Purpose of this study: Designing And Fabrication An Ergonomic Insole To Correct Foot Posture In Pregnant Women.
Study design: Randomized to intervention and control groups.
Methodology:
A) The study population:
- The Inclusion criteria: Pregnant women who are in the age range 18-32 and are in week 20 of pregnancy.
-The exclusion criteria: Those with congenital musculoskeletal disorders, surgery on the leg, and any kinds of living and working conditions that have an impact on the foot and posture.
- Sample size: 50 Pregnant women
B- Intervention or interventions Of studied: Providing an ergonomic insoles for women
C- Time of intervention: 20 Weeks of pregnancy until 36 weeks (3 months)
D- Primary outcome or consequences of the study: Supporting foot arch. Improving foot posture and reducing back pain and Expected to reduce foot pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021121044N1
Registration date:2015-05-10, 1394/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Shaghayegh Koohi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 331 2741
Email address
kouhi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, .Shiraz University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and fabrication an ergonomic insole to correct foot posture in pregnant women.
Public title
Designing and fabrication an ergonomic insole to correct foot posture in pregnant women.
Purpose
Prevention
Inclusion/Exclusion criteria
The Inclusion criteria: pregnant women who are in the age range of 18-32 and are in the 20th week of pregnancy.
The exclusion criteria: those with congenital musculoskeletal disorders, surgery on the leg, and any condition that have an impact on the foot and posture.
Age
From 18 years old to 32 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
delete
Secondary trial Id
delete
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of shiraz university of medical sciences
Street address
Health faculty, Fath-Al-Mobin alley, Zahra Ave, Shiraz
City
Shiraz
Postal code
Approval date
2014-04-09, 1393/01/20
Ethics committee reference number
CT-9373-7293
Health conditions studied
1
Description of health condition studied
Foot posture in pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
effect on longitudinal arch of foot
Timepoint
3 month
Method of measurement
Foot posture index, Fiess line
2
Description
Supporting longitudinal arch of foot
Timepoint
3 month
Method of measurement
Foot posture index, Fiess line
3
Description
Effect on rotation of heels during pregnancy
Timepoint
3 month
Method of measurement
Foot posture index, Fiess line
Secondary outcomes
1
Description
Effect on backache during pregnancy
Timepoint
3 month
Method of measurement
Foot posture index, Fiess line
2
Description
Effect on back pain after pregnancy
Timepoint
3 month
Method of measurement
Foot posture index, Fiess line
3
Description
Effect on kneeache after pregnancy
Timepoint
3 month
Method of measurement
Foot posture index, Fiess line
4
Description
Effect on kneeache during pregnancy
Timepoint
3 month
Method of measurement
Foot posture index, Fiess line
Intervention groups
1
Description
Intervention group: Assessment of Foot posture in pregnant women at 20 weeks of pregnancy and then giving them medical insoles made of leather and foam designed for pregnant women and Finally, Assessment feet of women after 3 months.
Category
Other
2
Description
Control: No action, Evaluation of foot in pregnant women in 20 weeks of pregnancy and then assess the feet of women within 3 months.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez clinic
Full name of responsible person
Dr. Samsami
Street address
Hafez Hospital, Chamran Blvd, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, .Shiraz University of Medical Sciences
Full name of responsible person
Dr.Basir Hashemi, Manager of Research and assessment of investigations
Street address
Vice chancellor for research؛ The seventh floor, Central Building of shiraz university of medical sciences, next to the Red Cross, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, .Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Health
Full name of responsible person
Shaghayegh Koohi
Position
Student, Msd Ergonomic
Other areas of specialty/work
Street address
Health faculty, Fath-Al-Mobin alley, Zahra Ave, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
sh.kouhi.b@gmail.com؛ schealth@sums.ac.ir
Web page address
schealth.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mohsen Razeghi
Position
Associate Professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences, Chamran Blvd, Abiverdi1 St, Shiraz
City
Shiraz
Postal code
33669-71947
Phone
+98 71 3626 5108
Fax
+98 71 3627 2495
Email
razeghm@sums.ac.ir؛ rehabdep@sums.ac.ir
Web page address
rehab.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Health
Full name of responsible person
Shaghayegh Koohi
Position
Student, Msd Ergonomic
Other areas of specialty/work
Street address
Health faculty, Fath-Al-Mobin alley, Zahra Ave, Shiraz
City
Shiraz
Postal code
Phone
Fax
Email
sh.kouhi.b@gmail.com; kouhi@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)