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NCT05209360 · ClinicalTrials.gov registry record · NA

Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics

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

NCT05209360: Completed NA study of Healthy and Adult ALL, sponsored by University of Iowa.

NCT05209360 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. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05209360, 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 proposed study evaluates the effect of medial and lateral wedges and carbon fiber custom dynamic orthoses (CDOs) on lower limb forces and motion during walking. Previous work has used foam wedges of different stiffness and height placed under the heel to alter CDO alignment and alter lower limb mechanics. Medial or lateral wedges have been used by individuals with unilateral knee osteoarthritis in effort to reduce knee loading. In this study, medial and lateral wedges will be placed in participants shoes, with the tall side of the wedge placed on the medial or lateral aspect of the shoes, and participants will walk at controlled and self-selected speeds and complete physical performance measures. Participants will also walk without a CDO. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.

Primary Outcome

Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane knee range of motion (degrees) wa

Conditions Studied

Interventions

  • DEVICE Carbon Fiber Custom Dynamic Orthosis
  • DEVICE Medial or Lateral Wedge

Study Locations (1)

Iowa

  • University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-05-09
Est. Completion 2022-12-01
Phase NA
University of Iowa

228 total trials

What the finished NCT05209360 record still lists

NCT05209360 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Carbon Fiber Custom Dynamic Orthosis is the first listed.

NCT05209360 reports a single indexed study location in Iowa.

Frequently Asked Questions

What is clinical trial NCT05209360 about?

NCT05209360 is a clinical study titled "Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics". The proposed study evaluates the effect of medial and lateral wedges and carbon fiber custom dynamic orthoses (CDOs) on lower limb forces and motion during walking. Previous work has used foam wedges of different stiffness and height placed under the heel to alter CDO alignment and alter lower limb ...

What is the current status of trial NCT05209360?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2022-05-09. Estimated completion is 2022-12-01.

What conditions does trial NCT05209360 study?

This clinical trial studies the following conditions: Healthy, Adult ALL.

What interventions are being tested in trial NCT05209360?

The interventions under investigation include: Carbon Fiber Custom Dynamic Orthosis (DEVICE), Medial or Lateral Wedge (DEVICE).

Who is sponsoring clinical trial NCT05209360?

This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05209360 being conducted?

This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05209360's enrollment target sits among peer trials

20 861st of 1090 higher than 194 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy 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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Source: ClinicalTrials.gov NCT05209360, the US trial registry maintained by the National Library of Medicine. NCT05209360 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.