CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Malleo-Lokdevice
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/NCT04806100
NCT04806100N/ACompleted

Effects of Malleo-Lok Stiffness on Lower Limb Mechanics

University of Iowa·interventional·Posted Mar 19, 2021·Updated Jun 15, 2023

In Brief

A clinical study evaluating Malleo-Lok for Adult ALL and Healthy. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 19, 2021
Enrollment StartMar 11, 2021
Primary CompletionOct 20, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.3 years ago

Interventions

Malleo-Lokdevice

The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane.