The Whole Body Vibration Training for Total Knee arthroplasty-the Improvement of the Lower Limb
The Whole Body Vibration Training for Total Knee arthroplasty-the Improvement of the Lower Limb
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.
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 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

 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)".

 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 traditional 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, amplitude 2mm,
 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.

 Statistical analysis 1. Statistical Method for Efficacy / Safety measurements:
 Demographic data were collected on age, pre-TKA Osteoarthritis X-ray
 Kellgren-Lawrence classification, sex, weight, height, side of involvement. The
 investigators use t-test, or chi-square test to confirm homogeneity.

 On the other side, measurement the circulation of the affected limb above knee 15
 cm, knee and below knee 5cm for swelling evaluation. Pain scale with Numeric Rating
 Scale; NRS) before intervention, post-test 1 and post-test 2. Muscle power of knee
 extensor by the duration with holding knee extension in 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.

 Discussion The investigator expected that post treatment, the patients in the
 vibration group got increases in knee extensor strength, improvement in calf
 swelling and functional performance when compared to the control group.
Inclusion Criteria:

 -  knee osteoarthritis

 -  post-operation of total knee arthroplasty

 -  single leg knee arthroplasty

 Exclusion Criteria:

 -  vital signs unstable

 -  uncontrolled blood pressure

 -  diabetes mellitus

 -  neoplasm

 -  neurological disorder

 -  fibromyalgia

 -  cardiac pacemaker

 -  musculoskeletal involvement other than TKA