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The effects of backpack and modified pack carriage in different weights on posture, kinematics and kinetics of gait in schoolchildren

Protocol summary

Study aim
The aim was investigating and comparison of posture, kinematic and kinetic of during walking and carrying backpack and modified pack (with three bags that distribute the load equally in front and back of trunk) in 7.5, 10, 12.5, and 15 percent of body weight, in two heights of placement only in the 10% load, among 8 – 11 years old schoolboys.
Design
Within group comparison of eleven times randomized (repeated) measuring for each participant, Single blind
Settings and conduct
Location:Tehran city, motor control laboratory of electrical and computer faculty, university of Tehran. Method: Each participant in one day, walked on Gaitway treadmill, while carrying backpack and modified pack with four different weights. At the end of each trial, then, the data recording was done. All randomized measurements (11 trials) were saved with a code then later calculations and analysis would be done. After calculations, trials would be arranged according to the primary list. Thus researcher and measurer didn't know how the measurements arrangement are, and each file of data is related to which trial, till the end of process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.The age ranged from 8 to 11 years; 2.Male gender; 3.The subject and his parent's consent; 4.Right hand and foot dominancy. Exclusion criteria: Any condition affecting on gait and carrying packs by participants.
Intervention groups
Tow types of packs; Four different load for each one of packs; Tow position of each pack only in 10% of body weight load .
Main outcome variables
Postural parameters including craniovertebral angle, trunk forward lean, hip and knee angle; Vertical ground reaction force parameters including first and second peaks, loading rate, support phase peak; Kinematical parameters of gait including stride length, step width, double support time, cadence, swing phase time,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180607039995N1
Registration date: 2020-04-28, 1399/02/09
Registration timing: retrospective

Last update: 2020-04-28, 1399/02/09
Update count: 0
Registration date
2020-04-28, 1399/02/09
Registrant information
Name
Ali Akbar Jadidian
Name of organization / entity
Payamenoor university
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 3644
Email address
jadidiths@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-27, 1397/03/06
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
2018-06-09, 1397/03/19
Actual recruitment end date
2018-08-05, 1397/05/14
Trial completion date
2018-08-05, 1397/05/14
Scientific title
The effects of backpack and modified pack carriage in different weights on posture, kinematics and kinetics of gait in schoolchildren
Public title
Effect of the carriage of tow types of pack on schoolchildren
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The age ranged from 8 to 11 Male gender The subject and his parent's consent Right hand and foot dominancy
Exclusion criteria:
pain and injury within 6 months leading to measurement obesity with a BMI of over 30 history of chronic diseases postural and walking abnormalities such as flat foot drug intake fever within 72 hours leading up to measurement severe vision and hearing impairment history of surgery
Age
From 8 years old to 11 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 11
Each participant will be avaluated for 11 times. First is walking without backpack and load as control. 4 times is caring conventional backpack in different weights (7/5, 10, 12/5, 15 percent of body weight). 4 times is caring modified backpack in mentioned same weights. The 2 remained is caring every pack with 10% weight at mid-back position.
Actual sample size reached: 28
More than 1 sample in each individual
Actual sample size in each individual: 11
Each participant was avaluated for 11 times. First was walking without backpack and load as control. 4 times was caring conventional backpack in different weights (7/5, 10, 12/5, 15 percent of body weight). 4 times was caring modified backpack in mentioned same weights. The 2 remained was caring every pack with 10% weight at mid-back position.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Prior to measurement, each participant's data sheet was coded without specification, and all measurement interventions were randomly assigned to each participant in the sheet and each intervention was numbered. Each number is issued by the technician of the device, respectively. Therefore, the researcher and evaluator and data analyzer until the end of the analysis process in SPSS is unaware from the nature of the data and their relationship to the repetition.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of physical education and sports science faculty, university of tehran
Street address
physical education and sports science faculty of university of tehran, AmirAbad, North Kargar
City
Tehran
Province
Tehran
Postal code
1439813117
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.UT.SPORT.REC.1397.002

Health conditions studied

1

Description of health condition studied
Backpack, modified pack, gait, posture, kinetics, kinematics, pack position
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
postural parameters
Timepoint
one time, while applying independent variable
Method of measurement
Panasonic camera, NV-GS75

2

Description
Vertical ground reaction force
Timepoint
one time, while applying independent variable
Method of measurement
H/P/Cosmos Gaitway

3

Description
Spatiotemporal parameters of gait
Timepoint
one time, while applying independent variable
Method of measurement
H/P/Cosmos Gaitway

Secondary outcomes

empty

Intervention groups

1

Description
Control group: walking no load on level surface
Category
Prevention

2

Description
Intervention group: walking while carrying a backpack with 7.5% of body weight load.
Category
Prevention

3

Description
Intervention group2: walking while carrying a backpack with 10% of body weight load.
Category
Prevention

4

Description
Intervention group3: walking while carrying a backpack with 12.5% of body weight load.
Category
Prevention

5

Description
Intervention group4: walking while carrying a backpack with 15% of body weight load.
Category
Prevention

6

Description
Intervention group5: walking while carrying a modified pack with 7.5% of body weight load.
Category
Prevention

7

Description
Intervention group6: walking while carrying a modified pack with 10% of body weight load.
Category
Prevention

8

Description
Intervention group7: walking while carrying a modified pack with 12.5% of body weight load.
Category
Prevention

9

Description
Intervention group8: walking while carrying a modified pack with 15% of body weight load.
Category
Prevention

10

Description
Intervention group9: walking while carrying a backpack with 10% of body weight load, on thoracic position
Category
Prevention

11

Description
Intervention group10: walking while carrying a modified pack with 10% of body weight load, on thoracic position
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Motor control laboratory, electrical and computer engineering faculty of university of Tehran
Full name of responsible person
Dr Fariba Bahramiِ
Street address
15th street, North Kargar street
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۷۱۳۱
Phone
+98 21 6111 4924
Email
fbahrami@ut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physical Education and Sports Science, University of Tehran
Full name of responsible person
Dr Mohammad Hosein Alizade
Street address
Physical education and sports science faculty, 15th street, north kargar street
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 6111 8909
Email
mhalizadeh47@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Education and Sports Science, University of Tehran
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
university of tehran
Full name of responsible person
Ali Akbar Jadidian
Position
Lecturer, Payame-noor
Latest degree
Ph.D.
Other areas of specialty/work
corrective exercises
Street address
15th street, north kargar
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 6111 8916
Email
jadidiths@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Dr. Mohammad Hosein Alizade
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
15th street, north kargar street
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 6111 8909
Email
mhalizadeh47@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Ali Akbar Jadidian
Position
Lecturer, Payame-noor university
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
15th street, north kargar street
City
Tehran
Province
Tehran
Postal code
1439813117
Phone
+98 21 6111 8916
Email
jadidiths@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish IPD in this study.
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 mean and standard deviation of demographic information, and all data will publish as thesis and original article. There is no need to publish lore than these.
When the data will become available and for how long
After submitting the thesis, 2019
To whom data/document is available
It will be free after publishing the thesis and article.
Under which criteria data/document could be used
After publish, it will be free with referencing.
From where data/document is obtainable
University of Tehran to achieve and reading full text of the thesis, and after publishing the articles, by searching in related scientific databases.
What processes are involved for a request to access data/document
There is no other kind of request to achieve more information.
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