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| Name | Class |
|---|---|
| Sporto Clinic | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Participants in this group follow a complete telerehabilitation protocol, including:
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| Group B | Participants in this group receive:
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| Group C | Participants in this group receive:
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| Measure | Description | Time Frame |
|---|---|---|
| KOOS Questionnaire (Knee injury and Osteoarthritis Outcome Score) | The KOOS questionnaire is a validated and internationally recognized self-reported tool, officially translated into Polish, used to assess knee-related symptoms. It consists of five subscales: pain, knee stiffness, daily living function, sports and recreational activity, and knee-related quality of life. The maximum score of 100 indicates no symptoms or limitations, while a score of 0 indicates extreme symptom severity. | At first and final visit (6 months) |
| VAS Scale (Visual Analog Scale) | A subjective scale for evaluating pain intensity. This 10-point scale measures how strong the participant's pain is, where 1 means no pain and 10 means unbearable pain. | At first and final visit (6 months) |
| Laitinen Scale | A subjective, point-based tool assessing pain based on four features: intensity, frequency, use of pain medication, and physical activity limitation. Each category is scored from 0 to 4, where 0 means no issue, and 4 indicates the most severe problem. | At first and final visit (6 months) |
| Lower Limb Ortogram | Anteroposterior (AP) radiograph of both lower limbs taken in a standing position, with feet hip-width apart and in a neutral position. Measurements include the angle between the mechanical axis of the femur and tibia, and the medial joint space width (JSW) of the knee [mm]. | At first and final visit (6 months) |
| Range of Motion (ROM) of the Knee Joint | Angular measurement of the knee's flexion and extension using an electronic goniometer. For flexion: the patient lies on their back with legs extended; the goniometer axis is placed at the lateral femoral epicondyle, with the fixed arm aligned with the greater trochanter and the movable arm following the lateral malleolus as the patient actively bends the knee. For extension: the patient lies face down with legs bent at the knees, positioned so that the knees extend beyond the edge of the examination table to allow full extension or hyperextension. Goniometer placement follows the same protocol. Measurements are taken for both limbs. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI (Body Mass Index) | BMI is calculated as weight [kg] divided by height squared [m²]. It is considered a significant risk factor in the severity and progression of knee osteoarthritis. A simplified BMI classification is used in this study: <18.5 - underweight; 18.5-24.99 - normal; >24.99 - overweight | At first and final visit (6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be observed from patients receiving conservative treatment for medial compartment knee osteoarthritis at the Sporto Clinic. The study population includes adults aged 45 to 75 years diagnosed with unicompartmental knee osteoarthritis (Kellgren-Lawrence grade I-III) in one lower limb, confirmed by imaging. Participants are community-dwelling individuals able to follow a home-based exercise program and use a functional knee brace.
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| Name | Affiliation | Role |
|---|---|---|
| Marcin Domżalski, M.D. | Sporto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sporto | Lodz | 90-038 | Poland |
Individual participant data (IPD) will not be shared because the study involves a small, single-center population, and the data include potentially identifiable medical and imaging information. The data are intended for internal analysis and publication in aggregate form only.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| At first and final visit (6 months) |
| Custom Satisfaction Questionnaire | A proprietary survey assessing patient satisfaction with the telerehabilitation program, as well as comfort and perceived effectiveness of the cage-type knee brace used in the conservative treatment of knee osteoarthritis. The survey is based on a 5-point scale, where 1 represents a poor outcome, 5 indicates an excellent result, and 3 denotes no change. | At the final visit (6 months) |
| Lower Limb Circumference Measurements | Circumference measurements (in cm) of the thigh (10 cm above mid-patella), knee (at mid-patella), and calf (15 cm below mid-patella) on both braced and non-braced limb; used for asymmetry assessment, monitoring changes over time, and brace sizing. | At first and final visit (6 months) |