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Impact of Sensor Technology in Knee OA
N/A
Waitlist Available
Led By Prakash Jayabalan, MD, PhD
Research Sponsored by OPUM Technologies US LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a special knee brace with a tracking device for people with knee osteoarthritis. The device monitors knee movements and activities, sending data to a mobile phone for real-time monitoring. This aims to reduce pain and improve quality of life by making exercise programs more effective and convenient. Braces designed to unload the more diseased part of the knee have been used to provide relief from osteoarthritis.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
Secondary study objectives
5 times sit-to-stand
Condition Improvement
Digital Knee Data (for intervention group)
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 2. Intervention group: Medial off-loader brace with OPUM Digital Knee and Remote Patient MonitoringExperimental Treatment1 Intervention
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.
Group II: Control group: Medial off-loader brace and home exercise programActive Control1 Intervention
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.
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Who is running the clinical trial?
OPUM Technologies US LTDLead Sponsor
Shirley Ryan AbilityLabOTHER
208 Previous Clinical Trials
17,937 Total Patients Enrolled
3 Trials studying Osteoarthritis
103 Patients Enrolled for Osteoarthritis
Prakash Jayabalan, MD, PhDPrincipal InvestigatorShirley Ryan AbilityLab; Northwestern University Feinberg School of Medicine
3 Previous Clinical Trials
103 Total Patients Enrolled
3 Trials studying Osteoarthritis
103 Patients Enrolled for Osteoarthritis