Protocol summary

Study aim
1. comparison of changes of head horizontal alignment before and after WBV between two groups. 2. comparison of changes of distance between Acromion and 7th cervical vertebra before and after WBV between two groups. 3. comparison of changes of Acromion horizontal alignment before and after WBV between two groups. 4. comparison of changes of thoracic kyphosis before and after WBV between two groups. 5. comparison of changes of pectoralis minor lenght before and after WBV between two groups. 6. comparison of changes of total distance of scapula before and after WBV between two groups.
Design
The subjects with rounded shoulder according to the inclusion criteria were chosen. Then some markers will attach to the landmarks consist of C7 spinous process, and tragus, acromion process, T12 spinous process, coracoid process and T3 spinous process and photography will take. in the first session, the subject stand on the off WBV and two weeks later again she/he will stand on the ON Whole Body Vibration. After interventions, Photography will take again.
Settings and conduct
This study will be done in School of Rehabilitation if Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: female between 18-30 years old Rounded shoulder according to the Supine Test and shoulder protracted angle equal or more than 46 degree according to he photogrammetry, cardiovascular health. Exclusion criteria are: epilepsy, pregnancy, articular disorders, history of neurological disease such as vestibular and balance disorders, unhealed wound
Intervention groups
In the first session, the subject stand on the off Whole Body Vibration and two weeks later again she/he will stand on the ON Whole Body Vibration in the same position.
Main outcome variables
head horizontal alignment؛ distance between Acromion and 7th cervical vertebra ؛ Acromion horizontal alignment؛thoracic kyphosis؛ pectoralis minor lenght ؛ total distance of scapula.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130121012210N6
Registration date: 2018-01-26, 1396/11/06
Registration timing: registered_while_recruiting

Last update: 2018-01-26, 1396/11/06
Update count: 0
Registration date
2018-01-26, 1396/11/06
Registrant information
Name
Azadeh Shadmehr
Name of organization / entity
Teharn University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 8468
Email address
shadmehr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-15, 1396/10/25
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Immediate Effects of Whole Body Vibration on Photogrammetric Parameters of Shoulder Posture in Sagittal and Frontal Planes in Young Women with Rounded Shoulder Posture
Public title
The Immediate Effects of Whole Body Vibration on Shoulder Position in Young Women with Rounded Shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female between 18-30 years old Rounded shoulder according to the Supine Test and shoulder protracted angle equal or more than 46 degree according to he photogrammetry cardiovascular health
Exclusion criteria:
epilepsy pregnancy articular disorders history of neurological disease such as vestibular and balance disorders unhealed wound
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ettics Commitee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Bul, Poursina street
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-09-14, 1395/06/24
Ethics committee reference number
IR.TUMS.VCR.REC.1395.622

Health conditions studied

1

Description of health condition studied
rounded shoulder
ICD-10 code
M95.9
ICD-10 code description
Acquired deformity of musculoskeletal system, unspecified

Primary outcomes

1

Description
horizontal alignment of acromion
Timepoint
before and after the ON Whole Body Vibration and before and after the OFF Whole Body Vibration
Method of measurement
photogammetry

2

Description
head horizontal alignment
Timepoint
before and after the ON Whole Body Vibrationand before and after the OFF Whole Body Vibration
Method of measurement
photogammetry

3

Description
Pectoralis minor length
Timepoint
before and after the ON Whole Body Vibrationand before and after the OFF Whole Body Vibration
Method of measurement
photogammetry

4

Description
Distance of acromion to C7 spinous process
Timepoint
before and after the ON Whole Body Vibrationand before and after the OFF Whole Body Vibration
Method of measurement
photogammetry

5

Description
Thoracic Kyphosis
Timepoint
before and after the ON Whole Body Vibrationand before and after the OFF Whole Body Vibration
Method of measurement
photogammetry

6

Description
Total distance of skapula
Timepoint
before and after the ON Whole Body Vibrationand before and after the OFF Whole Body Vibration
Method of measurement
photogammetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Whole Body Vibration in ON mode
Category
Rehabilitation

2

Description
Intervention group: Whole Body Vibration in OّFF mode
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
َAzadeh Shadmehr
Street address
School of Rehabilitation, Piche Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
+98 21 7752 8468
Email
shadmehr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohammad ali Sahraian
Street address
Tehran University of Medical Sciences, Keshavarz Bul, Ghods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3627
Email
research@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
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
+98 21 7752 8468
Email
shadmehr@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Piche Shemiran, Enghelab Street Tehran تهران استان تهران کشور جمهوری اسلامی ایران کد پستی 1148965111
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
+98 21 7752 8468
Email
shadmehr@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Shadmehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
آدرس خیابان School of Rehabilitation, Piche Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7752 8468
Fax
+98 21 7752 8468
Email
shadmehr@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the Patients Data security
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Article Publication
When the data will become available and for how long
After Article Publication
To whom data/document is available
All of the People
Under which criteria data/document could be used
For Future Researches
From where data/document is obtainable
Azadeh Shadmehr shadmehr@tums.ac.ir
What processes are involved for a request to access data/document
with sending an Email
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