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The effect of backpack carriage in different weights and gradients on kinetics and kinematics of schoolchildren’s gait

Protocol summary

Study aim
Evaluating the effects of backpack carriage in different weights (10 and 15% of BW) and gradients (+15% and -15%) on the kinetics and kinematics of schoolchildren’s gait compared to the control level walking
Design
Within group comparison of eleven times randomized (repeated) measuring for each participant with applying independent variables, Single blind
Settings and conduct
Location:Tehran city, sport science laboratory of payame-noor university, Tehran branch. Method: Each participant in one day, walks on Gaitway treadmill, while carrying backpack in tow different weights. The surface of treadmill will randomly change to get to the target slopes. At the end of each trial, then, the data recording will be done. All randomized measurements (11 trials) will save with a code then later calculations and analysis will be done. After calculations and at the time of data entering into the SPSS, trials will be arranged according to the primary list. Thus researcher and measurer don'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. male gender (boys living in Tehran), 2. ages between 10-12 years, 3. informed consent, 4.right dominant hand and foot; Exclusion criteria: 1. current pain, disease and taking drug, 2. any history of injuries for recent 6 month, 3. any history of surgery, 4. obvious postural abnormality, 5. flat foot, 6. vision and hearing impairment
Intervention groups
Intervention groups: Backpack in two weights, gradient in four levels Control group: Level surface
Main outcome variables
Vertical ground reaction force parameters including the peaks and loading rate, push off rate, time to peak, etc.; kinematical parameters of gait including stride length, step width, double support time, cadence, swing phase time, etc.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180614040101N1
Registration date: 2018-10-31, 1397/08/09
Registration timing: retrospective

Last update: 2018-10-31, 1397/08/09
Update count: 0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Fateme Ahmadi Godini
Name of organization / entity
Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8001
Email address
std_ahmadi.ths@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-08, 1397/05/17
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of backpack carriage in different weights and gradients on kinetics and kinematics of schoolchildren’s gait
Public title
Evaluating the effect of backpack carriage on schoolchildren’s gait in different gradients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
male gender (boys living in Tehran) ages between 10-12 years informed consent right dominant hand and foot
Exclusion criteria:
current pain, disease and taking drug any history of injuries for recent 6 month any history of surgery obvious postural abnormality, flat foot vision and hearing impairment
Age
From 10 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 19
More than 1 sample in each individual
Number of samples in each individual: 11
1. no load, no slope 2. 10% load, no slope 3. 15% load, no slope 4. 10% load, +10% slope 5. 10% load, -10% slope 6.10% load, +15% slope 7.10% load, -15% slope 8. 15% load, +10% slope 9.15% load, -10% slope 10.15% load, +15% slope 11. 15% load, -15% slope
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Each participant is given a code, and all repetitions of measurement are run randomly, but the number is issued by the technician of the device, respectively. Therefore, the researcher and evaluator 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 Tarbiat Modares University of Medical Sciences
Street address
Jalal AleAhmad, Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.MODARES.REC.1397.045

Health conditions studied

1

Description of health condition studied
Backpack, gait, kinetics, kinematics, slope, schoolchildren
ICD-10 code
ICD-10 code description

Primary outcomes

1

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

2

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 group1: walking no load on level surface
Category
Prevention

2

Description
Control group2: walking while carrying a backpack with 10% of body weight load on the level surface.
Category
Prevention

3

Description
Control group3: walking while carrying a backpack with 15% of body weight load on the level surface.
Category
Prevention

4

Description
Intervention group1: walking while carrying a backpack with 10% of body weight load on 10% sloped surface.
Category
Prevention

5

Description
Intervention group2: walking while carrying a backpack with 15% of body weight load on 10% sloped surface.
Category
Prevention

6

Description
Intervention group3: walking while carrying a backpack with 10% of body weight load on 10% negative sloped surface.
Category
Prevention

7

Description
Intervention group4: walking while carrying a backpack with 15% of body weight load on 10% negative sloped surface.
Category
Prevention

8

Description
Intervention group5: walking while carrying a backpack with 10% of body weight load on 15% sloped surface.
Category
Prevention

9

Description
Intervention group6: walking while carrying a backpack with 15% of body weight load on 15% sloped surface
Category
Prevention

10

Description
Intervention group7: walking while carrying a backpack with 10% of body weight load on 15% negative sloped surface.
Category
Prevention

11

Description
Intervention group8: walking while carrying a backpack with 15% of body weight load on 15% negative sloped surface.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Payam-e noor university
Full name of responsible person
Sport science lab technician
Street address
Nejatollahi
City
Tehran
Province
Tehran
Postal code
1598686613
Phone
+98 21 8891 0055
Email
mahdieh.koosha2014@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi university
Full name of responsible person
Ali Abbasi
Street address
Mirdamad, Hesari
City
Tehran
Province
Tehran
Postal code
4398-15875
Phone
+98 21 2222 8001
Email
abbasi@khu.ac.ir
Web page address
https://pess.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
Fateme Ahmadi Godini
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Sport biomechanics
Street address
Mirdamad, Hesari
City
Tehran
Province
Tehran
Postal code
4398-15875
Phone
+98 22228001
Email
std_ahmadi.ths@khu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Mehdi Khaleghi Tazeji
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport biomechanics
Street address
Mirdamad, Hesari
City
Tehran
Province
Tehran
Postal code
4398-15875
Phone
+98 21 2222 8001
Email
khaleghi@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Fateme Ahmadi Godini
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Sport biomechanics
Street address
Mirdamad, Hesari
City
Tehran
Province
Tehran
Postal code
4398-15875
Phone
+98 21 2222 8001
Email
std_ahmadi.ths@khu.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 defense of the thesis and publishing its article; December may be.
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
Kharazmi university to achieve and reading full text of the thesis, and after publishing the article, 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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