Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||40 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Rush University Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Markus Wimmer, PhD|
|Principal Investigator Affiliation||Rush University Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
This is a randomized longitudinal proof-of-concept study. After a telephone prescreening, an in-person visit will screen for inclusion and exclusion criteria, requiring a clinical and radiographic assessment. A total of 40 subjects with symptomatic and radiographic medial knee OA will be enrolled in the study after obtaining informed consent. A total of three study visits will occur at the following time points: baseline, 3 weeks, and 6 weeks. At all three visits, the following outcome variables will be acquired:
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).
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: - Active Moticon OpenGO insole
A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
Device: - Passive shoe insole
A deactivated insole measures shoe pressure only.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.