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Telerehabilitation for Knee Osteoarthritis: Study Protocol

Telerehabilitation of Patients With Osteoarthritis of the Knee Joint: Study Protocol for a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07137897
Enrollment
118
Registered
2025-08-22
Start date
2024-06-27
Completion date
2025-11-10
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Physical Function, Stiffness

Keywords

Telerehabilitation, knee, osteoarthritis, RCT, Physical Activity

Brief summary

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.

Detailed description

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: * Sociodemographic characteristics: age, gender, education, employment status. * Anthropometric measurements: height (cm), weight (kg), body mass index (BMI) (kg/m²). * Assessment of knee joint mobility: measurement of range of movement with a goniometer. * Pain intensity: Use the Numerical Rating Scale (NRS) to measure subjective pain. Assessment of physical function, stiffness, and pain: The validated Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire is used. * Physical activity assessment: performed using the International Physical Activity Questionnaire (IPAQ). * Assessment of health-related quality of life: administered by the 12-item Short Form Health Survey (SF-12). * Osteoarthritis severity classification: based on knee radiographs (≤ 4 months old) and will be performed according to the Kellgren-Lawrence classification system. Patients will be randomly assigned to one of two groups: * telerehabilitation group (TR): They will be enrolled in a tailored physiotherapy programme, including individually tailored exercises to strengthen, stretch, and improve the functionality of the knee joint. * control group (CG): patients will continue with standard care without additional therapeutic interventions. 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.

Interventions

OTHERTelerehabilitation

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.

OTHERControl group

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.

Sponsors

University of Novo Mesto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with symptomatic OA of the knee joint, graded 1-3 on the Kellgren-Lawrence scale 2. Patients older than 50 years 3. Patients with access to and proficiency in using a computer, 4. Patients with the capability to follow the exercises outlined.

Exclusion criteria

1. Grade 4 cartilage defect (cartilage defect up to the subchondral bone), for which surgical treatment is professionally indicated, 2. Planned arthroplasty of the knee joint within the next 6 months, 3. Patients who have had a previous TEP arthroplasty or partial knee arthroplasty (hereafter PEP), 4. Patients with a history of trauma or surgical treatment of the knee joint (osteotomy or treatment of cartilage lesions) in the last 6 months, 5. Patients who have received an intra-articular injection in the knee joint in the last 3 months, 6. Patients who have systemic inflammatory arthritis (e.g. rheumatoid arthritis or gout) or those who have concomitant medical conditions that prevent participation in exercise, 7. Patients who have cognitive impairments or are wheelchair users, 8. Who has co-morbidities, 9. Those who do not have access to a computer have limited language skills that prevent the correct use of tele-rehabilitation or 10. Those who are involved in similar study.

Design outcomes

Primary

MeasureTime frameDescription
Pain IntensityDay 1Measured 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.
Knee Function (WOMAC)Day 1Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which measures joint function, stiffness, and pain related explicitly to knee osteoarthritis.
Joint MobilityDay 1Joint mobility will be assessed using a goniometer to measure any improvements or changes in the range of motion of the knee joint.
Physical ActivityDay 1Assessed using the International Physical Activity Questionnaire (IPAQ), gauges the level of physical activity and sedentary behaviour in daily life. Health-Related
Quality of Life ( SF-12)Day 1Measured by the SF-12, a 12-item questionnaire that evaluates the patient's perceived quality of life, focusing on physical and mental health.

Secondary

MeasureTime frameDescription
Patient Satisfaction with telerehabilitationup to 12 weeksFollowing the intervention, patients will provide feedback on their overall satisfaction with the telerehabilitation approach, including perceived benefits and limitations.
Pain Intensityup to 12 weeksMeasured using the Numeric Rating Scale (NRS) to assess changes in pain levels experienced by patients during rehabilitation and following the intervention.
Joint Mobilityup to 12 weeksJoint mobility will be reassessed using a goniometer to measure any improvements or changes in the range of motion of the knee joint.
Reasons for Reduced Exercise Engagement or Discontinuationup to 12 weeksPatients will report any factors contributing to decreased exercise frequency or halting the rehabilitation program, particularly in the TG.
Knee Function (WOMAC)up to 12 weeksEvaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which measures joint function, stiffness, and pain related explicitly to knee osteoarthritis.
Physical Activityup to 12 weeksAssessed using the International Physical Activity Questionnaire (IPAQ), gauges the level of physical activity and sedentary behaviour in daily life.
Quality of Life ( SF-12)up to 12 weeksMeasured by the SF-12, a 12-item questionnaire that evaluates the patient's perceived quality of life, focusing on physical and mental health.
Exercise Adherence and Frequencyup to 12 weeksMonitoring 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.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026