO) is the first listed.
NCT06127264 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT06127264 about?
NCT06127264 is a clinical study titled "Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff". 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...
What is the current status of trial NCT06127264?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-03-01. Estimated completion is 2026-12-31.
What conditions does trial NCT06127264 study?
This clinical trial studies the following conditions: Healthy, Peripheral Neuropathy, Ankle Foot Orthosis (AFO).
What interventions are being tested in trial NCT06127264?
The interventions under investigation include: Carbon Fiber Custom Dynamic Orthosis (CDO) (DEVICE).
Who is sponsoring clinical trial NCT06127264?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06127264 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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