Action Observation Therapy Via Telerehabilitation on Total Knee Arthroplasty Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery. The main questions it aims to answer are: [What is the effect of action observation therapy added to a telerehabilitation-based standard exercise program on patient-reported outcomes after total knee arthroplasty surgery?] [What is the effect of action observation therapy added to a telerehabilitation-based standardized exercise program on performance-based outcomes after total knee arthroplasty surgery?] Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group. Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing.

Detailed Description
-----------------
The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery. The secondary aim is to investigate the effect of a telerehabilitation-based standard exercise program added to the home program (information leaflet) on patient-reported and performance-based outcomes. The surgical operations of all patients participating in the study will be performed by the same surgical team and a standard physiotherapy program will be applied to all patients until discharge. Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group. Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing. Telerehabilitation sessions will include information about the process and exercise training. Action observation therapy will include showing videos of the exercises in the exercise program. All patients will be evaluated before surgery and at the third, sixth, and twelfth weeks after discharge. Evaluations Descriptive Data: Descriptive data of the patients will be recorded using an evaluation form. Patient Reported Assessments: Western Ontario McMaster University Osteoarthritis Index (WOMAC): This index questions clinically significant problems in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and knee. Pain intensity: Pain intensity will be assessed with the Visual Analog Scale (VAS). Knee range of motion: Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia) Quality of Life Assessment: Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Livings Scale (KOOS-ADLS) and EuroQol Group (EQ-5D) scales will be used for quality of life assessment.KOOS-ADLS is a scale used to detect symptoms and limitations in daily life tasks.The EQ-5D index scale consists of a questionnaire with five dimensions (movement, self-care, usual activities, pain/discomfort and anxiety/depression). Physical activity assessment: International Physical Activity Survey (IPAQ-Short Form) and smart phone pedometer application (Samsung Health®) will be used for physical activity assessment. The IPAQ-Short Form consists of 7 questions asking about various degrees of physical activity and sedentary behaviors in the past 1 week. Patient Satisfaction Assessments: Patient satisfaction with telerehabilitation sessions will be assessed. Technical quality (such as reliability of technology, quality of audio/video synchronization, quality of image, quality of sound), achievement of treatment goals of the session and overall satisfaction with the session will be questioned. Performance Based Assessments: The tests recommended by the research groups of 30 seconds of sit and stand, 40 meters fast walking and stair climbing will be used. Lower extremity muscle strength: Lower extremity muscle strength will be assessed by 30 seconds sit and stand test. Walking speed: In the 40-meter walk test, the patient is asked to walk a distance of 40 meters as fast as possible and the time in seconds is recorded. Locomotor performance: Locomotor performance will be assessed with the stair climbing test. The patient will be asked to ascend and descend 9 steps 16-20 centimeters long stairs as quickly but safely as possible.

Official Title
-----------------
Examining the Effect of Action Observation Therapy Added to the Telerehabilitation-Based Standard Exercise Program on Patient-Reported and Performance-Based Outcomes in Patients Undergoing Total Knee Arthroplasty Surgery

