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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
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.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Pain intensity
时间窗: 2 minutes
Pain intensity will be assessed with the Visual Analog Scale (VAS).
Pain, stiffness and physical function (WOMAC)
时间窗: 5 minutes
• 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.
Knee range of motion
时间窗: 5 minutes
Active and passive knee range of motion will be measured in the sitting position with a digital goniometer (HALO Medical Devices, Australia).
Walking speed
时间窗: Average 5 minutes
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.
Lower extremity muscle strength
时间窗: 30 seconds
Lower extremity muscle strength will be assessed by 30 seconds sit and stand test.
Locomotor performance
时间窗: Average 5 minutes
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.
Physical activity assessment
时间窗: 5 minutes
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.
次要结局
- Quality of Life Assessment(10 minutes)
- Patient satisfaction assessment(2 minutes)
研究者
Nihal BÜKER
Proffesor
Pamukkale University