NCT04107350

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
Last Updated

September 30, 2019

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

September 16, 2019

Last Update Submit

September 26, 2019

Conditions

Knee OsteoarthritisArthroplasty ComplicationsSwelling; Leg

Outcome Measures

Primary Outcomes (4)

  • pain scale (Numeric Rating Scale 0-10)

    pain with NRS before and after therapy

    30 seconds

  • lower leg circumference (cm)

    Above knee 15cm and below knee 5cm circumference before and after therapy

    1 minute

  • knee range of motion

    knee range of motion in degree with goniometer in supine position

    30 seconds

  • knee extensor muscle strength

    knee extensor strength with dynamometer in knee flexion 45 degree, in kg in 3 times

    1 minute

Secondary Outcomes (2)

  • Modified five times sit to stand test

    5 minutes

  • Modified timed up and go (TUG) test

    5 minutes

Study Arms (2)

whole body vibration on

EXPERIMENTAL

vibration machine on combined with conventional physical therapy

Device: whole-body vibration

whole body vibration off

SHAM COMPARATOR

vibration machine off combined with conventional physical therapy

Device: whole-body vibration

Interventions

whole-body vibrationDEVICE

10 minutes WBV exercise in standing position; amplitude 2mm,; frequency 4-10Hz; resting interval: 3 minutes rest.

whole body vibration offwhole body vibration on

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee osteoarthritis
  • post-operation of total knee arthroplasty
  • single leg knee arthroplasty

You may not qualify if:

  • vital signs unstable
  • uncontrolled blood pressure
  • diabetes mellitus
  • neoplasm
  • neurological disorder
  • fibromyalgia
  • cardiac pacemaker
  • musculoskeletal involvement other than TKA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (1)

  • Park YG, Kwon BS, Park JW, Cha DY, Nam KY, Sim KB, Chang J, Lee HJ. Therapeutic effect of whole body vibration on chronic knee osteoarthritis. Ann Rehabil Med. 2013 Aug;37(4):505-15. doi: 10.5535/arm.2013.37.4.505. Epub 2013 Aug 26.

    PMID: 24020031BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Chia-Hsin Chen, PhD

    Kaohsiung Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A single-blinded randomized control trial Intervention by the physical therapist Evaluation by the physician
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: knee osteoarthritis status post total knee arthroplasty receive therapy on post-operation day 2 and post operation day 3 Study group: WBV+conventional physical therapy Control group: convention physical therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 27, 2019

Study Start

March 6, 2018

Primary Completion

November 16, 2018

Study Completion

January 10, 2019

Last Updated

September 30, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)