The Purpose of this Clinical Trial Study is to Investigate the Immediate Effect of Whole Body Vibration on the Arthrogenic Inhibition of the Quadriceps Muscle in People with a CAR Level of less than 0.8 after Knee Surgeries. In this Study, 20 People Who Meet the Entry and Exit Criteria of the Study after 3 CAR Measurements through Electrical Stimulation will Enter the Intervention Stage. In this Stage, All the Participants will be Placed on the Vibration Plate with 110 Hz Specifications for 60 Seconds with their Knees Bent (30 degrees) and the Whole Body Vibration will be Applied to Them. . This Intervention is Repeated Three Times with an Interval of 2 Minutes. Immediately after the End of the Intervention, the Patient is Re-evaluated in the Above Mentioned way.
Design
Non-Randomized Clinical Trial
Settings and conduct
Faculty of Rehabilitation,Shahid Beheshti University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion Criteria: People Aged Between 20-50, Who have been at least 3 Months after Knee Joint Surgery, Who are Able to Stand and Walk without an Aid, Whose CAR Level is Less than 0.8, and their Pain Level is Less than 30 mm on the VAS Scale. Exclusion Criteria: Skeletal-Muscular or Neuro-Vascular Abnormality that Affects the Range of Motion of the Lower Limb Limit, Having a Balance Disorder, Having a History of Neurological Heart Disease, Taking any Special Medication during the Study will Cause People to be Excluded from the Study, An Increase in the Patient's Pain during the Intervention by 30 mm or more on the VAS Scale, if For any Reason, the Person does not want to Cooperate in the Study.
Intervention groups
Intervention Group: Applying Whole Body Vibration for 30 Seconds with a Specification of 110 Hz Three Times with an Interval of 2 Minutes
Main outcome variables
Central Activation Ratio؛Voluntary Maximum Torque of the Quadriceps Muscle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240413061477N1
Registration date:2024-06-22, 1403/04/02
Registration timing:registered_while_recruiting
Last update:2024-06-22, 1403/04/02
Update count:0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Hanie Yavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4408 5091
Email address
hanieyavari18991@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-31, 1403/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Whole Body Vibration on Arthrogenic Inhibition of Quadriceps Muscle after Knee Surgery
Public title
The Effect of Whole Body Vibration on Arthrogenic Inhibition of Quadriceps Muscle after Knee Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 4 Months have Passed since Knee Joint Surgery
The Age of People Should be Between 20-50
Having the Ability to Stand and Walk without an Aid
The Amount of CAR Should be Less than 0.8
Pain Less than 30 mm on the VAS Scale
Exclusion criteria:
Any Use of Special Drugs During the Study will Result in People be Excluded from the Study
If for any Reason the Person does not want to Cooperate in the study
An increase in the patient's pain during the Intervention by 30 mm or More on the VAS Scale
Having a History of Neurological Heart Disease
Having a balance disorder
Having Skeletal-Muscular or Neuro-Vascular Abnormality that Limits the Range of Motion of the Lower Limb
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Quantitative Measurement of Restraint by Digital Dynamometer
2
Description
Voluntary Maximum Torque of the Quadriceps Muscle
Timepoint
Before and After the Intervention
Method of measurement
Quantitative Measurement of Muscle Strength by Digital Dynamometer
Secondary outcomes
1
Description
Pain
Timepoint
Before and After the Intervention
Method of measurement
Using a Visual Pain Scale
Intervention groups
1
Description
Intervention Group: Whole Body Vibration Group / Vibration Frequency: 110Hz / Vibration Amplitude: 4mm (Peak to Peak) / Vibration Type: vertical vibration / exercise position: standing, with 30 degree knee Flexion, Without Socks and Shoes / Diversion Each Exercise: 60 Seconds / Rest Diversion between each Exercise: 120 Seconds / Number of Repetitions in each Set: 3 Times / Number of Sets: 1
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanie Yavari
Street address
Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Damavand Street
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
+98 21 7759 1807
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Siddiqa Sadat Naimi
Street address
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Damavand Street (New Tehran), Imam Hossein (AS) Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
+98 21 7759 1807
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khosro Khademi Kalantari
Position
full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
+98 21 7759 1807
Email
khosro_khademi@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khosro Khademi Kalantari
Position
full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
+98 21 7759 1807
Email
info@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Yavari
Position
Physiotherapy Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit 24, No 78, East Prophet Street, Abazar Blvd
City
Tehran
Province
Tehran
Postal code
1471717636
Phone
+98 21 4408 5091
Email
Hanieyavari1991@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available