Compare the effect of prefabricated soft medical insole and custom-molded thermoplastic insole on plantar pressure distribution in athletes with Flexible flat Foot
Compare the effect of prefabricated soft medical insole and custom-molded thermoplastic insole on plantar pressure distribution in athletes with Flexible flat Foot
Design
Interventional study, without control and blinding, randomized, 18 subjects
Settings and conduct
This research is conducted at the Institute of sport sciences and Iran rehabilitation school.After making custom-molded thermoplastic insole in Iran rehabilitation school,order shoes and prefabricated soft medical insole, the tests are performed at the institute of sport on Pedar device.Tests include walking without insoles,walking with prefabricated soft medical insole and walking with custom-molded thermoplastic insole.
Each of these tests is performed three times on a 9-meter path at a normal speed of 50 Hz.
Participants/Inclusion and exclusion criteria
Flexible flat foot with specialist doctor diagnosis or foot posture index؛
The age range 18 to 25؛
Be an amateur athlete؛
Absence of length difference in the lower extremities؛
Lack of severe injury to the lower extremities recently؛
Absence of skeletal malformation؛
No history of spine or bone surgery in the lower extremities؛
No neurological or rheumatic problems that affect walking.
Intervention groups
intervention group 1:walking with prefabricated soft medical insole and study with Pedar device.
intervention group 2: walking with custom-molded thermoplastic insole and study with Pedar device.
intervention group 3:walking without insole and study with Pedar device.
Main outcome variables
peak pressure,mean pressure ,force and cross area In eight parts of foot.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140219016643N7
Registration date:2020-02-28, 1398/12/09
Registration timing:retrospective
Last update:2020-02-28, 1398/12/09
Update count:0
Registration date
2020-02-28, 1398/12/09
Registrant information
Name
Behshid Farahmand
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
farahmand.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-18, 1398/10/28
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
2020-01-18, 1398/10/28
Actual recruitment end date
2020-02-01, 1398/11/12
Trial completion date
2020-02-01, 1398/11/12
Scientific title
Compare the effect of prefabricated soft medical insole and custom-molded thermoplastic insole on plantar pressure distribution in athletes with Flexible flat Foot
Public title
Compare the effect of prefabricated soft medical insole and custom-molded thermoplastic insole on plantar pressure distribution in athletes with Flexible flat Foot
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Flexible flat foot with specialist doctor diagnosis or foot posture index.
The age rang 18 to 25.
Amateur athlete.
Absence of length difference in the lower extremities.
Lack of severe injury to the lower extremities recently.
Absence of skeletal malformation.
No history of spine or bone surgery in the lower extremities.
No neurological or rheumatic problems that affect walking.
Exclusion criteria:
Individual's dissatisfaction to enter the study.
Wound or injury during the study.
Age
From 18 days old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
Actual sample size reached:
18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
Hemat Highway next to Milad Tower,Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.IUMS.REC.1398.1035
Health conditions studied
1
Description of health condition studied
Flexible flat foot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
Peak pressure
Timepoint
Instantly during tests, measurements are made.
Method of measurement
Pedar X (version10.3) / Made by German novel company
2
Description
Mean pressure
Timepoint
Instantly during tests, measurements are made.
Method of measurement
Pedar X (version10.3) / Made by German novel company
3
Description
Force
Timepoint
Instantly during tests, measurements are made.
Method of measurement
Pedar X (version10.3) / Made by German novel company
4
Description
Contact area
Timepoint
Instantly during tests, measurements are made.
Method of measurement
Pedar X (version10.3) / Made by German novel company
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:walking with prefabricated soft medical insole and study with Pedar device.
Category
Other
2
Description
Intervention group 2: Walking with costum-molded thermopelastic insole and study with Pedar device.
Category
Treatment - Devices
3
Description
Intervention group 3: Walking without medical insole and study with Pedar device.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences of Iran University
Full name of responsible person
Seyede Gelare Razavi Khorasani
Street address
Mother Square, Shahnazari Street, Madadkaran Srteet, Faculty of Rehabilitation Sciences of iran university
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
gelarerazavii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr kazem Malakoti
Street address
Hemat Highway,next to Milad Tower,Iran University of Medical Science
City
Tehran
Province
Tehran
Postal code
149614535
Phone
+98 21 8670 2503
Email
research@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
Behshid Farahmand
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Mother Squre,Shahnazari Street,Madadkaran street,Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
farahmand.b@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Mother Squre,Shahnazari Street,Madadkaran street,Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
farahmand.b@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Mother Squre,Shahnazari Street,Madadkaran street,Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
farahmand.b@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
Title and more details about the data/document
All data can be shared after unidentifiable people.
When the data will become available and for how long
Starting one year after article publication.
To whom data/document is available
Information is available to all researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.
From where data/document is obtainable
Connect to Dr Behshid Farahmand by email: Farahmandb1@yahoo.com
What processes are involved for a request to access data/document
If information is used in scientific and therapeutic activities, information is provided as soon as possible.