Conditions
-----------------
Knee Arthroplasty, Total, Telerehabilitation

Intervention / Treatment
-----------------
* Other: Standard exercise program based on telerehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteer 40 years and older Undergo primary unilateral total knee arthroplasty surgery after the diagnosis of osteoarthritis Can understand, speak and write Turkish Understand verbal and written information given Internet access Able to use video conferencing program Exclusion Criteria: Revision total knee arthroplasty surgery Previous major surgery on the extremity to be operated on Additional comorbid diseases such as rheumatoid arthritis, cancer Has any engine defect that may affect performance With a diagnosed psychiatric disorder People with alcohol or drug addiction Hearing or visual impairment that cannot be corrected with hearing aids or glasses Morbidly obese (BMI > 40 kg/m2) Who will not be able to participate in a six-week rehabilitation program Exclusion Criteria for Volunteers: Patients who did not come to follow-up after surgery for any reason, Patients who want to leave the study, Patients who are unable to continue the study due to an additional condition will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Home exercise group with information leaflet<br>These patients will be asked to do the exercises in the information leaflet themselves at home. | |
| Active Comparator: İnformation brochure+standard exercise program group based on telerehabilitation<br>Patients in this group will be followed up with telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 times a week for 6 weeks after discharge. | Other: Standard exercise program based on telerehabilitation<br>* Exercises included in a standard exercise program based on telerehabilitation; Week 0-3 Patellar mobilization Isometric quadriceps femoris exercise Terminal extension exercise Active assisted knee flexion Straight leg lift Active hip abduction Active assisted knee flexion in sitting SAFTE Cold pack application Week 3-6 Straight leg raises with weights Hip abduction in weighted side lying Knee flexion in the prone position Knee extension in weight-bearing sitting Sliding forward in the chair to increase the knee flexion angle Standing weighted hip abduction Standing knee flexion with weight Squat Walking Climbing stairs Action observation therapy will be practiced by watching videos of all exercises with a focus on close-up action.<br>* Other names: Action observation therapy added to a standard exercise program based on telerehabilitation;|
| Active Comparator: İnformation brochure+standard exercise program+action observation therapy group.<br>Patients in this group will be followed up with telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 times a week for 6 weeks after discharge. In addition, 15 minutes of movement observation therapy will be applied via video conferencing 3 days a week. | Other: Standard exercise program based on telerehabilitation<br>* Exercises included in a standard exercise program based on telerehabilitation; Week 0-3 Patellar mobilization Isometric quadriceps femoris exercise Terminal extension exercise Active assisted knee flexion Straight leg lift Active hip abduction Active assisted knee flexion in sitting SAFTE Cold pack application Week 3-6 Straight leg raises with weights Hip abduction in weighted side lying Knee flexion in the prone position Knee extension in weight-bearing sitting Sliding forward in the chair to increase the knee flexion angle Standing weighted hip abduction Standing knee flexion with weight Squat Walking Climbing stairs Action observation therapy will be practiced by watching videos of all exercises with a focus on close-up action.<br>* Other names: Action observation therapy added to a standard exercise program based on telerehabilitation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, stiffness and physical function (WOMAC) | • Western Ontario McMaster University Osteoarthritis Index (WOMAC): This index questions clinically significant problems in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and knee. | 5 minutes | 
| Pain intensity | Pain intensity will be assessed with the Visual Analog Scale (VAS). | 2 minutes | 
| Knee range of motion | Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia). | 5 minutes | 
| Physical activity assessment | IPAQ-Short Form and smartphone pedometer application (Samsung Health®) will be used for physical activity assessment. The IPAQ-Short Form consists of 7 questions asking about various degrees of physical activity and sedentary behaviors in the past 1 week. | 5 minutes | 
| Lower extremity muscle strength | Lower extremity muscle strength will be assessed by 30 seconds sit and stand test. | 30 seconds | 
| Walking speed | In the 40-meter walk test, the patient is asked to walk a distance of 40 meters as fast as possible and the time in seconds is recorded. | Average 5 minutes | 
| Locomotor performance | Locomotor performance will be assessed with the stair climbing test. The patient will be asked to ascend and descend 9 steps 16-20 centimeters long stairs as quickly but safely as possible. | Average 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessment | KOOS-ADLS and EQ-5D scales will be used for quality of life assessment.KOOS-ADLS is a scale used to detect symptoms and limitations in daily life tasks.The EQ-5D index scale consists of a questionnaire with five dimensions (movement, self-care, usual activities, pain/discomfort and anxiety/depression). | 10 minutes | 
| Patient satisfaction assessment | Patient satisfaction with telerehabilitation sessions will be assessed. Technical quality (such as reliability of technology, quality of audio/video synchronization, quality of image, quality of sound), achievement of treatment goals of the session and overall satisfaction with the session will be questioned. | 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telerehabilitation, Action Observation Therapy, Total Knee Arthroplasty, Patient-Reported Outcomes, Performance-Based Outcomes