Protocol summary

Study aim
The aim of this study is to investigate the effect of different pedagogy methods (linear and nonlinear) on lower limb kinematics in gait motor skill in children 3-5 years old.
Design
This clinical trial with control group will be performed on 36 children.
Settings and conduct
This research will be done in the Faculty of Physical Education of Kharazmi University. For this purpose, 36 children aged 3-5 years will be randomly divided into three groups (two exercise groups and one control group). Pre-test will be performed. Then the exercises will be performed for 6 weeks. Then the post-test will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 3-5 years with no history of lower limb injury and underlying disease will be randomly assigned to the intervention and control groups. Exclusion criteria: Children with physical and mental disorders will not participate in the study.
Intervention groups
Intervention group 1: Linear pedagogy. Intervention group 2: Nonlinear pedagogy. Control group 1: control. In intervention groups 1 and 2, children will receive a walking educational program for six weeks. In the control group, children will not participate in the educational program and will only participate in pre-test and post-test. - Training period: six weeks, - Number of training sessions per week: two sessions per week, - Duration of each training session: 30 minutes (5 minutes of warm-up, 20 minutes of the main body of the class which includes walking training, 5 minutes of cool-down will be performed in each session).
Main outcome variables
lower limb kinematics while walking, stride length.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130109012078N5
Registration date: 2021-05-14, 1400/02/24
Registration timing: registered_while_recruiting

Last update: 2021-05-14, 1400/02/24
Update count: 0
Registration date
2021-05-14, 1400/02/24
Registrant information
Name
Maryam Ghorbani
Name of organization / entity
Azad
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 2382
Email address
maryamm_ghorbanii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-04, 1400/02/14
Expected recruitment end date
2021-07-05, 1400/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different types of pedagogy (linear and nonlinear) on lower limb kinematics in walking motor skills in children: a preliminary study of injury prevention
Public title
Investigating the effect of pedagogy on gait pattern
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
children aged 3-5 years. without a history of injury and underlying disease. Ability to walk.
Exclusion criteria:
Children with physical and mental disorders.
Age
From 3 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
By lottery, individuals are divided into intervention and control groups. The children's names are written on a piece of paper and placed in a box. The names are then randomly removed from the box. Then the first person in the linear group, the second person in the nonlinear group and the third person in the control group are placed and continue, respectively.
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
Kharazmi University
Street address
Faculty of Physical Education & Sports Sciences of Kharazmi University, Mirdamad Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1571914911
Approval date
2020-12-06, 1399/09/16
Ethics committee reference number
IR.KHU.REC.1399.031

Health conditions studied

1

Description of health condition studied
gait
ICD-10 code
Y93.0
ICD-10 code description
Activities involving walking and running

Primary outcomes

1

Description
Kinematics of gait (angles of the lower extremity joints) in the sagittal plane
Timepoint
Measurements will be performed before and after the training intervention.
Method of measurement
Using GoPro Black 7 camera, children's gait will be recorded before and after the intervention. Using Kinovea software, the measurements of the joint angles of the lower extremity at the moment of heel contact with the ground and the moment of the big toe off from the ground will be calculated.

2

Description
stride length
Timepoint
Measurements will be performed before and after the training intervention.
Method of measurement
Using GoPro Black 7 camera, children's gait will be recorded before and after the intervention. Stride length will be calculated by using Kinovea software.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: linear pedagogy. In linear pedagogy, the child will first be presented with the correct gait pattern (verbally and with a visual pattern). The child will then be asked to follow the specified path and at the same time the child will be given feedback. - Training period: six weeks, - Number of training sessions per week: two sessions per week, - Duration of each training session: 30 minutes (5 minutes of warm-up, 20 minutes of the main body of the class which includes walking training, 5 minutes of cool-down will be performed in each session).
Category
Prevention

2

Description
Intervention group 2: nonlinear pedagogy. In non-linear, each session will be designed according to the intended goals. The child will then be allowed to walk in the environment. - Training period: six weeks, - Number of training sessions per week: two sessions per week, - Duration of each training session: 30 minutes (5 minutes of warm-up, 20 minutes of the main body of the class which includes walking training, 5 minutes of cool-down will be performed in each session).
Category
Prevention

3

Description
Control group: control. The control group will not receive training for six weeks. They will only take the pre-test and post-test.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Lena School and Kindergarten
Full name of responsible person
Maryam Ghorbani
Street address
No. 14., at the beginning of Roshnaei St, North Kaveh Boulevard, Sadr Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1318835835
Phone
+98 21 2220 0989
Email
maryamm_ghorbanii@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
kharazmi University
Full name of responsible person
Dr. Hamid Rajabi
Street address
Faculty of Physical Education & Sports Sciences of Kharazmi University, Mirdamad Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 8832 9220
Email
hrajabi@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
kharazmi 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
kharazmi University
Full name of responsible person
maryam ghorbani
Position
student
Latest degree
Master
Other areas of specialty/work
Motor behavior
Street address
No. 27., Deilman Str, Nofalah Str, Azadi St., Tehran.
City
Tehran
Province
Tehran
Postal code
1313886873
Phone
+98 21 6656 2382
Email
maryamm_ghorbanii@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
kharazmi University
Full name of responsible person
Rasoul Yaali
Position
University Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Faculty of Physical Education & Sports Sciences Kharazmi University of Tehran, Mirdamad Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 8832 9220
Email
r.yaali@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
kharazmi University
Full name of responsible person
Maryam Ghorbani
Position
student
Latest degree
Master
Other areas of specialty/work
motor behavior
Street address
No. 27., Deilman St, Nofalah St, Azadi St, Tehran.
City
Tehran
Province
Tehran
Postal code
1313886873
Phone
+98 21 6656 2382
Email
maryamm_ghorbanii@yahoo.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
Data on walking kinematics, stride length, and static balance before and after the intervention will provided to the audience.
When the data will become available and for how long
September 2021
To whom data/document is available
Students and university professors
Under which criteria data/document could be used
This trial will be published in the form of a master's thesis.
From where data/document is obtainable
One should refer to the library of Kharazmi University.
What processes are involved for a request to access data/document
Students will go to the library and receive a thesis file from the librarian.
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