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The Effect of Whole Body Vibration (WBV) on Dynamic Postural Stability during Jump Landing in Athletes Following Anterior Cruciate Ligament Reconstruction

Protocol summary

Study aim
The Effect of Whole Body Vibration (WBV) on Dynamic Postural Stability during Jump Landing in Athletes after Anterior Cruciate Ligament Reconstruction
Design
Parallel, double blinded, randomised clinical trial with control group; Balanced Block Randomization by Randomization.com
Settings and conduct
Selected Participants will be given Explanations on how to conduct the R esearch and, if desired, the person will give his / her informed consent by signing a written consent. First, the evaluations are performed and the treatments are performed in the control group (exercise therapy) and in the intervention group (WBV + exercise therapy) for 4 weeks, and 48 hours after the last treatment session, the evaluation is performed again.
Participants/Inclusion and exclusion criteria
History of Anterior Cruciate Ligament Surgery (Hamstrings) without Surgery for Other Ligament and Meniscus Injuries More than 6 Months have passed since the Surgery; The operated Leg should be One-Sided; Having Mild to Moderate Physical Activity (at least 3 Times a Week and more than 30 Minutes each Time) in Jumping Sports; No Pain, Inflammation and Limited Range of Motion in the Knee Joint; The Person has returned to Exercise with the Advice of a Doctor and has received some Rehabilitation Programs after Surgery and before entering the Study; Not having Items that prohibit Whole Body Vibration.
Intervention groups
Participants in the Control Group receive only Exercise Therapy; In addition to Exercise Therapy, the Treatment Group also receives Whole Body Vibration.
Main outcome variables
AnteroPosterior (AP); Mediolateral(ML); vertical&resultant stability index(SI) during forward jump landing(FJL)& diagonal Jump Landing(DJL); AP/ML/ vertical and resultant time to stabilization(TTS) during FJL & DJL; Distance traveled in the Y balance test in the anterior, posteromedial and posterolateral directions

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220226054122N1
Registration date: 2022-03-01, 1400/12/10
Registration timing: prospective

Last update: 2022-03-01, 1400/12/10
Update count: 0
Registration date
2022-03-01, 1400/12/10
Registrant information
Name
Zahra Rostampour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5514 2480
Email address
z.rostampur@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Whole Body Vibration (WBV) on Dynamic Postural Stability during Jump Landing in Athletes Following Anterior Cruciate Ligament Reconstruction
Public title
Investigation of Whole Body Vibration Effect on Stability during Jump Landing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of Anterior Cruciate Ligament Surgery (Hamstrings) without Surgery for Other Ligament and Meniscus Injuries More than 6 Months have passed since the Surgery The operated Leg should be One-Sided Having Mild to Moderate Physical Activity (at least 3 Times a Week and more than 30 Minutes each Time) in Jumping Sports such as Volleyball, Basketball, Football, Handball, etc. No Pain, Inflammation and Limited Range of Motion in the Knee Joint The Person has returned to Exercise with the Advice of a Doctor and has received some Rehabilitation Programs after Surgery and before entering the Study
Exclusion criteria:
Not having Items that prohibit Whole Body Vibration (Pregnancy, Acute Thrombosis, Severe Cardiovascular Problems, Pacemaker, Discopathy, Spondylosis, Severe Diabetes, Epilepsy, Acute Infection, Severe Migraine, Tumor, Kidney Stones)
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Random َAllocation will be done through Randomization.com and Balanced Block Randomization Method. The Size of the Blocks is 4. Also, for Allocation Concealment, sealed and numbered Envelopes are used, which are provided to the Participants by the Secretary.
Blinding (investigator's opinion)
Double blinded
Blinding description
Assessor and Analyser
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical sciences
Street address
13th Floor, A block, Headquarters of the Ministry of Health, Simaye Iran Ave, between Zarafshan and South Falamak, Qods town
City
Tehran
Province
Tehran
Postal code
1363945641
Approval date
2022-02-23, 1400/12/04
Ethics committee reference number
IR.TUMS.FNM.REC.1400.211

Health conditions studied

1

Description of health condition studied
Poor Dynamic Postural Stability
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Anterior Cruciate Ligament Reconstruction Surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
AnteroPosterior/MedioLateral/ vertical and resultant time to stabilization during forward and diagonal jump landing
Timepoint
Before intervention and 48 hours after last treatment session
Method of measurement
Force plate

2

Description
AnteroPosterior/Mediolateral/ vertical and resultant stability index during forward and diagonal jump landing
Timepoint
Before intervention and 48 hours after last treatment session
Method of measurement
Force plate

Secondary outcomes

1

Description
Distance traveled in Y balance test in anterior/posteromedial and posterolateral
Timepoint
Before intervention and 48 hours after last treatment session
Method of measurement
Y balance test

Intervention groups

1

Description
Intervention group: Whole Body Vibration and exercise training 3 sessions a week and for 4 week. 9 positions are defined for the person, each of which from sessions 1 to 12 with different repetitions on the Whole Body Vibration device with a frequency between 30 to 50 Hz, amplitude 2.5 to 5 mm, number of sets between 8 to 16, rest Between sets of 60 seconds and duration of vibration 4 to 16 minutes, are performed from the first session to 12th session. Position 1: legs in the middle of the plate and slightly apart, knees slightly bent and back straight , Position 2: Standing on one leg, middle leg Plate, knees also slightly bent and waist straight, Position 3: Mini-squat / Position 4: Mini-squat on one leg / Position 5: Squat / Position 6: Squat on one leg / Position 7: Squat with the legs apart ./ Position 8: One foot in the middle of the plate and the other foot outside the plate, knees at 90 degrees flexion and back straight / Position 9: Standing on toes
Category
Rehabilitation

2

Description
Control group: exercise training. 10 RM. exercise training include strength training and perturbation training. 12 sessions: 3 sessions per week for 4 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Medicine Federation of Iran
Full name of responsible person
Zahra Rostampour
Street address
No.17, Varzandeh Ave., South Moffateh Ave
City
Tehran
Province
Tehran
Postal code
1571745613
Phone
+98 21 83826
Fax
Email
info@ifsm.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr.fotouhi
Street address
Sixth floor,Central Organization of the University,Qods Ave,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Rostampour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Farahani Alley, Kamali Ave, Abouzar Blvd
City
Tehran
Province
Tehran
Postal code
1363945641
Phone
+98 21 5514 2480
Fax
Email
z.rostampur@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Khanmohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Piche Shemiran Ave, Rehabilitation Faculty
City
Tehran
Province
Tehran
Postal code
1363945641
Phone
+98 21 7753 3939
Fax
Email
rkhanmohammadi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Rostampour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Farahani Alley, Kamali Ave, Abouzar Blvd
City
Tehran
Province
Tehran
Postal code
1363945641
Phone
+98 21 5514 2480
Fax
Email
z.rostampur@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
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