Protocol summary

Study aim
Comparing of the effect of eight weeks postural corrective based childhood poetry training with and without common usual corrective exercises program on Forward head and shoulder deformities posture of 8 to 10 years old students
Design
Intervention clinical trial without control group, with parallel groups, single-blind, randomized, performed on 45 students
Settings and conduct
The place where the study is carried out is in Shohada Qamiyeh Elementary School. Health protocols were followed and according to the World Health Notice, children aged 8 to 10 years do not have special restrictions regarding diseases and vaccines are not mandatory. In conducting the study and data analysis, the researcher and the students and the analyst were blinded.
Participants/Inclusion and exclusion criteria
Entry requirements Complete satisfaction of students' parents Students aged 8 to 10 years Students do not have a specific illness There are no other abnormalities in other parts of the student's body No history of effective surgery Have a Forward head deformities greater than 42 degrees and Forward shoulder deformities greater than 52 degrees Students should be within the range of normal body mass Exit conditions Withdrawal from research Absence of more than 2 training sessions Absence in post-test Getting a specific disease during different stages of research
Intervention groups
Pastural poetry group, which is formed by teaching corrective movements related to the forward head and shoulder in the language of poetry. The group of corrective exercises is formed by doing the usual corrective movements. Pastural poetry group and corrective exercises in a combined form that have both trainings.
Main outcome variables
Correction of Forward head and shoulder deformities . Preventing the spread of physical abnormalities from childhood.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171205037757N2
Registration date: 2022-07-09, 1401/04/18
Registration timing: retrospective

Last update: 2022-07-09, 1401/04/18
Update count: 0
Registration date
2022-07-09, 1401/04/18
Registrant information
Name
Marzieh Mokhtari Karchegani
Name of organization / entity
The University of tehran
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 8601
Email address
mokhtari.marzieh.1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-30, 1401/03/09
Expected recruitment end date
2022-06-19, 1401/03/29
Actual recruitment start date
2022-06-01, 1401/03/11
Actual recruitment end date
2022-06-20, 1401/03/30
Trial completion date
2022-08-21, 1401/05/30
Scientific title
Comparing of the effect of eight weeks postural corrective based childhood poetry training with and without common usual corrective exercises program on Forward head and shoulder deformities posture of 8 to 10 years old students
Public title
The effect of postural poetry on improving Forward head and shoulder deformities posture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Complete satisfaction of students' parents Students aged 8 to 10 years Students do not have a specific illness There are no other abnormalities in other parts of the student's body No history of effective surgery Have a Forward head deformities greater than 42 degrees and Forward shoulder deformities greater than 52 degrees Students should be within the range of normal body mass
Exclusion criteria:
Withdrawal from research Absence of more than 2 training sessions Absence in post-test Getting a specific disease during different stages of research
Age
From 8 years old to 10 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher has by no means interfered in test neither in pre-test before exercise or post-test after exercise as the tests were given by individuals who had no clue about the plan.the participants were not alert of test application as well and just acted to instruction.The person who analyzed the data did not know about the study and generally looked at the data
Placebo
Not used
Assignment
Parallel
Other design features
Use of health poetry book and prevention of children's physical disorders

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, Faculty of Physical Education and Sports Sciences, University of Tehra
Street address
Faculty of Physical Education and Sports Sciences,North Kargar Street
City
Tehran
Province
Tehran
Postal code
1417935771
Approval date
2022-05-30, 1401/03/09
Ethics committee reference number
IR.UT.SPORT.REC.1401.002

Health conditions studied

1

Description of health condition studied
Forward head and shoulder deformities
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Forward head angle
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Photogrammetry

2

Description
Forward shoulder angle
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Photogrammetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Postural correction with postural poetry (n=15)
Category
Rehabilitation

2

Description
Intervention group: Posture correction with corrective exercises (n=15)
Category
Rehabilitation

3

Description
Intervention group: Postural correction with postural poetry and corrective exercises(n=15)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Ghaemieh School in Isfahan
Full name of responsible person
َAَli momani
Street address
Next to Shohada Mosque, After Asyab Alley, The end of Ghaemieh Street
City
Isfahan
Province
Isfehan
Postal code
8178676811
Phone
+98 31 3780 5032
Email
Info@novinweb.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Reza Rajabi
Street address
Faculty of Physical Education and Sports Sciences,Kargar Shomali Street
City
Tehran
Province
Tehran
Postal code
1417935771
Phone
+98 21 8835 1730
Email
Ethicsresearch.Sport@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Student
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Marzieh Mokhtari Karchegani
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Street address
No. 76, Ershad dead end, Nastooh St
City
Esfahan
Province
Isfehan
Postal code
8174784986
Phone
+98 31 3775 8601
Email
Mokhtari.Marzieh.1371@Gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Marzieh Mokhtari Karchegani
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
No. 76, Ershad dead end, Nastooh St
City
Esfahan
Province
Isfehan
Postal code
8174784986
Phone
+98 31 3775 8601
Email
Mokhtari.Marzieh.1371@Gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Marzieh Mokhtari Karchegani
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
No. 76, Ershad dead end, Nastooh St
City
Esfahan
Province
Isfehan
Postal code
8174784986
Phone
+98 31 3775 8601
Email
Mokhtari.Marzieh.1371@Gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
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
No - There is not a plan to make this available
Title and more details about the data/document
Data and documentation can be shared, but with unidentifiable individuals and private information for subjects
When the data will become available and for how long
Starting data access 1 year after printing results
To whom data/document is available
Researchers in this field are allowed to act for documentation
Under which criteria data/document could be used
Only the type of analysis that can be done in the research can be redefined
From where data/document is obtainable
Mokhtari.Marzieh.1371@Gmail.com
What processes are involved for a request to access data/document
When the applicant submits a document for his / her work area in relation to the subject matter of the thesis, and if the request is reasonable and the commitment not to misuse the data of this research, the data will be sent to him within 1 week of work.
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