Using Pressure Detecting Insoles to Reduce Knee Loading
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|ClinicalTrials.gov Identifier: NCT02955225|
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: Active Moticon OpenGO insole Device: Passive shoe insole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Using Pressure Detecting Insoles to Reduce Knee Loading and Improve Function|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: Flexible shoe with Active Insole
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Device: Active Moticon OpenGO insole
A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
Active Comparator: Flexible shoe with Passive Insole
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Device: Passive shoe insole
A deactivated insole measures shoe pressure only.
- Change in Knee adduction moment [ Time Frame: Baseline, 3 weeks, 6 weeks ]Surrogate marker of medial knee loading
- Change in knee pain [ Time Frame: Baseline, 3 weeks, 6 weeks ]Visual analog scale
- Change in spatiotemporal parameters [ Time Frame: Baseline, 3 weeks, 6 weeks ]Speed
- Change in self-reported Functional status [ Time Frame: Baseline, 3 weeks, 6 weeks ]Knee injury and Osteoarthritis Outcome Score
- Change in other knee loading parameters [ Time Frame: Baseline, 3 weeks, 6 weeks ]Knee Flexion moment and other external moments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955225
|Contact: Chris Ferrigno, PhDemail@example.com|
|Contact: Philip Malloy, MPTfirstname.lastname@example.org|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Markus A Wimmer, PhD 312-942-2789 email@example.com|
|Contact: Christopher Ferrigno, PhD 3125633868 firstname.lastname@example.org|
|Sub-Investigator: Najia Shakoor, MD|
|Principal Investigator:||Markus Wimmer, PhD||Rush University Medical Center|