University of Novo mesto Faculty of Health Sciences
Novo Mesto, Slovenia
NCT Number: NCT07137897
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.
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Notify Me50 year–80 year
All sexes
Interventional
Not applicable
Novo Mesto, Slovenia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Day 1
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.
Time frame: Day 1
Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which measures joint function, stiffness, and pain related explicitly to knee osteoarthritis.
Time frame: Day 1
Joint mobility will be assessed using a goniometer to measure any improvements or changes in the range of motion of the knee joint.
Time frame: Day 1
Assessed using the International Physical Activity Questionnaire (IPAQ), gauges the level of physical activity and sedentary behaviour in daily life. Health-Related
Time frame: Day 1
Measured by the SF-12, a 12-item questionnaire that evaluates the patient's perceived quality of life, focusing on physical and mental health.
Time frame: up to 12 weeks
Measured using the Numeric Rating Scale (NRS) to assess changes in pain levels experienced by patients during rehabilitation and following the intervention.
Time frame: up to 12 weeks
Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which measures joint function, stiffness, and pain related explicitly to knee osteoarthritis.
Time frame: up to 12 weeks
Assessed using the International Physical Activity Questionnaire (IPAQ), gauges the level of physical activity and sedentary behaviour in daily life.
Time frame: up to 12 weeks
Measured by the SF-12, a 12-item questionnaire that evaluates the patient's perceived quality of life, focusing on physical and mental health.
Time frame: up to 12 weeks
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.
Time frame: up to 12 weeks
Following the intervention, patients will provide feedback on their overall satisfaction with the telerehabilitation approach, including perceived benefits and limitations.
Time frame: up to 12 weeks
Patients will report any factors contributing to decreased exercise frequency or halting the rehabilitation program, particularly in the TG.
Time frame: up to 12 weeks
Joint mobility will be reassessed using a goniometer to measure any improvements or changes in the range of motion of the knee joint.
University of Novo Mesto
Other
Telerehabilitation of Patients With Osteoarthritis of the Knee Joint: Study Protocol for a Randomised Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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