CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Medial or Lateral Wedge +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05209360
NCT05209360N/ACompleted

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

University of Iowa·interventional·Posted Jan 26, 2022·Updated Jan 30, 2024

In Brief

A clinical study evaluating Medial or Lateral Wedge and Carbon Fiber Custom Dynamic Orthosis for Adult ALL and Healthy. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult ALL, Healthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 26, 2022
Enrollment StartMay 9, 2022
Primary CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.4 years ago

Interventions

Medial or Lateral Wedgedevice

A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.

Carbon Fiber Custom Dynamic Orthosisdevice

A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.