History
# Registration date Revision Id
4 2019-05-13, 1398/02/23 91336
3 2019-02-19, 1397/11/30 80048
2 2019-01-23, 1397/11/03 77051
1 2018-10-26, 1397/08/04 64634
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  • Protocol summary

    to study the changes in the alignment (position of the scapula, head, shoulders and thoracic spine) and the electromyography activity of the selected muscles (upper , middle and lower trapezius, serratus anterior) and the movement patterns (Scapulohumeral rhythm and neck flexion) based on a comprehensive approach in the assessment processes, the design of their corrective exercises and their effectiveness in men with the UCS before and after an 8-week the CCEP, and 4 weeks detraining after it, examine the sustainability of the changes.
    To study the changes in the alignment (position of the scapula, head, shoulders and thoracic spine) and the electromyography activity of the selected muscles (upper , middle and lower trapezius, serratus anterior) and the movement patterns (Scapulohumeral rhythm and neck flexion) based on a comprehensive approach in the assessment processes, the design of their corrective exercises and their effectiveness in men with the UCS before and after an 8-week the CCEP, and 4 weeks detraining after it, examine the sustainability of the changes.
    single-blind randomized controlled trial
    Single-blind randomized controlled trial
    کارآزمایی بالینی دارای گروه کنترل یک سویه کور
    کارآزمایی بالینی دارای گروه کنترل یک سویه کور، تصادفی شده
  • General information

    2018-07-23, 1397/05/01
    2018-12-22, 1397/10/01
    2018-10-23, 1397/08/01
    2019-03-21, 1398/01/01
    the students of the University of Tehran, Iran.
    Participants who have all symptoms of UCS
    complete the written consent form
    18 to 28 years of age
    The students of the University of Tehran, Iran.
    Participants who have all symptoms of UCS
    Complete the written consent form
    18 to 28 years of age
    don’t complete the corrective exercise program
    have lack of interest in continuing the research program
    have physical activity and sports
    have any visible malalignment in the pelvis and lower extremities
    have pathological signs
    have a history of fracture, surgery, or joint diseases in the spine, shoulder and pelvis
    have a body weight outside the normal range
    Don’t complete the corrective exercise program
    Have lack of interest in continuing the research program
    Have physical activity and sports
    Have any visible malalignment in the pelvis and lower extremities
    Have pathological signs
    Have a history of fracture, surgery, or joint diseases in the spine, shoulder and pelvis
    Have a body weight outside the normal range
    In order to randomly assign the subjects to the intervention and control groups, one number was considered for each subject. The numbers were randomly assigned to two groups using a random number table. To conceal numbers in each group, they were written on paper, and each one was kept in a numbered sealed, opaque envelope.
    In order to randomly assign the subjects to the intervention and control groups, one number is considered for each subject. The numbers are randomly assigned to two groups using a random number table. To conceal numbers in each group, they are written on paper, and each one is kept in a numbered sealed, opaque envelope.
    به منظور اختصاص تصادفی آزمودنی ها به گروه های مداخله و کنترل، برای هر آزمودنی یک عدد در نظر گرفته شد، اعداد بصورت تصادفی و با استفاده از جدول اعداد تصادفی بین دو گروه تقسیم شدند. جهت پنهان سازی اعداد در هر گروه بر روی کاغذ نوشته شد، و هر یک در یک پاکت مهر و موم شده مات جداگانه نگه داشته میشد. از هر آزمودنی خواسته میشد تا یکی از پاکت نامه ها را انتخاب کند و بر اساس عدد در یکی از گروه ها قرار می گرفت.
    به منظور اختصاص تصادفی آزمودنی ها به گروه های مداخله و کنترل، برای هر آزمودنی یک عدد در نظر گرفته میشود، اعداد بصورت تصادفی و با استفاده از جدول اعداد تصادفی بین دو گروه تقسیم میشوند. جهت پنهان سازی اعداد در هر گروه بر روی کاغذ نوشته میشود، و هر یک در یک پاکت مهر و موم شده مات جداگانه نگه داشته میشود. از هر آزمودنی خواسته میشود تا یکی از پاکت نامه ها را انتخاب کند و بر اساس عدد در یکی از گروه ها قرار می گیرد.
  • Health conditions studied

