Remote Rehabilitation With Knee Brace for Individuals With Degenerative Joint Disease (NCT07188493) | Clinical Trial Compass
CompletedNot Applicable
Remote Rehabilitation With Knee Brace for Individuals With Degenerative Joint Disease
Poland36 participantsStarted 2024-05-31
Plain-language summary
The goal of this observational study is to learn how well remote rehabilitation and offloading the inner part of the knee joint using a custom-made knee brace work as non-surgical treatments for people with unicompartmental knee osteoarthritis.
The main question it aims to answer is:
Does the remote rehabilitation system improve symptoms and function in people with knee osteoarthritis?
Researchers will compare three groups of participants to see how different types of knee braces and rehabilitation methods affect outcomes:
Group A will use a custom-made knee brace connected to a mobile app and motion sensors.
Group B will use a custom-made knee brace daily and perform prescribed exercises.
Group C will use a standard off-the-shelf functional knee brace daily and perform the same prescribed exercises.
Participants will:
Wear their assigned brace for 6 months
Complete surveys (VAS, KOOS, and Laitinen)
Have their knee range of motion and body weight measured
Who can participate
Age range
45 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unicompartmental knee osteoarthritis (medial compartment), Kellgren-Lawrence grade I-III, confirmed by imaging; affecting one lower limb (with predominant symptoms in either the right or left leg)
* Age between 45 and 75 years
* Preserved passive knee extension; flexion contracture of up to 20 degrees of extension deficit is acceptable
* Signed informed consent for participation in the clinical investigation
Exclusion Criteria:
* Bicompartmental knee osteoarthritis with similar symptom severity in both compartments
* Neurological disorders
* Rheumatoid arthritis
* Coexisting dysfunctions of the hip and/or ankle joint of the affected limb
* Ligament injuries (ACL, PCL, MCL, LCL) and/or meniscus injuries (medial or lateral) causing significant joint instability (moderate instability due to ligament insufficiency, common in osteoarthritis, is not excluded)
* Bone fractures
* Sensory disturbances in the lower limbs
* Passive knee extension deficit greater than 20 degrees
* Major surgical procedures involving the knee joint within the last 6 months
* Lack of informed consent and/or inability to establish reliable verbal-logical communication with the participant
* Other medical conditions preventing independent application of the brace and/or use of the mobile application
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score)