UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033130 |
|---|---|
| Receipt number | R000037762 |
| Scientific Title | 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 | 2018/12/27 03:30:27 |
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Basic information
Public title
The effects of backpack and modified pack carriage in different weights on posture, kinematics and kinetics of gait in schoolchildren
Acronym
The effects of backpack and modified pack
Scientific Title
The effects of backpack and modified pack carriage in different weights on posture, kinematics and kinetics of gait in schoolchildren
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Mohammad Hosein Alizade PhD |
Organization
University of Tehran
Division name
Department of sports injuries and corrective exercises, faculty of physical education and sports sci
Zip code
Address
15th st., North Karegar st., Tehran, Iran
TEL
009861118909
mhalizadeh47@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ali Akbar Jadidian |
Organization
University of Tehran
Division name
Department of sports injuries and corrective exercises, faculty of physical education and sports sci
Zip code
Address
15th st., North Karegar st., Tehran, Iran
TEL
00989354984388
Homepage URL
akbar.ths@gmail.com
Sponsor or person
Institute
University of Tehran
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 15 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037762
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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