    #1
    upper crossed syndrome
    Upper crossed syndrome
  • Primary outcomes

    #1
    position of Scapula
    Position of Scapula
    before intervention, 8 and 12 weeks after starting the intervention
    Before intervention, 8 and 12 weeks after starting the intervention
    #2
    before intervention, 8 and 12 weeks after starting the intervention
    Before intervention, 8 and 12 weeks after starting the intervention
    photogrammetery method
    Photogrammetery method
    #3
    before intervention, 8 and 12 weeks after starting the intervention
    Before intervention, 8 and 12 weeks after starting the intervention
    #4
    before intervention, 8 and 12 weeks after starting the intervention
    Before intervention, 8 and 12 weeks after starting the intervention
  • Secondary outcomes

    #1
    before intervention and 8,12 weeks after starting the intervention
    Before intervention and 8,12 weeks after starting the intervention
    dynamic scapular dyskinesis tests
    Dynamic scapular dyskinesis tests
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Mohammad Bayattork
    Full name of responsible person - Persian: محمد بیات ترک
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 88
    Area of specialty/work title - English: corrective exercises
    Area of specialty/work title - Persian: حرکات اصلاحی
    Street address - English: North Kargar
    Street address - Persian: کارگر شمالی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417614418
    Phone: +98 21 8835 1730
    Mobile: +98 915 552 1005
    Fax:
    Email: mohammadbayat82@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Mohammad Bayattork
    Full name of responsible person - Persian: محمد بیات ترک
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 88
    Area of specialty/work title - English: Corrective exercises
    Area of specialty/work title - Persian: حرکات اصلاحی
    Street address - English: North Kargar
    Street address - Persian: کارگر شمالی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417614418
    Phone: +98 21 8835 1730
    Mobile: +98 915 552 1005
    Fax:
    Email: mohammadbayat82@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: University of tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Mohammad Bayattork
    Full name of responsible person - Persian: محمد بیات ترک
    Position - English: student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 88
    Area of specialty/work title - English: corrective exercises
    Area of specialty/work title - Persian: حرکات اصلاحی
    Street address - English: North Kargar
    Street address - Persian: کارگر شمالی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417614418
    Phone: +98 21 8835 1730
    Mobile: +98 915 552 1005
    Fax:
    Email: mohammadbayat82@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: University of tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Mohammad Bayattork
    Full name of responsible person - Persian: محمد بیات ترک
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 88
    Area of specialty/work title - English: Corrective exercises
    Area of specialty/work title - Persian: حرکات اصلاحی
    Street address - English: North Kargar
    Street address - Persian: کارگر شمالی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417614418
    Phone: +98 21 8835 1730
    Mobile: +98 915 552 1005
    Fax:
    Email: mohammadbayat82@gmail.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: University of tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Mohammad Bayattork
    Full name of responsible person - Persian: محمد بیات ترک
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 88
    Area of specialty/work title - English: corrective exercises
    Area of specialty/work title - Persian: حرکات اصلاحی
    Street address - English: North Kargar
    Street address - Persian: تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417614418
    Phone: +98 21 8835 1730
    Mobile: +98 915 552 1005
    Fax:
    Email: mohammadbayat82@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: University of Tehran
    Name of organization / entity - Persian: دانشگاه تهران
    Full name of responsible person - English: Mohammad Bayattork
    Full name of responsible person - Persian: محمد بیات ترک
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: master
    Area of specialty/work: 88
    Area of specialty/work title - English: Corrective exercises
    Area of specialty/work title - Persian: حرکات اصلاحی
    Street address - English: North Kargar
    Street address - Persian: تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417614418
    Phone: +98 21 8835 1730
    Mobile: +98 915 552 1005
    Fax:
    Email: mohammadbayat82@gmail.com
    Web page address:

