Comparison the effects of foot insole with skive technique and insole with medial wedge on postural control parameters in flexible flat foot population
The aim of this study is to compare the effects of foot insole with skive technique and insole with medial wedge on postural control parameters in flexible flat foot population
Design
This clinical trial will conduct on only one group include 20 flat foot patients for determining the effects of foot insole with skive technique and insole with medial wedge on postural control parameters in flexible flat foot population
Settings and conduct
This study will be conducted in Hamadan university of medical science. Insoles will be fabricated according to skive method. After that, postural control (center of pressure) parameters will be measured with kistler force plate and analyses with qualysis soft ware.
Participants/Inclusion and exclusion criteria
People with having informed consent about participating in research, +6 foot posture index or more, having flexible according to the tiptoe test data will be included in this study.
People with having rigid flat feet, having history of neurological disorders, such as Cerebral Palsy (CP), Polio and spina bifida or having lower limb length discrepancy history of surgery in the lower limb will exclude in this study.
Intervention groups
Insole fabricated with the skive technique and insole with medial wedge, In one session of 60 minute.
Main outcome variables
center of pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190919044818N4
Registration date:2023-08-14, 1402/05/23
Registration timing:prospective
Last update:2023-08-14, 1402/05/23
Update count:0
Registration date
2023-08-14, 1402/05/23
Registrant information
Name
Ensieh Pourhosaingholi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 3255
Email address
ensiehpmd@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of foot insole with skive technique and insole with medial wedge on postural control parameters in flexible flat foot population
Public title
Efficacy of insole on flexible flat foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent about participating in research
having flexible flat foot according to the tiptoe test data
+6 grade foot posture index or more
Exclusion criteria:
having rigid flat feet
having history of neurological disorders, such as Cerebral Palsy (CP), Polio and spina bifida
having lower limb length discrepancy
history of surgery in the lower limb
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commete of Hamadan univesity of medical science
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
Before intervention and immidiatly after intervention
Method of measurement
using force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: using insole with skive technique and insole with medial arch in one session 60 minute with camera and force plate
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan university of medical science
Full name of responsible person
Ensieh Pourhoseingholi
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 918 339 9369
Email
ensiehpmd@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 918 339 9369
Email
ensiehpmd@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Pourhoseingholi
Position
Assisstant professore
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 918 339 9369
Email
ensiehpmd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Pourhoseingholi
Position
Assisstant professore
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 918 339 9369
Email
ensiehpmd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh pourhoseingholi
Position
Assisstant professore
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Hamadan University of Medical Sciences Shahid Fahmideh Aven.., Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 918 339 9369
Email
ensiehpmd@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Efficacy of insole on flat foot walking
When the data will become available and for how long
After publication of article in 1403
To whom data/document is available
researchers
Under which criteria data/document could be used
For research in health care system
From where data/document is obtainable
By e-mail to ensieh Pourhoseingholi
ensiehpmd@yahoo.com
What processes are involved for a request to access data/document