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Patient Recruitment and Enrolment
All patients diagnosed with knee OA who present at Artros Medical Center for an orthopaedic specialist consultation will undergo a radiological examination. Based on the radiographic findings and clinical evaluation, the orthopaedic specialist will refer eligible patients to a physiotherapist, who will assign them to the TG or CG. The physiotherapist will provide both verbal and written explanations of the study procedures. Patients will be included in the study after providing written informed consent.
Baseline Assessments
The physiotherapist will collect baseline data, including: Sociodemographic characteristics, Anthropometric measurements: height (cm), weight (kg), body mass index (BMI) (kg/m²), Educational background and employment status, Knee joint mobility assessment using a goniometer, Pain intensity measurement using the Numerical Rating Scale (NRS), Physical function, stiffness, and pain assessment using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Physical activity evaluation using the International Physical Activity Questionnaire (IPAQ), Health-related quality of life assessment using the 12-Item Short Form Health Survey (SF-12), OA severity classification based on recent knee radiographs (≤ 4 months old), graded using the Kellgren-Lawrence classification system.
Osteoarthritis (OA) of the knee is a chronic degenerative disease that affects the articular cartilage, causing pain, reduced mobility and reduced quality of life. Early detection and appropriate treatment are key to reducing symptoms and slowing disease progression. This study aims to evaluate the effectiveness of therapeutic interventions in patients with knee OA treated at the Artros Medical Centre.
Patients diagnosed with OA of the knee who visit the Artros Medical Centre for a consultation with an orthopaedic specialist will be included in the study. After the visit, they will undergo a radiological examination, based on which the orthopaedic surgeon will assess the severity of the disease. The specialist will then refer suitable patients to a physiotherapist who will further assess them and assign them to a telerehabilitation group (TR) or a control group (TS). The physiotherapist will provide verbal and written explanations of the study procedures to the patients.
Written informed consent will be required from each participant to participate in the study.
After inclusion in the study, the physiotherapist will collect baseline data on the patients, including the following measures:
Assessment of physical function, stiffness, and pain: The validated Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire is used.
Patients will be randomly assigned to one of two groups:
Patient measurements and assessments will be carried out at the start of the study and at specific time points (after 12 weeks). All data will be recorded and analysed to identify changes in pain, mobility, functionality, and quality of life.
Statistical analysis Data will be analysed using appropriate statistical methods (e.g., t-test, ANOVA, regression analysis). The main outcome parameters will be changes in WOMAC, NRS, IPAQ, and SF-12, where the statistical significance and clinical relevance of differences between groups will be assessed.
The Declaration of Helsinki will conduct the study, which will be subject to ethics committee approval. Before participation, all participants will be informed in detail about the nature of the study and the potential risks and benefits, and their inclusion will be voluntary.
This study will provide valuable data on the effectiveness of therapeutic interventions in patients with knee OA and will contribute to a better understanding of optimal approaches to treating this disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation Group | Experimental | Patients in the Telerehabilitation group will receive instructions on physiotherapy intervention. They will independently perform the exercise for at least three months. During this time, they will have access to continuous remote support from the physiotherapist, including: • Weekly scheduled phone consultations • Live virtual consultations via MS Teams, Zoom, or Skype • Text messages and emails for personalised guidance, motivation, and ongoing problem solving. |
|
| Control group | Active Comparator | Patients in the control group will receive only written exercise instructions and perform the rehabilitation program independently at home without additional remote supervision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Other | Telerehabilitation involves a physiotherapy program delivered remotely using digital tools. Participants perform exercises independently with remote support from a physiotherapist, including: Weekly scheduled phone consultations Live virtual consultations via MS Teams, Zoom, or Skype Text messages and emails for personalized guidance, motivation, and ongoing problem-solving The intervention includes targeted exercises for: Core muscle strength Strengthening of lower extremity muscles Mobility exercises for the hip, knee, and ankle joints Balance and stabilization exercises Each session lasts approximately 20-25 minutes, performed three times per week. Patients can choose the days for their sessions, with the requirement of a minimum of 24 hours and a maximum of 72 hours of rest between sessions. The intervention will last for at least three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Measured using the Numeric Rating Scale (NRS), where the scale ranges from 0 to 10, with 0 representing 'no pain' and 10 representing 'worst possible pain'. Higher scores indicate a higher level of pain. | Day 1 |
| Knee Function (WOMAC) | Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which measures joint function, stiffness, and pain related explicitly to knee osteoarthritis. | Day 1 |
| Joint Mobility | Joint mobility will be assessed using a goniometer to measure any improvements or changes in the range of motion of the knee joint. | Day 1 |
| Physical Activity | Assessed using the International Physical Activity Questionnaire (IPAQ), gauges the level of physical activity and sedentary behaviour in daily life. Health-Related | Day 1 |
| Quality of Life ( SF-12) | Measured by the SF-12, a 12-item questionnaire that evaluates the patient's perceived quality of life, focusing on physical and mental health. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Measured using the Numeric Rating Scale (NRS) to assess changes in pain levels experienced by patients during rehabilitation and following the intervention. | up to 12 weeks |
| Knee Function (WOMAC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karmen Erjavec, prof. dr. | University of Novo Mesto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Novo mesto Faculty of Health Sciences | Novo Mesto | Slovenia |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
| Control group | Other | Patients in the control group will receive written instructions for a home exercise program. They will independently perform the rehabilitation program at home without remote supervision. The intervention includes targeted exercises for: Core muscle strength Strengthening of lower extremity muscles Mobility exercises for the hip, knee, and ankle joints Balance and stabilization exercises Each session lasts approximately 20-25 minutes, performed three times per week. Patients can choose the days for their sessions, with the requirement of a minimum of 24 hours and a maximum of 72 hours of rest between sessions. The intervention will last for at least three months. |
|
Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which measures joint function, stiffness, and pain related explicitly to knee osteoarthritis.
| up to 12 weeks |
| Physical Activity | Assessed using the International Physical Activity Questionnaire (IPAQ), gauges the level of physical activity and sedentary behaviour in daily life. | up to 12 weeks |
| Quality of Life ( SF-12) | Measured by the SF-12, a 12-item questionnaire that evaluates the patient's perceived quality of life, focusing on physical and mental health. | up to 12 weeks |
| Exercise Adherence and Frequency | Monitoring the regularity and consistency with which patients in both TG and CG complete the prescribed exercises, along with any challenges encountered that may influence adherence. | up to 12 weeks |
| Patient Satisfaction with telerehabilitation | Following the intervention, patients will provide feedback on their overall satisfaction with the telerehabilitation approach, including perceived benefits and limitations. | up to 12 weeks |
| Reasons for Reduced Exercise Engagement or Discontinuation | Patients will report any factors contributing to decreased exercise frequency or halting the rehabilitation program, particularly in the TG. | up to 12 weeks |
| Joint Mobility | Joint mobility will be reassessed using a goniometer to measure any improvements or changes in the range of motion of the knee joint. | up to 12 weeks |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001519 | Behavior |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |