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NCT04806100 · ClinicalTrials.gov registry record · NA
Effects of Malleo-Lok Stiffness on Lower Limb Mechanics
A NA study of Healthy and Adult ALL, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04806100 is a NA study of Healthy and Adult ALL that has completed, run by University of Iowa. The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04806100, a NA study of Healthy and Adult ALL, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this research study is to determine if the stiffness of a commercially available ankle foot orthosis (Malleo-Lok, Bio-Mechanical Composites, Des Moines IA) impacts gait biomechanics and overall joint level stiffness. Previously published research suggests that AFO stiffness can affect gait biomechanics and patient preference. However, previous studies have focused on traditional posterior strut devices with the strut aligned in the frontal plane to allow sagittal plane deflection. The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane. The proposed study will provide insight that can be used by certified prosthetists orthotists (CPOs), physical therapists, and physicians to select the device that bests meets their patients' needs.
Interventions
- DEVICE Malleo-Lok
Study Locations (1)
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-03-11 |
| Est. Completion | 2021-10-20 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04806100
The ClinicalTrials.gov registry entry for NCT04806100 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 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 (97% lower). The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Malleo-Lok is the first listed.
NCT04806100 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT04806100 about?
NCT04806100 is a clinical study titled "Effects of Malleo-Lok Stiffness on Lower Limb Mechanics". The primary purpose of this research study is to determine if the stiffness of a commercially available ankle foot orthosis (Malleo-Lok, Bio-Mechanical Composites, Des Moines IA) impacts gait biomechanics and overall joint level stiffness. Previously published research suggests that AFO stiffness ca...
What is the current status of trial NCT04806100?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2021-03-11. Estimated completion is 2021-10-20.
What conditions does trial NCT04806100 study?
This clinical trial studies the following conditions: Healthy, Adult ALL.
What interventions are being tested in trial NCT04806100?
The interventions under investigation include: Malleo-Lok (DEVICE).
Who is sponsoring clinical trial NCT04806100?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04806100 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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