The purpose of this study,is determining the acute effect of whole body vibration on strength and balance in copers versus noncopers of anterior cruciate ligament injury. In this clinical trial study; 23 male athletic subjects with ACL rupture (12 coper, 12 noncoper) and 10 male healthy athletic are completely matched with the patients, will selected. All 3 group of subjects will complete interventions of WBV and sham WBV. The WBV treatment consists of 5 sets of 1min of vibration (30 Hz, 3 mm) while standing in a squat position (30˚ knee flex). The sham WBV treatment iwill be standing in a squat position (30˚ knee flex) on WBN system platform with no any vibration. Postural control will measure through the Biodex Stability System in two levels (4 & 8). The strength will evaluate by Isokinetic dynamometer and parameters will set at angular velocity of 60°/s and concentric form. The results will analyses with multiple ANOVA at significance level p<0.05 and power< 80% .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405281637N4
Registration date:2016-02-07, 1394/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Sedighe Kahrizi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4511
Email address
kahrizis@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The acute effect of whole body vibration on muscle strength and postural stability in anterior cruciate ligament injury:copers versus noncopers
Public title
Effect of whole body vibration on muscle strength and Postural Stability
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: athletic subjects with age between 20 and 30 years; unilateral ACL rupture on dominant leg confirmed with magnetic resonance imaging (MRI): clinical evaluation within 2-6 months of injury and having regular activities of Level I or II( as IKDC scale );full passive ROM; no swelling; able to walk without a limp; full active knee extension and the ability to hop on one leg without pain.
Exclusion criteria: to have history of any neurological disease or vestibule dysfunction; uncorrected vision problems; previous anterior cruciate ligament injury; concomitant ligamentous injury; bilateral involvement, symptomatic menisci or cartilage injury presence of hip or ankle pathology; fracture; leg or back pain and diabetes
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Postal code
1913634951
Approval date
2013-07-13, 1392/04/22
Ethics committee reference number
52/2015
Health conditions studied
1
Description of health condition studied
ACL injury
ICD-10 code
S83.5
ICD-10 code description
Anterior cruciate ligament
Primary outcomes
1
Description
Knee Muscles Strength
Timepoint
before and after intervention
Method of measurement
Isokinetic
Secondary outcomes
1
Description
Postural Stability
Timepoint
before and after intervention
Method of measurement
Biodex Balance System
Intervention groups
1
Description
Squat Position(knee in 30 flexion)
Category
Placebo
2
Description
whole body vibration
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Sedighe Kahrizi
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Yaghoub Fathollahi
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shahram Hosseinpour Shoja Abad
Position
MSc
Other areas of specialty/work
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Postal code
1913634951
Phone
+98 21 8288 4511
Fax
Email
hosseinpour.shahram@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedighe Kahrizi
Position
PhD
Other areas of specialty/work
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Postal code
1913634951
Phone
+98 21 8288 4511
Fax
Email
kahrizis@modares.ac.ir
Web page address
www.modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Kahrizi
Position
PhD
Other areas of specialty/work
Street address
Tarbiat Modares University, Jalal Ale Ahmad Highway, P.O.Box: 14115-111, Tehran, Iran
City
Tehran
Postal code
1913634951
Phone
+98 21 8288 4511
Fax
+98 21 8288 4511
Email
kahrizis@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)