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PainNCT07137897

Telerehabilitation for Knee Osteoarthritis: Study Protocol

A study testing Telerehabilitation in people with Pain and Stiffness, run by University of Novo Mesto at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Pain, Stiffness, Physical Function
What is being tested?
Telerehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteSlovenia
Study dates
27 Jun 2024to 10 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site
  • University of Novo mesto Faculty of Health Sciences

    Novo Mesto

Other trials in Slovenia

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Telerehabilitation, Control group
Keywords
Telerehabilitation, knee, osteoarthritis, RCT, Physical Activity
Medical subject headings
Pain, Osteoarthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelerehabilitationOther

    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.

  • Control groupOther

    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.

Study groups in NCT07137897
Study groupRoleWhat they receive
Telerehabilitation GroupExperimentalPatients 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.
Receives: Other: Control group
Control groupActive comparatorPatients in the control group will receive only written exercise instructions and perform the rehabilitation program independently at home without additional remote supervision.
Receives: Other: Telerehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: Day 1

  4. Physical Activity

    Assessed using the International Physical Activity Questionnaire (IPAQ), gauges the level of physical activity and sedentary behaviour in daily life. Health-Related

    Measured: Day 1

  5. 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.

    Measured: Day 1

Secondary outcomes (8)
  1. Pain Intensity

    Measured using the Numeric Rating Scale (NRS) to assess changes in pain levels experienced by patients during rehabilitation and following the intervention.

    Measured: up to 12 weeks

  2. 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.

    Measured: up to 12 weeks

  3. Physical Activity

    Assessed using the International Physical Activity Questionnaire (IPAQ), gauges the level of physical activity and sedentary behaviour in daily life.

    Measured: up to 12 weeks

  4. 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.

    Measured: up to 12 weeks

  5. 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.

    Measured: up to 12 weeks

  6. Patient Satisfaction with telerehabilitation

    Following the intervention, patients will provide feedback on their overall satisfaction with the telerehabilitation approach, including perceived benefits and limitations.

    Measured: up to 12 weeks

  7. 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.

    Measured: up to 12 weeks

  8. 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.

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start27 Jun 2024
  3. Primary completion30 Oct 2025
  4. Study completion10 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07137897
Sponsor's protocol ID
L7-50184
Status last verified
Mar 2025
First submitted
24 Mar 2025
Last updated
2 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation in people with Pain and Stiffness, run by University of Novo Mesto at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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