Protocol summary

Study aim
To study the changes in the alignment (position of the scapula, head, shoulders and thoracic spine) and the electromyography activity of the selected muscles (upper , middle and lower trapezius, serratus anterior) and the movement patterns (Scapulohumeral rhythm and neck flexion) based on a comprehensive approach in the assessment processes, the design of their corrective exercises and their effectiveness in men with the UCS before and after an 8-week the CCEP, and 4 weeks detraining after it, examine the sustainability of the changes.
Design
Single-blind randomized controlled trial
Settings and conduct
A single-blinded randomized, controlled trial comparing a 3 times per week group exercise intervention with a control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-athletic male students residing in the dormitory of Tehran University who are aged 18 to 28 years old. having scapular dyskinesis. forward head and shoulder degrees more than 46 and 52 respectively, and increased thoracic kyphosis more than 42. complete the written consent form. Exclusion criteria: History of disease and fracture, abnormalities in the lower extremities.
Intervention groups
The intervention group includes those with the upper crossed syndrome who receive the intervention of a comprehensive corrective exercise program. The control group also includes people with the upper crossed syndrome who do not receive any training intervention and follow their daily activities.
Main outcome variables
The alignment of head and thoracic spine with selected muscle activation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181004041232N1
Registration date: 2018-10-26, 1397/08/04
Registration timing: prospective

Last update: 2019-01-27, 1397/11/07
Update count: 3
Registration date
2018-10-26, 1397/08/04
Registrant information
Name
Mohammad Bayattork
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8846 4538
Email address
bayattork@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a Comprehensive Corrective Exercises Program (CCEP) and subsequent detraining on alignment, muscle activation and movement pattern in men with upper crossed syndrome
Public title
Comprehensive Corrective Exercises and upper crossed syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The students of the University of Tehran, Iran. Participants who have all symptoms of UCS Complete the written consent form 18 to 28 years of age
Exclusion criteria:
Don’t complete the corrective exercise program Have lack of interest in continuing the research program Have physical activity and sports Have any visible malalignment in the pelvis and lower extremities Have pathological signs Have a history of fracture, surgery, or joint diseases in the spine, shoulder and pelvis Have a body weight outside the normal range
Age
From 18 years old to 28 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Actual sample size reached: 22
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the subjects to the intervention and control groups, one number is considered for each subject. The numbers are randomly assigned to two groups using a random number table. To conceal numbers in each group, they are written on paper, and each one is kept in a numbered sealed, opaque envelope.
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
Ethics committee of Tehran University
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2017-08-28, 1396/06/06
Ethics committee reference number
IR.ut.Rec.1395026

Health conditions studied

1

Description of health condition studied
Upper crossed syndrome
ICD-10 code
M40.04
ICD-10 code description
Postural kyphosis, thoracic region

Primary outcomes

1

Description
Position of Scapula
Timepoint
Before intervention, 8 and 12 weeks after starting the intervention
Method of measurement
Inclinometer

2

Description
Head alignment
Timepoint
Before intervention, 8 and 12 weeks after starting the intervention
Method of measurement
Photogrammetery method

3

Description
Thoracic kyphosis angle
Timepoint
Before intervention, 8 and 12 weeks after starting the intervention
Method of measurement
Flexicurve

4

Description
Electromyography of selected muscles
Timepoint
Before intervention, 8 and 12 weeks after starting the intervention
Method of measurement
Electromyography device

Secondary outcomes

1

Description
Scapular dyskinesis
Timepoint
Before intervention and 8,12 weeks after starting the intervention
Method of measurement
Dynamic scapular dyskinesis tests

Intervention groups

1

Description
Intervention group: The intervention group will receive comprehensive corrective exercises under supervision and 3 sessions a week. The duration of the intervention period is 8 weeks.
Category
Prevention

2

Description
Control group: There is no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Tehran
Full name of responsible person
Mohammad bayattork
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
Mohammadbayat82@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Mohammad Bayattork
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
mohammadbayat82@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tehran
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
University of Tehran
Full name of responsible person
Mohammad Bayattork
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective exercises
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
mohammadbayat82@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of tehran
Full name of responsible person
Mohammad Bayattork
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective exercises
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
mohammadbayat82@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mohammad Bayattork
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective exercises
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
mohammadbayat82@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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