History
# Registration date Revision Id
3 2021-09-28, 1400/07/06 199504
2 2020-11-15, 1399/08/25 158939
1 2020-10-26, 1399/08/05 156207
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  • Protocol summary

    The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder impingement syndrome
    The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
    بررسی تاثیر تمرینات اصلاح پوسچر بر روی عملکرد و گشتاور ایزوکینتیک عضلات چرخاننده داخلی و خارجی شانه در ورزشکاران غیرحرفه ای مبتلا به سندروم گیرافتادگی شانه
    بررسی تاثیر تمرینات اصلاح پوسچر بر روی عملکرد و گشتاور ایزوکینتیک عضلات چرخاننده داخلی و خارجی شانه در ورزشکاران غیرحرفه ای مبتلا به سندروم گیرافتادگی داخلی شانه
    Clinical trial with a control group, with parallel groups, two-way blind, randomized, on 60 patients (2 groups of 30 people). Excel software rand function was used for randomization.
    Clinical trial with a control group, with parallel groups, one-way blind, randomized, on 22 patients (2 groups of 11 people). Excel software rand function was used for randomization.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده، روی 60 بیمار (2 گروه 30 نفری). برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، تصادفی شده، روی 22 بیمار (2 گروه 11 نفری). برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
    Intervention group: In this group, athletes undergo postural post-retraining exercises with breathing according to the protocol. Exercises for 6 weeks, which are done 5 days a week and once a day and 4 times each time. Control group: Exercise therapy is based on guidelines and is for comparison with the intervention group only.
    Intervention group: In this group, athletes undergo postural post-retraining exercises with breathing according to the protocol. Exercises for 6 weeks, which are done 5 days a week and once a day and 4 times each time. Control group: There is no intervention and it is only for comparison with the intervention group.
    گروه مداخله: در این گروه ورزشکاران طبق پروتکل تحت تمرین های بازآموزی پوسچرال، همراه با تنفس قرار می گیرند. تمرینات 6 هفته، که 5 روز در هفته و روزی 1بار و هر بار 4 مرتبه انجام می شود. گروه کنترل: تمرین درمانی طبق گایدلاین انجام می شود و فقط جهت مقایسه با گروه مداخله می باشد.
    گروه مداخله: در این گروه ورزشکاران طبق پروتکل تحت تمرین های بازآموزی پوسچرال، همراه با تنفس قرار می گیرند. تمرینات 6 هفته، که 5 روز در هفته و روزی 1بار و هر بار 4 مرتبه انجام می شود. گروه کنترل: هیچ گونه مداخله ای صورت نمی گیرد و فقط جهت مقایسه با گروه مداخله می باشد.
  • General information

    Double blinded
    Single blinded
    1
    1
    60
    22
    Remove the word "internal" from the title
    Sample size correction, how to blind from two sides to one side blind
    حذف کلمه "داخلی" از عنوان
    اصلاح حجم نمونه، نحوه کورسازی از دو سو کور به یک سو کور
    The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder impingement syndrome
    The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
    بررسی تاثیر تمرینات اصلاح پوسچر بر روی عملکرد و گشتاور ایزوکینتیک عضلات چرخاننده داخلی و خارجی شانه در ورزشکاران غیرحرفه ای مبتلا به سندروم گیرافتادگی شانه
    بررسی تاثیر تمرینات اصلاح پوسچر بر روی عملکرد و گشتاور ایزوکینتیک عضلات چرخاننده داخلی و خارجی شانه در ورزشکاران غیرحرفه ای مبتلا به سندروم گیرافتادگی داخلی شانه
    The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder impingement syndrome
    The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
    بررسی تاثیر تمرینات اصلاح پوسچر بر روی عملکرد و گشتاور ایزوکینتیک عضلات چرخاننده داخلی و خارجی شانه در ورزشکاران غیرحرفه ای مبتلا به سندروم گیرافتادگی شانه
    بررسی تاثیر تمرینات اصلاح پوسچر بر روی عملکرد و گشتاور ایزوکینتیک عضلات چرخاننده داخلی و خارجی شانه در ورزشکاران غیرحرفه ای مبتلا به سندروم گیرافتادگی داخلی شانه
    Participants and researchers or outcome assessors are unaware of the allocation of study groups.
    Participants are unaware of the allocation of study groups.
    شرکت کنندگان و محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاع هستند.
    شرکت کنندگان از تخصیص گروههای مطالعه بی اطلاع هستند.
  • Intervention groups

    #1
    Control group: Exercise therapy is based on guidelines and is for comparison with the intervention group only.
    Control group: There is no intervention and it is only for comparison with the intervention group.
    گروه کنترل: تمرین درمانی بر اساس گایدلاین انجام می شود و فقط جهت مقایسه با گروه مداخله می باشد.
    گروه کنترل: هیچ گونه مداخله ای صورت نمی گیرد و فقط جهت مقایسه با گروه مداخله می باشد.

Protocol summary

Study aim
The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
Design
Clinical trial with a control group, with parallel groups, one-way blind, randomized, on 22 patients (2 groups of 11 people). Excel software rand function was used for randomization.
Settings and conduct
Neuromuscular Rehabilitation Research Center
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-35 years; History of back and shoulder pain and shoulder entrapment in the past month; A non-professional athlete who exercises an average of 6 to 8 hours per week. Exclusion criteria: People with a body mass index of more than 30; Previous history of shoulder surgery; Performed shoulder physiotherapy in the last 3 months; Shoulder deformation; Osteoporosis.
Intervention groups
Intervention group: In this group, athletes undergo postural post-retraining exercises with breathing according to the protocol. Exercises for 6 weeks, which are done 5 days a week and once a day and 4 times each time. Control group: There is no intervention and it is only for comparison with the intervention group.
Main outcome variables
Muscles performance level; Muscle strength.

General information

Reason for update
Sample size correction, how to blind from two sides to one side blind
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025732N58
Registration date: 2020-10-26, 1399/08/05
Registration timing: registered_while_recruiting

Last update: 2021-09-29, 1400/07/07
Update count: 2
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
Public title
The effect of postural restoration exercises on function and isokinetic torque of shoulder external and internal rotator muscles in amature athletes with shoulder internal impingement syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-35 years History of back and shoulder pain and shoulder entrapment in the past month A non-professional athlete who exercises an average of 6 to 8 hours per week
Exclusion criteria:
People with a body mass index of more than 30 Previous history of shoulder surgery Performed shoulder physiotherapy in the last 3 months Shoulder deformation Osteoporosis
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables. Randomized permutation blocks (block 2). Using Excel software to generate random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.SEMUMS.REC.1399.077

Health conditions studied

1

Description of health condition studied
Internal shoulder impingement syndrome
ICD-10 code
M75.40
ICD-10 code description
Impingement syndrome of unspecified shoulder

Primary outcomes

1

Description
Muscles performance level
Timepoint
Before the intervention, after the end of the exercise therapy sessions, one month after the end of the exercise therapy sessions.
Method of measurement
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)

2

Description
Muscle strength
Timepoint
Before the intervention, after the end of the exercise therapy sessions, one month after the end of the exercise therapy sessions.
Method of measurement
Biodex Pro-4, Isokinetic Shirley, New York‬‬ ‫‪

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, athletes undergo postural post-retraining exercises with breathing according to the protocol. Exercises for 6 weeks, which are done 5 days a week and once a day and 4 times each time.
Category
Rehabilitation

2

Description
Control group: There is no intervention and it is only for comparison with the intervention group.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Atefeh Aminianfar
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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