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

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ClinicalTrials.gov Identifier: NCT04107350
Recruitment Status : Completed
First Posted : September 27, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Arthroplasty Complications Swelling; Leg Device: whole-body vibration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Single (Participant)
Masking Description: A single-blinded randomized control trial Intervention by the physical therapist Evaluation by the physician
Primary Purpose: Treatment
Official Title: The Whole Body Vibration Training for Total Knee arthroplasty-the Improvement of the Lower Limb
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: whole body vibration on
vibration machine on combined with conventional physical therapy
Device: whole-body vibration
10 minutes WBV exercise in standing position; amplitude 2mm,; frequency 4-10Hz; resting interval: 3 minutes rest.

Sham Comparator: whole body vibration off
vibration machine off combined with conventional physical therapy
Device: whole-body vibration
10 minutes WBV exercise in standing position; amplitude 2mm,; frequency 4-10Hz; resting interval: 3 minutes rest.




Primary Outcome Measures :
  1. pain scale (Numeric Rating Scale 0-10) [ Time Frame: 30 seconds ]
    pain with NRS before and after therapy

  2. lower leg circumference (cm) [ Time Frame: 1 minute ]
    Above knee 15cm and below knee 5cm circumference before and after therapy

  3. knee range of motion [ Time Frame: 30 seconds ]
    knee range of motion in degree with goniometer in supine position

  4. knee extensor muscle strength [ Time Frame: 1 minute ]
    knee extensor strength with dynamometer in knee flexion 45 degree, in kg in 3 times


Secondary Outcome Measures :
  1. Modified five times sit to stand test [ Time Frame: 5 minutes ]
    straight back chair with a solid seat 40 cm high. The investigator asked the participants to stand up and sit down as quickly as possible for 5 times, and the time spent were recorded.

  2. Modified timed up and go (TUG) test [ Time Frame: 5 minutes ]
    stand from seat height of 40 cm, walk a distance of 3 meters, turn around, walk back to the chair and sit down



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107350


Locations
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Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Study Chair: Chia-Hsin Chen, PhD Kaohsiung Medical University
  Study Documents (Full-Text)

Documents provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Publications:
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT04107350    
Other Study ID Numbers: KMUHIRB-F(II)-20170135
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases