Protocol summary

Study aim
Comparing the effect of two kind of the current and NASM corrective exercises protocols on the dynamic Q angle ‚ position sense and function in girl students with Genu Valgum
Design
Clinical trial with control group, with parallel, single blind, randomized groups
Settings and conduct
Forty five girl students with Genu Valgum with aged 12-16, were voluntarily included in the study and divided into two experimental groups (current and NASM), and one control group. The experimental groups received current and NASM corrective exercises for eight weeks. In the pre- and post-tests, the dynamic Q angle, the positional sense of the knee joint and function were examined
Participants/Inclusion and exclusion criteria
Female students aged 16-12 years that have genovalgum
Intervention groups
current and NASM corrective exercises and control group
Main outcome variables
dynamic Q angle, the positional sense of the knee joint, function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046035N1
Registration date: 2020-04-15, 1399/01/27
Registration timing: retrospective

Last update: 2020-04-15, 1399/01/27
Update count: 0
Registration date
2020-04-15, 1399/01/27
Registrant information
Name
Hossein Shahrokhi
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2756
Email address
h.shahrokhi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-07-06, 1398/04/15
Trial completion date
2019-11-06, 1398/08/15
Scientific title
Comparing the effect of two kind of the current and NASM corrective exercises protocols on the dynamic Q angle ‚ position sense and function in girl students with Genu Valgum
Public title
the effect of two kind of the current and NASM corrective exercises protocols on the dynamic Q angle ‚ position sense and function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Student Genu Valgum age between 12 - 16
Exclusion criteria:
Age
From 12 years old to 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method was used that in this method for generate random sequences "Random allocation software" was used. Then, central randomization method was used to allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects were 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
Sport sciences research institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-12-04, 1398/09/13
Ethics committee reference number
IR.SSRI.REC.1398.590

Health conditions studied

1

Description of health condition studied
Genu Valgum
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Genovalgum is one of the deformities of the knee in which the knees approach each other and the internal ankles move away from each other.
Timepoint
At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention
Method of measurement
Camera , Dartfish software, tape meter, stopwatch

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: current corrective exercises
Category
Rehabilitation

2

Description
Intervention group: NASM corrective exercises
Category
Rehabilitation

3

Description
Control group: control
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Karaj Education
Full name of responsible person
Narjes Abdollahi Natanzi
Street address
Alborz Province, Karaj, Azimieh, Mikhak
City
Karaj
Province
Alborz
Postal code
13474593489
Phone
+98 26 3252 8384
Email
n.abdollahinatanzi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Raja university
Full name of responsible person
hadi miri
Street address
novrizian, motahhari bolv
City
قزوین
Province
Qazvin
Postal code
95834-34148
Phone
+98 28 3367 7101
Email
hd.miri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Author
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
Hakin Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
sport injury and corrective exercise
Street address
Hakim sabzevari university - tohidshahr - Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Email
h.shahrokhi@hsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
tohidshahr - hakim sabzevari university
City
sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Email
h.shahrokhi@hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari university
Full name of responsible person
Hossein Shahrokhi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
tohidshahr - hakim sabzevari university
City
sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Email
h.shahrokhi@hsu.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period one year after printing the results
To whom data/document is available
Data will be available to academic and scientific researchers
Under which criteria data/document could be used
Any kind of functional analysis on the submitted data is allowed
From where data/document is obtainable
by Email: h.shahrokhi@hsu.ac.ir
What processes are involved for a request to access data/document
by Email: h.shahrokhi@hsu.ac.ir and the reason for using the documents
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