Clinical trial NCT05514704: Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Knee Osteoarthritis.
Official title: Comparison of the Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is; To compare the effectiveness of asynchronous and synchronous telerehabilitation programs on pain, functional limitation, muscle strength, balance and quality of life parameters in patients with knee osteoarthritis.

60 patients with knee osteoarthritis who applied to Marmara University Faculty of Health Sciences Physiotherapy and Rehabilitation Department will be included in our study. The treatment and evaluations to be made will be explained and their consent will be obtained with their signatures. Patients will be randomly assigned to the asynchronous telerehabilitation group (n= 30 patients) and the synchronous telerehabilitation group (n= 30 patients). In the asynchronous telerehabilitation group, the rehabilitation program will be carried out via a mobile application (Diabetex). The coordinator will forward the exercise programs prepared specifically for the patients to the relevant participants through the application. On the other hand, telerehabilitation in the synchronous group will be carried out via video conference (Zoom). Patients will be taken to video conference calls and will perform their exercises simultaneously under the guidance of the researcher. An exercise program including lower extremity strengthening and stretching exercises will be applied to all patients. In both groups, the exercise program will be applied 3 days a week for 8 weeks, 1 session per day and 45 minutes per session. All outcome parameters will be evaluated by a blinded assessor who has not seen patients before. Patients starting the rehabilitation program will be evaluated at the beginning of the study, at weeks 4, 8, and 16.

The information of the patients participating in the study will be taken with the demographic data form. Pain in patients will be measured with the Visual Analog Scale, while the functionality of the patients will be evaluated with the WOMAC osteoarthritis index and the Lysholm Knee Scoring Scale. In addition, the affected quality of life of the patients will be evaluated with the Patient Generated Index and Short Form-12 scales. While the functional mobility of the patients was evaluated with the Timed Up and Go Test; functional capacities 2 Minute Walk Test, and lower extremity neuromuscular function levels 30 sec. It will be evaluated with Sit and Stand and 5 Sit and Stand performance tests. In addition, the Unilateral Posture Test, Limits of Stability Test, Sit and Stand Up Test will be performed using the NeuroCom Balance Master Posturography device for balance evaluation, and knee flexion and extension muscle strength and proprioception will be evaluated with the Isokinetic device.

Detailed description: Osteoarthritis is a degenerative joint disease that occurs progressively in load-bearing joints under the influence of various mechanical, chemical and physical factors. Knee osteoarthritis, which is one of the most common musculoskeletal disorders in the world, causes functional limitation by causing symptoms such as edema, joint stiffness, crepitation, joint instability and deformity, especially pain. Traditional physiotherapy and rehabilitation approaches such as pharmacological agents, patient education, exercise, electrotherapy agents, and mobilization techniques are used in the conservative treatment of knee osteoarthritis. With the developing technology, telerehabilitation applications appear as an alternative approach to traditional physiotherapy. Telerehabilitation applications offer a convenient treatment option that is easily accessible, cost-effective, encourages the patient to repeat multiple and regular repetitions, and provides self-control by getting instant feedback. Telerehabilitation applications are divided into two; synchronous telerehabilitation, which allows exercising simultaneously with patients via video conference, and asynchronous telerehabilitation, where data and images are recorded via various mobile applications, and the patient can access exercise therapy when desired.

Although there are a limited number of studies investigating the effectiveness of telerehabilitation in patients with knee osteoarthritis in the literature, there is no study comparing asynchronous and synchronous telerehabilitation. Based on all this information, the aim of our study is; To compare the effectiveness of asynchronous and synchronous telerehabilitation programs on pain, functional limitation, muscle strength, balance and quality of life parameters in patients with knee osteoarthritis.

