The purpose of this study was to determine the effect of a poron insole on ground reaction force and centre of pressure in subjects with flexible flat foot and comparison with common insole. Twenty six subjects (7 Male and 19female) with flexible flat foot participated in this clinical trial. 13 subjects received poron insole and 13 subjects received common insole. Vertical ground reaction force and displacement of centre of pressure were assessed with force plate in the first session and next two weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905144441N4
Registration date:2010-08-28, 1389/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-28, 1389/06/06
Registrant information
Name
Hassan Jafari
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912139131382
Email address
hjafari@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2008-10-28, 1387/08/07
Expected recruitment end date
2009-06-19, 1388/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of New Insole on Ground Reaction Force and Centre of Pressure in Subjects with Flexible Flat Foot and Comparison with Common Insole
Public title
Effect of Insole on Ground Reaction Force and Centre of Pressure in Subjects with Flexible Flat Foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 40, not using any insole before test, presence of flexible flat foot, No lower limb surgery history, No ligamentus instability, No musculoskeletal disorder, No Leg length discrepancy more than 1cm
Exclusion criteria: Not using insole at least 40 hours for two weeks, loss to follow-up
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Rehabilitation Faculty, Iran University of Medical Sciences
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd.
City
Tehran
Postal code
Approval date
2008-07-19, 1387/04/29
Ethics committee reference number
151
Health conditions studied
1
Description of health condition studied
Flexible Flat Foot
ICD-10 code
Q66.5
ICD-10 code description
Congenital pes planus
Primary outcomes
1
Description
Ground Reaction Force
Timepoint
Baseline, 2 weeks after medial longitudinal arch support insole prescription
Method of measurement
Force plate
2
Description
Centre of Pressure
Timepoint
Baseline, 2 weeks after medial longitudinal arch support insole prescription
Method of measurement
Force plate
Secondary outcomes
1
Description
Stability with displacement of centre of pressure
Timepoint
Baseline and two weeks after prescription of medial longitudinal arch support
Method of measurement
Standard Deviation of centre of pressure
Intervention groups
1
Description
Prescription of the common insole
Category
Other
2
Description
Prescription of the common insole with poron layer
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Resaech, Iran University of Medical Sciences
Full name of responsible person
Dr Maziar Moradi Lakeh
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Resaech, Iran 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
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Ghasemi
Position
Assistant Professor, PhD
Other areas of specialty/work
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2222 7124 ext. 202
Fax
Email
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical University, Faculty of Rehabilitation Sciences
Full name of responsible person
Fatemeh Khanmohammad
Position
Master of science in orthotics and prosthetics
Other areas of specialty/work
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2222 7124 ext. 202
Fax
Email
Khanmohammad_61@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical University, Faculty of Rehabilitation Sciences
Full name of responsible person
Fatemeh Khanmohammad
Position
Master of science in orthotics and prosthetics
Other areas of specialty/work
Street address
Faculty of Rehabilitation Sciences, Shahnazari St, Madar Ave, Mirdamad Blvd
City
Tehran
Postal code
Phone
+98 21 2222 7124 ext. 202
Fax
Email
khanmohammad_61@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)