Telerehabilitation of Patients With Osteoarthritis of the Knee Joint: Study Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Telerehabilitation Group
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.
干预措施: Control group (Other)
Control group
Patients in the control group will receive only written exercise instructions and perform the rehabilitation program independently at home without additional remote supervision.
干预措施: Telerehabilitation (Other)
结局指标
主要结局
Pain Intensity
时间窗: 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.
Knee Function (WOMAC)
时间窗: 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.
Joint Mobility
时间窗: 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.
Physical Activity
时间窗: Day 1
Assessed 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)
时间窗: 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.
次要结局
- 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)
- Patient Satisfaction with telerehabilitation(up to 12 weeks)
- Reasons for Reduced Exercise Engagement or Discontinuation(up to 12 weeks)
- Joint Mobility(up to 12 weeks)
研究者
Karmen Erjavec
Principal Investigator
University of Novo Mesto