Clinical trial NCT05501197: Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Meniscus Degeneration
Official title: Comparison of the Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Meniscus Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniscus; Degeneration
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-08-15
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: Our study will include 60 patients diagnosed with meniscus degeneration in the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Marmara University. Volunteers will be informed about the purpose of the study and the evaluations and treatments to be carried out, and their consent will be obtained by reading the 'Informed Volunteer Consent Form' and obtaining their signatures. The sample group and distribution will be determined as 30 asynchronous telerehabilitation groups and 30 synchronous telerehabilitation groups. Our study is a randomized controlled trial. Groups will be formed in a randomized manner and blinded study design will be used to evaluate outcome parameters. Patients beginning the rehabilitation program will be evaluated at the start of the study, at week 4, week 8, and week 16. Demographic information of the patients participating in the study will be obtained using the demographic data form. Visual Analogue Scale (VAS) for pain, WOMET index for functionality and quality of life, functionality with Lysholm Knee Scoring Scale and quality of life with Patient Generated Index (PGI) and Short Form-12 (SF-12) scales; Functional mobility Timed Up and Go Test (TUG), functional capacity 2 Minutes Walk Test (2 MWT), balance Balance Master, proprioception and muscle strength Isokinetic assessment device, lower extremity neuromuscular function level 30 sec Sit Up and 5 Sit \& Go performance tests will be evaluated with Our study will investigate the comparison of the effects of asynchronous and synchronous telerehabilitation programs on pain, functional limitation, muscle strength and quality of life in patients with meniscal degeneration.

Detailed description: Meniscus degeneration is a common problem in the society and is a health problem that can be seen at any age and affects a large part of the population. The functions of the menisci are load bearing, load transfer, shock absorption and lubrication. Meniscus degeneration occurs as a part of the degenerative process of the knee joint and shows symptoms such as pain and instability in people, and these symptoms are associated with functional limitation. Treatment of meniscus degeneration can be classified as pharmacological, non-pharmacological and surgical treatment. Nonpharmacological treatment uses traditional physiotherapy and rehabilitation approaches such as patient education, exercise therapy, and various physiotherapy applications. Exercises used in the treatment of meniscus degeneration aim to reduce pain, provide joint range of motion, increase knee joint functions, protect muscle strength and joint proprioception. Thus, it is predicted that the participation of patients in social life will increase.

With the developing technology, telerehabilitation applications appear as an alternative approach to traditional physiotherapy approaches. Telerehabilitation provides access to patients by using information and communication technologies and provides rehabilitation services in this way. There are two types of telerehabilitation, synchronous and asynchronous rehabilitation. Applications that allow instant interaction via a webcam for synchronous rehabilitation, telephone or video conferencing connection. Asynchronous rehabilitation, on the other hand, can be defined as applications that transmit recorded video and audio recording data for later interpretation by a specialist. Studies on telerehabilitation are limited in the literature. There are no studies measuring the effectiveness of asynchronous and synchronous telerehabilitation in patients with meniscal degeneration. Especially under the conditions of the COVID-19 pandemic, patients cannot get an appointment for the physiotherapy service, the waiting time for treatment is prolonged, physiotherapy and rehabilitation services are costly, the patients have difficulty in reaching the physiotherapy service due to their geographical location, especially the patients who complain of lower extremity problems travel long distances and reach the rehabilitation unit in long hours. For this reason, the inability to get efficiency from physical therapy enabled us to conduct research on telerehabilitation.

Our study will include 60 patients diagnosed with meniscus degeneration in the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Marmara University. Volunteers will be informed about the purpose of the study and the evaluations and treatments to be carried out, and their consent will be obtained by reading the 'Informed Volunteer Consent Form' and obtaining their signatures. The sample group and distribution will be determined as 30 asynchronous telerehabilitation groups and 30 synchronous telerehabilitation groups. Our study is a randomized controlled trial. Groups will be formed in a randomized manner and blinded study design will be used to evaluate outcome parameters. Patients beginning the rehabilitation program will be evaluated at the start of the study, at week 4, week 8, and week 16. Demographic information of the patients participating in the study will be obtained using the demographic data form. Visual Analogue Scale (VAS) for pain, WOMET index for functionality and quality of life, functionality with Lysholm Knee Scoring Scale and quality of life with Patient Generated Index (PGI) and Short Form-12 (SF-12) scales; Functional mobility Timed Up and Go Test (TUG), functional capacity 2 Minutes Walk Test (2 MWT), balance Balance Master, proprioception and muscle strength Isokinetic assessment device, lower extremity neuromuscular function level 30 sec Sit Up and 5 Sit \& Go performance tests will be evaluated with Our study will investigate the comparison of the effects of asynchronous and synchronous telerehabilitation programs on pain, functional limitation, muscle strength and quality of life in patients with meniscal degeneration.

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: The Lysholm score
timeFrame: The The Lysholm score will be measured at baseline 2 minutes after pain assessment.
measure: The Lysholm score
timeFrame: The The Lysholm score 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 baseline
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 The Lysholm score 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 The Lysholm score assessment.
measure: 30 Seconds Sit To Stand Test
timeFrame: The 30 Seconds Sit To Stand Test will be measured at 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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