Recruiting

Sensor Technology

Sponsor:

OPUM Technologies US LTD

Code:

NCT05222503

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Knee Brace + OPUM Digital Knee

Knee Brace

Study Details

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 KneeĀ® (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.

Conditions

Knee Osteoarthritis

Study ID

NCT05222503

Start date

Aug 19, 2021

Status verified date

Jan, 2022

Completion date

Jul 14, 2022

Anticipated

Primary completion date

May 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

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

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.

Interventions

Knee Brace + OPUM Digital Knee

Knee Brace + OPUM Digital Knee

Knee Brace

Knee Brace without OPUM Digital Knee

Primary outcome measure

  • Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey) [ Time Frame: 12 weeks from onset of brace wearing ]

Central Contacts and Locations

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Prakash Jayabalan, MD, PhD

More Information

Sponsor

OPUM Technologies US LTD

Last update posted

Feb 3, 2022

Last verified

Jan, 2022

Keywords

  • osteoarthritis
  • knee
  • orthotics
  • remote patient monitoring
  • wearable technology
  • brace

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OPUM Technologies US LTD on 2022-02-03.