The Whole Body Vibration Training for Total Knee arthroplasty-the Improvement of the Lower Limb
Phase: NA
Conditions: Knee Osteoarthritis, Arthroplasty Complications, Swelling; Leg
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

 
計 畫 書 英 文 摘 要
(Protocol Synopsis) 
文件編碼 
KMUH/IRB/AF/08F-10/000 
版次 
第10 版 
 
Version: 2  Date:1/14/2018 
1
計 畫 書 英 文 摘 要(Protocol Synopsis) 
 
Ⅰ.Protocol title: The whole body vibration training for total knee arthroplasty-the 
improvement of the lower limb 
Ⅱ.Objectives: Knee OA 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 ADL 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 ADL. 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. We 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. 
Ⅲ.Test drug 
1. Name: whole body vibration BW-750 
2. Dosage form: frequency 4-10 Hz, 10-15minutes with rest for 3-5 minutes * 2 
days in standing position 
3. 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 
4. Dosing schedule: whole body vibration 4-10 Hz for 10-15 minutes with rest 3-5 
minutes on post-op day 2 and day3 
5. Mechanism of action: passive muscle contraction, improve swelling, increase 
blood flow, and improve muscle strength 
6. Pharmacological category: N/A 
Ⅳ.Study design  
1. 
■ Control: ■ placebo 
□ active (please specify name and dosage) 
□ others             
□ Uncontrolled 
Protocol Synopsis
The 10th edition
Protocol Synopsis
文字
  Edition
 Number
14th January 2018

 
計 畫 書 英 文 摘 要
(Protocol Synopsis) 
文件編碼 
KMUH/IRB/AF/08F-10/000 
版次 
第10 版 
 
Version: 2  Date:1/14/2018 
2
2. Blinding: □ open-label    □ single blind    ■ double blind     □ others           
3. Randomized: ■ yes   □ no 
4. 
■ Parallel   □ cross-over   □ others          
5. Duration of study：from IRB approval ~to 31 , Dec. , 2019 ,total  24  months 
Duration of Enrollment : from IRB approval ~to   ,   ,   ,total       months 
Duration of treatment：from IRB approval ~to   ,   ,   ,total        months 
Duration of follow-up: from IRB approval ~to   ,   ,   ,total        months 
□ Multi-national   □multi-center(Taiwan)    ■ single center(Taiwan) 
6. Number of subjects:  80  persons       
7. Is there any of the followings included DSMB, Data Safety Monitoring Board:  
□ yes    ■no 
Ⅴ.Assessment criteria 
1. Efficacy: pain (VAS)，swelling circumference，knee range of motion，knee 
extensor muscle strength，time up and go，and ADL 
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 
1. Main inclusion criteria: knee osteoarthritis, post-operation of total knee 
arthroplasty, single leg 
2. 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)  
1. Written informed consent must be obtained before any study specific procedures are 
undertaken. 
2. The process of the experiment (brief describe) 
1. Randomized distribute participants into two groups, "whole body 
vibration(experimental group)+ traditional physical therapy" group and 
"placebo group with traditional physical therapy+ whole body vibration 
(placebo without turn-on vibration)".  
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文字
Protocol Syposis 
Edition
Number
The 10th edition 
14th January 2018

 
計 畫 書 英 文 摘 要
(Protocol Synopsis) 
文件編碼 
KMUH/IRB/AF/08F-10/000 
版次 
第10 版 
 
Version: 2  Date:1/14/2018 
3
2. Post-TKA day 1 (not op day) 
Pre-test (baselin data) include pain(VAS), leg circumference, knee ROM, knee 
extensor strength (JAMMAR), sit to stand average duration, 6 meters 
ambulatory test. 
Both groups receive traditional physical therapy and passive continuous 
passive motion (CPM). 
3. Post-TKA day 2  
Both groups keep trandition physical therapy and CPM. 
(1) The experimental group perform pre-test before the treatment. After the 
pre-test, participants receive 10-15 minutes WBV exercise in standing 
position, amplitudem2mm, frequency 4-10Hz, with rest about 3-5minutes. 
After the treatment, perform post-treatment test 1.    
(2) The control group standing on the WBV machine without turn-on for 
10-15 minutes and then post-treatment test 1.  
4. Post-TKA day 3 
(1) The experimental group participants receive 10-15 minutes WBV exercise 
in standing position, amplitude 2mm, frequency 4-10 Hz, with rest about 
3-5minutes. After the treatment, perform post-treatment test 2.    
(2) The control group standing on the WBV machine without turn-on for 
10-15 minutes and then post-treatment test 1. 
Ⅷ. Concomitant treatment: 
1. Permitted: pain-killer with acetaminophen, NSAIDs, and analgesic medication, 
traditional physical therapy and continuous passive motion of knee 
2. Prohibited: nil 
Ⅸ.Statistical analysis 
1. Statistical Method for Efficacy / Safety measurements: 
Demographic data were collected on age, pre-TKA OA X-ray Kellgren-Lawrence 
classification, sex, weight, height, side of involvement. We use t-test, or 
chi-square test to confirm homogeneity.  
On the other side, measurement the circulation of the affected limb above knee 
7cm, knee and below knee 7cm for swelling evaluation. Pain scale with 
Visual-Analogue scale; VAS) before intervention, post-test 1 and post-test 2. 
Muscle power of knee extensor by the duration with holding knee extension in 
14th January 2018
Protocol Syposis 
 Edition
 Number
The 10th edition 

 
計 畫 書 英 文 摘 要
(Protocol Synopsis) 
文件編碼 
KMUH/IRB/AF/08F-10/000 
版次 
第10 版 
 
Version: 2  Date:1/14/2018 
4
sitting position before intervention, post-test 1 and post-test 2  
Knee range of motion with goniometer in sitting (prone position)  
The duration of time up and go，6 meter ambulation test with walker usage.  
ADL evaluation with Barthel Index including transfer score, ambulation score, 
and up/down stairs score. Paired t-test is applied for statistical significance 
between these measurements. 
 
14th January 2018
The 10th edition 
 Edition
Number
Protocol synposis