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Not listed Not applicable Interventional

Impact of Sensor Technology in Knee OA

ClinicalTrials.gov ID: NCT05222503

Public ClinicalTrials.gov record NCT05222503. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

The Impact of Sensor Technology in Individuals With Knee OA

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

OBJECTIVES: Physical activity has been established as an important component of rehabilitation for knee osteoarthritis (OA), and is often guided by a physical therapist.(1) Physical therapy for knee OA typically involves 1-3 sessions with a licensed physical therapist per week, for up to 12 weeks. These sessions can take a lot of time and effort for subjects, particularly when travel times are considered. Remote patient monitoring is an emerging treatment method which can help to reduce the need for in-person treatment sessions. Remote patient monitoring has been tested in subjects after a total knee arthroplasty, and initial results show that subjects find the process motivating and engaging.(2) This process has not been tested in individuals with symptomatic knee OA. Prior studies have shown that personalized internet based programs are effective at improving function in individuals with knee OA(3), but the effectiveness of these programs with remote patient monitoring is unknown. One example of current wearable technology that can be utilized for remote patient monitoring is the Opum (OPUM) Digital Knee® (ODK) modular orthotic. The ODK utilizes a wearable device in a knee brace which relays real time information back to the subject and physical therapist via their mobile phone. The ODK can provide information about sagittal and frontal plane knee kinematics, sagittal plane knee range of motion, time spent performing various daily activities, time spent exercising, overall load on the knee joint, and progress over time in each of these metrics. This device has been previously tested in subjects after an ACL reconstruction, but has yet to be tested in subjects with knee osteoarthritis. The objective of this study is to assess the effect of the ODK technology in a medial knee unloader brace with remote patient monitoring on pain, function, and quality of life in individuals with knee OA. This study will contain two groups: A control group receiving a medial unloader brace and a personalized home exercise program, and an intervention group which will receive an ODK in a medial off-loader brace, and a home exercise program with remote patient monitoring. The hypothesis is that subjects who wear the knee brace with the ODK with remote patient monitoring will have a greater reduction in pain and increase in quality of life than those who receive the brace with a home exercise program.

Study identification

NCT ID
NCT05222503
Recruitment status
Not listed
Study type
Interventional
Phase
Not applicable
Lead sponsor
OPUM Technologies US LTD
Other
Enrollment
60 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
40 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 18, 2021
Primary completion
May 30, 2022
Completion
Jul 13, 2022
Last update posted
Feb 2, 2022

2021 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Shirley Ryan AbilityLab Chicago Illinois 60611 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05222503, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 2, 2022 · Synced Sep 5, 2026

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