Telerehabilitation for Knee Osteoarthritis: Study Protocol

NCT07137897 | Completed

• 1 other identifier: L7-50184
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Stiffness; Physical Function

Keywords

Telerehabilitation; knee; osteoarthritis; RCT; Physical Activity

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (8)

• Pain Intensity

  up to 12 weeks

• Knee Function (WOMAC)

  up to 12 weeks

• Physical Activity

  up to 12 weeks

• Quality of Life ( SF-12)

  up to 12 weeks

• Exercise Adherence and Frequency

  up to 12 weeks

Study Arms (2)

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.

Other: Control group

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.

Other: Telerehabilitation

Interventions

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.

Telerehabilitation Group

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.

Control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• University of Novo Mesto: lead

Study Sites (1)

University of Novo mesto Faculty of Health Sciences

Novo Mesto, Slovenia

Location

MeSH Terms

Conditions

Pain; Osteoarthritis; Motor Activity

Interventions

Telerehabilitation; Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Karmen Erjavec, prof. dr.

  University of Novo Mesto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: August 22, 2025
• Study Start: June 27, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 10, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-03

Locations

SL (1)