Impact of Sensor Technology in Knee OA

OPUM Technologies

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Device: Knee Brace + OPUM Digital Knee; Device: Knee Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT05222503

STU00214887

Details and patient eligibility

About

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.

Full description

BACKGROUND:

Knee osteoarthritis (OA) is a significant problem in the adult population. With a prevalence of 10-13% in individuals over age 60,(4) knee OA results in a significant reduction in quality of life and increased economic costs to both the individual with knee OA and the medical system as a whole.

Exercise is a key component of management of knee OA, resulting in decreased pain and increased function.(3) Potential barriers to exercise in subjects with knee OA is lack of motivation or professional support.(5) Both of these barriers can be addressed with remote patient monitoring. Remote patient monitoring will allow a physical therapist to monitor the activity levels and progress of each subject, and make adjustments throughout the duration the rehab program.

Wearable technology has begun to disrupt conventional methods of healthcare delivery. Wearable technology can allow for remote patient monitoring and self monitoring for subjects with OA. The ODK is a novel wearable device which has previously been tested in subjects with anterior cruciate ligament (ACL) reconstructions, but has not yet been tested in individuals with knee OA. The ODK allows for tracking of knee range of motion, frontal plane kinematics, sagittal plane kinematics, exercise progress, time spent walking/standing/sitting/kneeling, and time spent sedentary. These measures can help to provide useful information to the patient on potential mitigating factors in their knee OA and provide real time feedback about joint kinematics.

This study will investigate the effects of the ODK used in a medial off-loader brace with remote patient monitoring. This randomized control trial will have 2 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. These subjects will be followed for 12 weeks and assessed for changes in pain, function, and quality of life.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pain score > 12.5 KOOS
• BMI < 35
• Own a compatible mobile phone?
• Able to operate Bluetooth technology?
• Diagnosis of unilateral femoro-tibial knee OA

Exclusion criteria

• History of lower extremity total joint arthroplasty? (in affected knee)
• Current uncontrolled cardiovascular disease?
• Other pathology? Ex: Parkinson's, stroke, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or other knee diseases (Paget, osteonecrosis, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control group: Medial off-loader brace and home exercise program

Active Comparator group

Description:

The subject will receive a traditional medial off-loader brace and a take-home, self-guided exercise program. The subject will be instructed how to wear the brace. The subject will be instructed to incrementally increase wear time of the brace in the first week to get accustomed to the brace to reach a minimum of 6 hours per day after the first week.

Treatment:

Device: Knee Brace

2. Intervention group: Medial off-loader brace with OPUM Digital Knee and Remote Patient Monitoring

Experimental group

Description:

The same off-loader brace as above but with the ODK sensor will be provided. The subject will be instructed how to wear the brace and sensor. The patient will be instructed to incrementally increase wear time in the first week to get accustomed to the brace to reach a minimum of 6 hours per day after the first week. Using the sensor they will be able to keep track of their exercise frequency, range of motion (ROM), and kinematics in the OPUM app on their mobile phone. Education/resources will also be provided to the subjects via modules in the mobile app. The subjects will be instructed how to use the app as well. Patients data will be monitored remotely for 20mins per patient per month in the sensor group. Programs will be updated as necessary based on data.

Treatment:

Device: Knee Brace + OPUM Digital Knee