UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of backpack and modified pack carriage in different weights on posture, kinematics and kinetics of gait in schoolchildren
Title of the study (Brief title)	The effects of backpack and modified pack
Region	Asia(except Japan)

Condition
Condition	we will assess the effects of tow types of packs in different weights on healthy male schoolchildren's gait to identify and introduce some best pack carriage condition
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In current research, comprehensive assessing of the postural, and gait's kinematics and kinetics variables by specific instrumented treadmill (Gaitway) will be done while carrying tow types of school pack in zero, 7.5, 10, 12.5 and 15 percent of body weight and in low and middle of back so that eventually help choosing good pack and carrying method.
Basic objectives2	Others
Basic objectives -Others	carrying backpacks have been suggested to be a risk factor for musculoskeletal pain and disorders, so prevention by safe methods is worthwhile
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	safest kind of pack (commercial backpack against modified wearable pack) The measurements would be completed in coming month
Key secondary outcomes	safest percent of packs' weight best position of pack on back (low or middle back)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Tow types of pack
Interventions/Control_2	Weights of each pack (0, 7.5, 10, 12.5, 15 percent of body weight)
Interventions/Control_3	position on back (low and middle of back only for 10% weight)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	8 years-old <=
Age-upper limit	12 years-old >=
Gender	Male
Key inclusion criteria	male 8 - 12 years old right hand and foot dominancy absence of a ban on carrying loads and packs
Key exclusion criteria	no pain and injury for recent 6 month no history of chronic disease no postural and gait abnormality no obesity (BMI over 30) no drug intake no history of surgery absence of severe vision and hearing problem no fever and caffeine before test
Target sample size	30

Research contact person
Name of lead principal investigator	Mohammad Hosein Alizade PhD
Organization	University of Tehran
Division name	Department of sports injuries and corrective exercises, faculty of physical education and sports sci
Address	15th st., North Karegar st., Tehran, Iran
TEL	009861118909
Email	mhalizadeh47@yahoo.com

Public contact
Name of contact person	Ali Akbar Jadidian
Organization	University of Tehran
Division name	Department of sports injuries and corrective exercises, faculty of physical education and sports sci
Address	15th st., North Karegar st., Tehran, Iran
TEL	00989354984388
Homepage URL
Email	akbar.ths@gmail.com

Sponsor
Institute	University of Tehran
Institute
Department

Funding Source
Organization	University of Tehran
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Iran

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	University of Tehran, Faculty of physical education and sports sciences

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 15 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2018 Year 07 Month 21 Day
Date of closure to data entry	2018 Year 08 Month 07 Day
Date trial data considered complete	2018 Year 08 Month 15 Day
Date analysis concluded	2018 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 24 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037762