Impact of Sensor Technology in Knee OA
The Impact of Sensor Technology in Individuals With Knee OA
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2021
CompletedFirst Submitted
Initial submission to the registry
January 7, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2022
CompletedFebruary 3, 2022
January 1, 2022
10 months
January 7, 2022
January 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
Measured by the Knee injury and osteoarthritis score subscale (KOOS subscales) as a comparison between both groups of the evolution of pain between Day 0 and Week 12.
12 weeks from onset of brace wearing
Secondary Outcomes (14)
Symptoms
12 weeks from onset of brace wearing
Function
12 weeks from onset of brace wearing
Impact of Osteoarthritis on Quality of Life
12 weeks from onset of brace wearing
Quality of life measured using the EQ5D survey
12 weeks from onset of brace wearing
Walking speed
12 weeks from onset of brace wearing
- +9 more secondary outcomes
Study Arms (2)
Control group: Medial off-loader brace and home exercise program
ACTIVE COMPARATORThe 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.
2. Intervention group: Medial off-loader brace with OPUM Digital Knee and Remote Patient Monitoring
EXPERIMENTALThe 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.
Interventions
Knee Brace + OPUM Digital Knee
Knee Brace without OPUM Digital Knee
Eligibility Criteria
You may qualify if:
- Pain score \> 12.5 KOOS
- BMI \< 35
- Own a compatible mobile phone?
- Able to operate Bluetooth technology?
- Diagnosis of unilateral femoro-tibial knee OA
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OPUM Technologies US LTDlead
- Shirley Ryan AbilityLabcollaborator
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
Related Publications (5)
Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.
PMID: 20699159BACKGROUNDBhatia 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.
PMID: 23559821RESULTRamkumar 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.
PMID: 31128890RESULTBosomworth NJ. Exercise and knee osteoarthritis: benefit or hazard? Can Fam Physician. 2009 Sep;55(9):871-8.
PMID: 19752252RESULTKanavaki 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.
PMID: 29282257RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prakash Jayabalan, MD, PhD
Shirley Ryan AbilityLab; Northwestern University Feinberg School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2022
First Posted
February 3, 2022
Study Start
August 19, 2021
Primary Completion
May 31, 2022
Study Completion
July 14, 2022
Last Updated
February 3, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share