60 patients with knee osteoarthritis who applied to Marmara University Faculty of Health Sciences Physiotherapy and Rehabilitation Department will be included in our study. The treatment and evaluations to be made will be explained and their consent will be obtained with their signatures. Patients will be randomly assigned to the asynchronous telerehabilitation group (n= 30 patients) and the synchronous telerehabilitation group (n= 30 patients). In the asynchronous telerehabilitation group, the rehabilitation program will be carried out via a mobile application (Diabetex). The coordinator will forward the exercise programs prepared specifically for the patients to the relevant participants through the application. On the other hand, telerehabilitation in the synchronous group will be carried out via video conference (Zoom). Patients will be taken to video conference calls and will perform their exercises simultaneously under the guidance of the researcher. An exercise program including lower extremity strengthening and stretching exercises will be applied to all patients. In both groups, the exercise program will be applied 3 days a week for 8 weeks, 1 session per day and 45 minutes per session. All outcome parameters will be evaluated by a blinded assessor who has not seen patients before. Patients starting the rehabilitation program will be evaluated at the beginning of the study, at weeks 4, 8, and 16.

The information of the patients participating in the study will be taken with the demographic data form. Pain in patients will be measured with the Visual Analog Scale, while the functionality of the patients will be evaluated with the WOMAC osteoarthritis index and the Lysholm Knee Scoring Scale. In addition, the affected quality of life of the patients will be evaluated with the Patient Generated Index and Short Form-12 scales. While the functional mobility of the patients was evaluated with the Timed Up and Go Test; functional capacities 2 Minute Walk Test, and lower extremity neuromuscular function levels 30 sec. It will be evaluated with Sit and Stand and 5 Sit and Stand performance tests. In addition, the Unilateral Posture Test, Limits of Stability Test, Sit and Stand Up Test will be performed using the NeuroCom Balance Master Posturography device for balance evaluation, and knee flexion and extension muscle strength and proprioception will be evaluated with the Isokinetic device.

We think that the comparison of asynchronous and synchronous telerehabilitation methods, which can be preferred in the rehabilitation of a health problem such as knee osteoarthritis, which significantly affects the quality of life of individuals, causing high cost expenditures and loss of workforce, will contribute to the literature.

Eligibility criteria: Inclusion Criteria:

* Pain less than or equal to 7 according to VAS
* Individuals aged 18-65
* Patients with independent mobility

Exclusion Criteria:

* Patients who have undergone surgery in the last 1 year
* Patients who have undergone total knee replacement or total hip replacement surgery
* Patients with acute trauma in the last 1 year
* Patients with uncontrolled chronic disease
* Patients who have received physical therapy in the last 6 months
* Patients who have received hyaluronic acid and corticosteroid injections in the last 6 months
* Patients with a respiratory condition that interferes with walking will not be included.

Primary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
timeFrame: The WOMAC will be measured at baseline 2 minutes after pain assessment.
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index
timeFrame: The WOMAC will be measured at the end of intervention (8. week) 2 minutes after pain assessment.
measure: Visual analogue scale (VAS)
timeFrame: The pain will be measured at study entry (baseline) after inclusion.
measure: Visual analogue scale (VAS)
timeFrame: The pain will be measured at the end of intervention (8. week).
Secondary outcomes:
measure: 12-Item Short Form Survey (SF-12)
timeFrame: The SF-12 will be measured at baseline 2 minutes after WOMAC assessment.
measure: 12-Item Short Form Survey (SF-12)
timeFrame: The SF-12 will be measured at the end of intervention (8. week) 2 minutes after WOMAC assessment.
measure: 30 Seconds Sit To Stand Test
timeFrame: The 30 Seconds Sit To Stand Test will be measured baseline 2 minutes after SF-12 assessment.
measure: 30 Seconds Sit To Stand Test
timeFrame: The 30 Seconds Sit To Stand Test will be measured at the end of intervention (8. week) 2 minutes after SF-12 assessment.
measure: 2 Minute Walk Test
timeFrame: The 2 Minute Walk Test will be measured at baseline 5 minutes after 30 Seconds Sit To Stand Test assessment.
measure: 2 Minute Walk Test
timeFrame: The 2 Minute Walk Test will be measured at the end of intervention (8. week) 5 minutes after 30 Seconds Sit To Stand Test assessment.
measure: Quadriceps and Hamstring Muscle Strength
timeFrame: The Quadriceps and Hamstring Muscle Strength will be measured at baseline 15 minutes after 2 Minute Walk Test assessment.
measure: Quadriceps and Hamstring Muscle Strength
timeFrame: The Quadriceps and Hamstring Muscle Strength will be measured at the end of intervention (8. week) 15 minutes after 2 Minute Walk Test assessment.
Other outcomes:
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