UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033130
Receipt No. R000037762
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
Date of disclosure of the study information 2018/09/01
Last modified on 2018/06/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 06 Month 24 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.