Determining and comparing ergonomic features of three types of medical insoles in long standing tasks
Design
This interventional study was performed without a control group, with a single, double-blind group with 20 male participants.
Settings and conduct
This study is done in a shoe manufacturing company. the method of doing the work is as follows: the selected medical insoles are provided to the subjects and each subject for three weeks (one type of insole per week) and the number of working days per week and in all The length of the shift will use medical insoles. At the beginning and end of each working day, The amount of pain and discomfort in different parts of the legs and lower limbs is questioned using the visual analogue scale. . To measure the pressure of the sole of the foot, this study uses FSR sensors, that will be glued to two soles. Also, at the beginning and end of each work shift, leg volume changes in three areas will be measured using a Gulick meter.
Participants/Inclusion and exclusion criteria
Gender of male with age range between 30 to 45 years
People whose job requires standing for a long time
Absence of musculoskeletal disorders and problems
Intervention groups
Selected insoles in this study include anti-stress silicone insoles, sensitive foot silicone insoles and visco elastic polyurethane insoles. The duration of the test for each subject is three weeks (one type of insole per week) and the number of working days per week and throughout the shift. The order of using the insoles for all people will be completely random and using the insole numbering method and then choosing randomly (lottery)
Main outcome variables
Introducing the best type of insole to reduce musculoskeletal disorders and disorders caused by prolonged standing
Provide information on the effectiveness of shoe insole interventions in standing tasks for the industrial and service sectors
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180902040923N2
Registration date:2021-09-17, 1400/06/26
Registration timing:prospective
Last update:2021-09-17, 1400/06/26
Update count:0
Registration date
2021-09-17, 1400/06/26
Registrant information
Name
Mohamad Sadegh Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4839
Email address
ghasemi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review and comparison of ergonomic features of three types of insoles in prolonged standing tasks: a field study in a shoe manufacturing factory
Public title
Review and comparison of ergonomic features of three types of insoles in prolonged standing tasks: a field study in a shoe manufacturing factory
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gender of male subjects with age range between 40 to 50 years
Height and weight of 50th percentile
Having 2 years of standing work experience
People whose job requires standing for a long time (one shift). (In this study, a cutting job was selected for the study.)
Placement in the standard range of spinal curvatures (thoracic vertebral kyphosis, lumbar lordosis, and cervical lordosis)
Exclusion criteria:
Absence of musculoskeletal disorders and problems
Absence of neurological defects
Lack of autoimmune diseases such as rheumatoid arthritis and ....
Absence of cardiovascular disorders
No history of doing heavy sports activities
Absence of congenital disorders in the foot area such as flat feet, excessive arch of the foot, wrist and knee deviations
No history of accidents and injuries in the foot area during the past year
Age
From 30 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
3
Each participant uses all three insole samples during the study
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiner (or in other words, the researcher) and the participants will not have a role in choosing the type of insole, but when placing the insole in the subject's shoes, the examiner will notice the type of insole, but this will not affect the work process. Because all output variables are based on objective observations and opinions of the subject and the researcher will only be in charge of process management.
Placebo
Not used
Assignment
Single
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-08-03, 1400/05/12
Ethics committee reference number
IR.IUMS.REC.1400.034
Health conditions studied
1
Description of health condition studied
Musculoskeletal Disorders
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain and discomfort in the lower extremities after using three types of insoles
Timepoint
The beginning and the end of each day
Method of measurement
Borg Pain Scale and Scale
2
Description
The amount of volumetric changes in the leg after using three types of insoles
Timepoint
The beginning and the end of each day
Method of measurement
Using the Gulick meter
3
Description
The amount of foot pressure distribution after using three types of insoles
Timepoint
the end of each day
Method of measurement
FSR sensors
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: 20 men participated in the study. The duration of the test for each subject is three weeks (one type of insole per week) and the number of working days per week and throughout the shift. The order of using the insoles for all people will be completely random and using the insole numbering method and then choosing randomly (lottery).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
shima shoes factory
Full name of responsible person
mohammad sadegh ghasemi
Street address
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower,Tehran
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4839
Email
ghasemi.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Ghasemi
Street address
Iran University of Medical Sciences- Hemmat Highway next to Milad Tower -Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4839
Email
ghasemi.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Sadeq Ghasemi
Position
PhD in Biomechanics
Latest degree
Ph.D.
Other areas of specialty/work
Ergonomics
Street address
Ergonomic Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Fax
Email
ghasemi.m@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
MohammadSadegh Ghasemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Ergonomics
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
ghasemi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohamas Sadegh Ghasemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Fax
Email
ghasemi.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available