Protocol summary

Study aim
General purpose: The effect of eight weeks of corrective exercises on the loss of navigation, proprioception, balance and performance of 10-13 year old girls with flat feet with and without crossed knees
Design
To determine the sample size using G-power software, in intervention research, if we consider the level of α as 0.05 and the value of β as 0.20, according to the effect size of the exercise program and having two groups, the number of samples 34 is enough. 40 samples are considered with the possibility of statistical drop.
Settings and conduct
The current study is an interventional type of clinical trial with a pre-test - post-test design. The statistical population of the current research will be all elementary school female students with flat flexible soles with the age range of 10 to 13 years in Tabriz city who have not reached the age of puberty.
Participants/Inclusion and exclusion criteria
The inclusion criteria include having flat, flexible soles in both feet (level two flat feet and navicular drop more than 10 mm), having crossed knee deformity (degree two) and the exclusion criteria include people with bracket knee and backward knee deformities.
Intervention groups
Two groups of 20 people included (20 people with flat soles without other abnormalities in the lower limbs and 20 people with flat soles with crossed knee deformities)
Main outcome variables
After the present research, physical education teachers in schools in the implementation of physical education lessons and sports bells and physical fitness trainers and correctional movement specialists in correctional clinic centers should pay attention to the results of the research.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240518061829N1
Registration date: 2024-05-25, 1403/03/05
Registration timing: registered_while_recruiting

Last update: 2024-05-25, 1403/03/05
Update count: 0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Mehrnaz Zolfeghary
Name of organization / entity
Urmia University
Country
Iran (Islamic Republic of)
Phone
+98 41 3741 1571
Email address
zolfegharym@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of corrective exercises on the posture of pes planus, proprioception, balance and performance of girls with and without geno valgum
Public title
Comparison of the effect of corrective exercises on the posture of pes planus, proprioception, balance and performance of girls with and without geno valgum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Completing the voluntary company consent form 10 to 13-year-old elementary school girl students Having smooth, flexible soles in both feet (grade two flat soles and navicular drop more than 10 mm) Having crossed knee deformity (second degree) Normal body mass index is between 18.5 and 24.9 Not participating in any other experimental or treatment program during the trial Absence of cardiovascular diseases, diabetes, asthma Absence of knee brace and backward knee abnormalities Absence of pain, physical disability, orthopedic problem Absence of abnormal range of motion of lower limb joints No history of previous injuries and muscle disorders in the lower limbs
Exclusion criteria:
People with cardiovascular diseases, diabetes, asthma, deformities of bow-legs and Genu recurvatum knee Presence of pain, physical disability, medical prohibition or orthopedic problem Abnormal range of motion of lower limb joints Having a history of previous injuries and muscle disorders in the lower limbs Absence of more than 2 sessions in practice sessions Dissatisfaction, withdrawal or non-cooperation
Age
From 10 years old to 13 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Urmia University
Street address
Nazlo, Urmia University, Faculty of Physical Education
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.URMIA.REC.1402.030

Health conditions studied

1

Description of health condition studied
students with flat feet and geno valgum
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Loss of navigation, Proprioception, Balance and Performance
Timepoint
The effect of eight weeks of corrective exercises on the loss of navigation, proprioception, balance and performance
Method of measurement
Brody method- goniometer-stork balance tes-Y balance test- Sargent's jump

Secondary outcomes

1

Description
flat feet - geno valgum
Timepoint
The effect of eight weeks of corrective exercises
Method of measurement
Evaluation of grade 2 flexible flat soles by pedography method - crossed knee from calipers

Intervention groups

1

Description
Intervention group: The first intervention group: 20 people with flat soles without other abnormalities in the lower limbs - the second intervention group: 15 people with flat soles with crossed knee deformities
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Urmia University
Full name of responsible person
Mehrnaz Zolfeghari
Street address
Kilometer 11, Cero Road
City
ارومیه
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
info@urmia.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University
Full name of responsible person
Sajjad Roshni
Street address
Kilometer 11 of Cero Road - Urmia University
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
info@urmia.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University
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
Urmia University
Full name of responsible person
Sajjad Roshni
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports pathology and corrective exercises
Street address
Km 11 cero Road - Urmia University - Faculty of Sports Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
srowshani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University
Full name of responsible person
sajjad roshani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports pathology and corrective exercises
Street address
Km 11 cero Road - Urmia University - Faculty of Sports Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
srowshani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Urmia University
Full name of responsible person
Mehrnaz Zolfeghari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective exercises
Street address
Km 11 cero Road - Urmia University - Faculty of Sports Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
zolfegharym@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Descriptive and inferential statistics will be used for statistical analysis. In order to check the normality of the data, the Shapiro-Wilk test will be used, and ANOVA test will be used for inferential statistics to compare variables between groups.
When the data will become available and for how long
Beginning of the access period after the defense of the thesis (since 1403)
To whom data/document is available
The data will be available to the public through theses and articles.
Under which criteria data/document could be used
The data will be available to the public through theses and articles.
From where data/document is obtainable
Mehrnaz Zolfaghari- zolfegharym@gmail.com Sajjad Roshani- srowshani@yahoo.com
What processes are involved for a request to access data/document
Analyzing the data and writing the fourth and fifth chapters for about a month and the defense time of Shahrivar 1403.
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