The Whole Body Vibration Training for Total Knee arthroplasty-the Improvement of the Lower Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- pain scale (Numeric Rating Scale 0-10)
研究概览
简要总结
Knee Osteoarthritis in elder cause pain and decrease their functional activity. After conservative rehabilitation failure, they might receive total knee arthroplasty. The post-operation rehabilitation could improve range of motion and might help them to back activities of daily Living earlier. However, the pain and swelling after the operation of total knee arthroplasty cause the limitation of early mobilization, cause ROM limitation, muscle strength decrease, functional activity decrease, and impaired activity of daily life. In recent studies, the effect of whole body vibration included improving pain, swelling, muscle strength, balance, and functional activity, increasing metabolic rate and decreasing lactate accumulation. the investigators expect the early intervention of whole body vibration and traditional physical therapy on the post-TKA patient could improve ROM, decrease swelling, increased muscle strength, functional activity, and balance as compared with traditional physical therapy.
详细描述
- Name: whole body vibration BW-750
- Dosage form: frequency 4-10 Hz, 10-15minutes with rest for 3-5 minutes * 2 days in standing position
- Dose(s): post-op day2, WBV 4-10 Hz, 10-15minutes with rest for 3-5 minutes, post-op day3 WBV 4-10 Hz, 10-15 minutes with 3-5 minutes in standing position
- Dosing schedule: whole body vibration 4-10 Hz for 10-15 minutes with rest 3-5 minutes on post-op day 2 and day3
- Mechanism of action: passive muscle contraction, improve swelling, increase blood flow, and improve muscle strength
- Pharmacological category: N/A
IV.Study design 1. ■ Control: ■ placebo 2. Blinding: ■ double blind 3. Randomized: ■ yes □ no 4. ■ Parallel 5. Duration of study:from IRB approval ~to 31 , Dec. , 2019 6. Number of subjects: 52 persons 7. Is there any of the followings included DSMB, Data Safety Monitoring Board:
- no V.Assessment criteria 1. Efficacy: pain (VAS)，swelling circumference，knee range of motion，knee extensor muscle strength，time up and go，and Activities of Daily Living 2. Safety: The duration and frequency of whole body vibration is relative low. The risk of damage is very low 3. Pharmacokinetics: Not apply 4. Quality of life: Through facilitate muscle contraction, improve blood flow, and decrease pain could improve muscle power, increase range of motion and ADL VI. Selection criteria
- Main inclusion criteria: knee osteoarthritis, post-operation of total knee arthroplasty, single leg
- Main exclusion criteria: vital signs unstable, uncontrolled blood pressure, diabetes mellitus, neoplasm, neurological disorder, fibromyalgia, cardiac pacemaker, bilateral TKA, musculoskeletal involvement other than TKA VII.Study procedures(summary)
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
- Single (Participant)
盲法说明
A single-blinded randomized control trial Intervention by the physical therapist Evaluation by the physician
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •knee osteoarthritis
- •post-operation of total knee arthroplasty
- •single leg knee arthroplasty
排除标准
- •vital signs unstable
- •uncontrolled blood pressure
- •diabetes mellitus
- •neurological disorder
- •fibromyalgia
- •cardiac pacemaker
- •musculoskeletal involvement other than TKA
研究组 & 干预措施
whole body vibration on
vibration machine on combined with conventional physical therapy
干预措施: whole-body vibration (Device)
whole body vibration off
vibration machine off combined with conventional physical therapy
干预措施: whole-body vibration (Device)
结局指标
主要结局
pain scale (Numeric Rating Scale 0-10)
时间窗: 30 seconds
pain with NRS before and after therapy
lower leg circumference (cm)
时间窗: 1 minute
Above knee 15cm and below knee 5cm circumference before and after therapy
knee range of motion
时间窗: 30 seconds
knee range of motion in degree with goniometer in supine position
knee extensor muscle strength
时间窗: 1 minute
knee extensor strength with dynamometer in knee flexion 45 degree, in kg in 3 times
次要结局
- Modified five times sit to stand test(5 minutes)
- Modified timed up and go (TUG) test(5 minutes)