Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
هدف از تحقیق بررسی تاثیر تقویت ایزوله عضلات آبداکتور و اکسترنال روتاتور هیپ بر بهبود ولگوس زانو طی فرود تک پا می باشد
هدف از تحقیق بررسی تاثیر تقویت ایزوله عضلات آبداکتور و اکسترنال روتاتور هیپ بر ولگوس زانو طی فرود تک پا می باشد
هدف از تحقیق بررسی تاثیر تقویت ایزوله عضلات آبداکتور و اکسترنال روتاتور هیپ بر بهبود ولگوس زانو طی فرود تک پا می باشد
General information
Not blinded
Double blinded
notbldoubl
1
1
1
1
1
1
1
1
empty
Provide more information about randomization
Provide more information about randomization
empty
ارائه اطلاعات بیشتر درخصوص نحوه تصادفی سازی
ارائه اطلاعات بیشتر درخصوص نحوه تصادفی سازی
participated in an ACL injury prevention program
participated in an ACL injury prevention program
knee valgus angle less than 8 degree during jump-landing task
participated in an ACL injury prevention program knee valgus angle less than 8 degree during jump-landing task
شرکت کردن در برنامه های پیشگیری از آسیب رباط متقاطع قدامی زانو
شرکت کردن در برنامه های پیشگیری از آسیب رباط متقاطع قدامی زانو
زاویه ولگوس کمتر از 9 درجه
شرکت کردن در برنامه های پیشگیری از آسیب رباط متقاطع قدامی زانو زاویه ولگوس کمتر از 9 درجه
Random allocation rule.In this way, the researchers selected thirty-two subjects and assigned in a randomly fashion in two equal groups.
Randomization of participants was performed through drawing opaque envelopes numbered 1 or 2 by an independent coordinator, not otherwise involved in the study, who created an allocation sequence that assigned participants to the training or control groups.
RandomRandomization of participants was performed through drawing opaque envelopes numbered 1 or 2 by an independent coordinator, not otherwise involved in the study, who created an allocation rule.In this way,sequence that assigned participants to the researchers selected thirty-two subjects and assigned in a randomly fashion in two equaltraining or control groups.
قانون تخصیص تصادفی. در این روش محققان سی و دو نفر را انتخاب و بصورت تصادفی به دو گروه مساوی تقسیم کردند
تصادفی سازی با استفاده از بیرون کشیدن عدد یک یا دو از داخل پاکت توسط یک نفر مستقل از طرح تحقیق و قرار دادن افراد در گروه های کنترل و تجربی صورت گرفت
قانون تخصیص تصادفی. سازی با استفاده از بیرون کشیدن عدد یک یا دو از داخل پاکت توسط یک نفر مستقل از طرح تحقیق و قرار دادن افراد در این روش محققان سیگروه های کنترل و دو نفر را انتخاب و بصورت تصادفی به دو گروه مساوی تقسیم کردندتجربی صورت گرفت
Participants and research assistants (trainers and data analyzer) were blind to group allocation. Group allocation prepared by an independent coordinator were not associated with the rendition of the exercise program. Each groups had independed trainer, not otherwise involved in the study.
Participants and research assistants (trainers and data analyzer) were blind to group allocation. Group allocation prepared by an independent coordinator were not associated with the rendition of the exercise program. Each groups had independed trainer, not otherwise involved in the study.
آزمودنی ها و همکاران تحقیق (مربیان و آنالیز کننده داده) نسبت به گروه بندی کور بودند. گروه بندی توسط فردی اجرا شد که در روند اجرای تمرینات نقشی نداشت. هر گروه نیز دارای مربی جداگانه ای بود که در فرایند طرح تحقیق دخیل نبود.
آزمودنی ها و همکاران تحقیق (مربیان و آنالیز کننده داده) نسبت به گروه بندی کور بودند. گروه بندی توسط فردی اجرا شد که در روند اجرای تمرینات نقشی نداشت. هر گروه نیز دارای مربی جداگانه ای بود که در فرایند طرح تحقیق دخیل نبود.
Protocol summary
Study aim
To investigate the effect of isolated hip abductor and external rotator muscle strengthening on dynamic knee valgus during single-leg landing.
Design
Two arm parallel group randomized Clinical Trial with blinded outcome assessment
Settings and conduct
Thirty-two males with knee valgus angle more than 9 degree were randomized into a training (n=16) or control group (n=16). The training group carried out 8 weeks of bilateral hip abductor and external rotator strengthening 3 times per week. Pre and post-test hip strength were measured with isokinetic dynamometer (Kin-Com) and motion capture data were collected during 3 single-leg landing trials. Pelvis, hip and knee angles were estimated using QTM and Visual 3D software. the study was carried out in Azad Republic university's laboratory.
