Investigation the Effectiveness of Exercise Device in the Rehabilitation of Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change range of motion
研究概览
简要总结
Total knee arthroplasty is performed in patients with advanced stages of osteoarthritis who can not respond to conservative treatment, in order to reduce pain, increase range of motion, and improve function and quality of life. Continuous passive motion device continues to be used in many clinics, although it has been shown that there is no effect in total knee arthroplasty rehabilitation. The aim of the study was to assess the clinical effects of the knee exercise device on pain, ROM and function and quality of life in total knee arthroplasty rehabilitation.
详细描述
Volunteers with total knee arthroplasty according to the criteria of inclusion, who will be operated in Istanbul University Istanbul Medical Faculty Orthopedics and Traumatology Department will be included this study. Participants will be randomly allocated 2 groups: easy-flex group and traditional exercise group. Exercise group will be treated with the traditional exercise program and the Easy-Flex group will be treated with the Easy-Flex device in addition to the traditional exercise program.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with TKA surgery due to the diagnosis of knee OA Between the ages of 45-80 years Patients with no difference over 5 cm in the extremity before and after surgery
排除标准
- •Revision TKA, Previous unicompartmental arthroplasty or tibial osteotomy, Hemophilia, Uncontrolled hypertension Rheumatic diseases, Lower extremity fractures and tumors, Neurological diseases leading to muscle weakness in the lower limbs, Patients with emotional and cognitive problems
结局指标
主要结局
Change range of motion
时间窗: Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.
Range of motion of knee flexion and extension
次要结局
- WOMAC(Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.)
- Short Form 12 (SF-12)(Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.)
- 10 meter walking test(Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.)
- NPRS (Numerical Pain Rating Scale)(Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.)
- Satisfaction levels of the patients(At sixth week)
- 5 sit to stand(Assessment is performed at pre-op and post-op second and sixth weeks rehabilitation program.)
研究者
Zeynal YASACI
Research Assistant; Principal Investigator
Istanbul University