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NCT06127316 · ClinicalTrials.gov registry record · NA
The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses
A NA study of Traumatic Lower Limb Injury, sponsored by University of Iowa.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06127316: Recruiting NA study of Traumatic Lower Limb Injury, sponsored by University of Iowa.
NCT06127316 is a NA study of Traumatic Lower Limb Injury that is actively recruiting participants, run by University of Iowa. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06127316, a NA study of Traumatic Lower Limb Injury, is actively recruiting participants, sponsored by University of Iowa.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.
Primary Outcome
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
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 | 20 participants |
| Start Date | 2024-08-16 |
| Est. Completion | 2026-06-01 |
| Phase | NA |
What NCT06127316 shows while recruiting
NCT06127316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Traumatic Lower Limb Injury appearing as the primary indexed condition, and to 1 intervention - of which Carbon Fiber Custom Dynamic Orthosis (CDO) is the first listed.
NCT06127316 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT06127316 about?
NCT06127316 is a clinical study titled "The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses". Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different region...
What is the current status of trial NCT06127316?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-08-16. Estimated completion is 2026-06-01.
What conditions does trial NCT06127316 study?
This clinical trial studies the following conditions: Traumatic Lower Limb Injury.
What interventions are being tested in trial NCT06127316?
The interventions under investigation include: Carbon Fiber Custom Dynamic Orthosis (CDO) (DEVICE).
Who is sponsoring clinical trial NCT06127316?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06127316 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06127316's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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