Clinical trial NCT05222503: Impact of Sensor Technology in Knee OA
Official title: The Impact of Sensor Technology in Individuals With Knee OA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
knee
orthotics
remote patient monitoring
wearable technology
brace
Lead sponsor: OPUM Technologies US LTD
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
First posted: 2022-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
timeFrame: 12 weeks from onset of brace wearing
Secondary outcomes:
measure: Symptoms
timeFrame: 12 weeks from onset of brace wearing
measure: Function
timeFrame: 12 weeks from onset of brace wearing
measure: Impact of Osteoarthritis on Quality of Life
timeFrame: 12 weeks from onset of brace wearing
measure: Quality of life measured using the EQ5D survey
timeFrame: 12 weeks from onset of brace wearing
measure: Walking speed
timeFrame: 12 weeks from onset of brace wearing
measure: Walking endurance
timeFrame: 12 weeks from onset of brace wearing
measure: Stair negotiation
timeFrame: 12 weeks from onset of brace wearing
measure: 5 times sit-to-stand
timeFrame: 12 weeks from onset of brace wearing
measure: Patient diary
timeFrame: 12 weeks
measure: Digital Knee Data (for intervention group)
timeFrame: 12 weeks
measure: Patient satisfaction
timeFrame: At 12-week follow-up visit
measure: System Usability Scale (for intervention group)
timeFrame: At 12-week follow-up visit
measure: Condition Improvement
timeFrame: At 12-week follow-up visit
measure: Need for medication to treat osteoarthritis symptoms
timeFrame: At 12-week follow-up visit
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab; Northwestern University Feinberg School of Medicine
name: Prakash Jayabalan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
citation: Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.
citation: Ramkumar PN, Haeberle HS, Ramanathan D, Cantrell WA, Navarro SM, Mont MA, Bloomfield M, Patterson BM. Remote Patient Monitoring Using Mobile Health for Total Knee Arthroplasty: Validation of a Wearable and Machine Learning-Based Surveillance Platform. J Arthroplasty. 2019 Oct;34(10):2253-2259. doi: 10.1016/j.arth.2019.05.021. Epub 2019 May 16.
citation: Bosomworth NJ. Exercise and knee osteoarthritis: benefit or hazard? Can Fam Physician. 2009 Sep;55(9):871-8.
citation: Kanavaki AM, Rushton A, Efstathiou N, Alrushud A, Klocke R, Abhishek A, Duda JL. Barriers and facilitators of physical activity in knee and hip osteoarthritis: a systematic review of qualitative evidence. BMJ Open. 2017 Dec 26;7(12):e017042. doi: 10.1136/bmjopen-2017-017042.