Participants/Inclusion and exclusion criteria
To be considered for the study, subjects had to be male (age 19 to 23) and show knee valgus angle more than 8 degrees during jump-landing task . All subjects had a history of at least 2 years participation in/or football, futsal, handball and volleyball, no history of lower extremity surgery, no regular hip muscles strengthening program, no participation in an ACL injury prevention program, no lower extremity injury within 6 months before the study, no limitation in ankle dorsiflexion range of motion and no obvious misalignment in lower extremity
Intervention groups
Intervention group: 8 weeks of bilateral isolated hip abductor and external rotator strengthening exercise
Main outcome variables
Knee valgus angle; hip muscle strength
General information
Reason for update
Provide more information about randomization
Acronym
IRCT registration information
IRCT registration number:IRCT20190511043552N1
Registration date:2019-09-28, 1398/07/06
Registration timing:retrospective
Last update:2022-03-22, 1401/01/02
Update count:1
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Mahdi Safari Bak
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 51 3365 5977
Email address
m.safari950@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-07-16, 1398/04/25
Actual recruitment start date
2019-07-06, 1398/04/15
Actual recruitment end date
2019-07-09, 1398/04/18
Trial completion date
2019-09-19, 1398/06/28
Scientific title
The effects of isolated hip abductor and external rotator muscle strengthening on dynamic knee valgus during single leg landing
Public title
The effects hip muscles strengthening on dynamic knee valgus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
subjects had to be male (age 19 to 23)
shown knee valgus angle more than 8 degree during jump-landing task
subjects had no history of lower extremity surgery
no regular hip muscles strengthening program
no lower extremity injury within 6 months before the study
no limitation in ankle dorsiflexion range of motion
no obvious misalignment in lower extremity
Exclusion criteria:
participated in an ACL injury prevention program
knee valgus angle less than 8 degree during jump-landing task
Age
From 20 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of participants was performed through drawing opaque envelopes numbered 1 or 2 by an independent coordinator, not otherwise involved in the study, who created an allocation sequence that assigned participants to the training or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and research assistants (trainers and data analyzer) were blind to group allocation. Group allocation prepared by an independent coordinator were not associated with the rendition of the exercise program. Each groups had independed trainer, not otherwise involved in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National committee for Ethics in Biomedical Research
Street address
Azadi sq, Isfahan university, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.UI.REC.1398.023
Health conditions studied
1
Description of health condition studied
knee valgus angle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
knee valgus angle: medial knee deviation
Timepoint
measurement at the baseline and after eight week exercise
Method of measurement
Visual 3D motion analysis software
2
Description
hip muscles strength
Timepoint
measurement at the baseline and after eight week exercise
Method of measurement
isokinetic dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Eight weeks of Isolated hip abductor and external rotator strengthening 3 times per week.
Category
Prevention
2
Description
Control group: daily activity
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khavaran university
Full name of responsible person
Mohsen Behrad
Street address
No 12, Shahid Hassani Ave, Fallahi, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9184168619
Phone
+98 51 3523 0690
Email
info@mail.khi.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Isfahan
Full name of responsible person
Dr. Minasian
Street address
Isfahan university, Azadi sq, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2288
Email
research.deputy@dean.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Isfahan
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
The Isfahan university
Full name of responsible person
Mahdi Safaribak
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Sport injury and corrective exercise
Street address
Sport science faculty, Isfahan university, Azadi sq, Isfahan
City
Isfahan
Province
Isfehan
Postal code
09153147471
Phone
+98 513655977
Email
m.safari950@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Isfahan university
Full name of responsible person
Khalil Khayambashi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Sport science faculty, Isfahan university, Azadi square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2127
Email
dr.khayam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The Isfahan university
Full name of responsible person
Mahdi Safaribak
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Sport injury and corrective exercise
Street address
Sport science faculty, Isfahan university, Azadi sq, Isfahan
City
Isfahan
Province
Isfehan
Postal code
9153147271
Phone
+98 513655977
Email
m.safari950@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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The entire data of individual is publicly available after it will be unidentifiable
When the data will become available and for how long
get started since 2019
To whom data/document is available
All researchers in sport medicine and sport coaches
Under which criteria data/document could be used
There are no special condition and everyone can have access