The aim of this study is to determine whether textured insoles can improve balance in people with flexible flat foot or not? This can improve our strategies to decrease damages from the disorder. Participants selected by a convenient sampling from students of the Iran University of Medical Sciences and were included as intervention group. The study population is men with bilateral flexible flat foot. Inclusion criterion: having a bilateral flexible flat foot.
Exclusion criteria: history of brain injury, visual impairment; using any orthoses 6 months before the test; professional sports; inability to perform the tests because of problems with balance and .... . The sample size in this study have been considered 20 subjects. Interventions include: the use of shoes only, shoes and common medical insoles & shoes with textured insoles. The time taken to perform each test is 30 seconds.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081116643N2
Registration date:2016-11-29, 1395/09/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-29, 1395/09/09
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
Iran University of Medical Sciences
Expected recruitment start date
2016-04-29, 1395/02/10
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate effect of textured insole on dynamic balance in flexible flatfooted persons
Public title
Effect of textured insole on balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having a bilateral flexible flat foot; age in range 20 to 26 years old.
Exclusion criteria were as follows: a history of any orthopedic or neurological injury; a history of damage to the vestibular system or brain damage; visual impairment; use of drugs affecting the balance; use of orthosis within 6 months before the test; doing professional sports; inability to perform the tests due to balance problems and unwillingness to cooperate until the end of the test for any reason.
Age
From 20 years old to 26 years old
Gender
Male
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences Ethics Committe
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
IR.IUMS. REC.1394.9211502203
Health conditions studied
1
Description of health condition studied
Flat foot
ICD-10 code
Q66.5
ICD-10 code description
Congenital pes planus
Primary outcomes
1
Description
dynamic balance
Timepoint
at the same time in one session
Method of measurement
using a force plate device
Secondary outcomes
1
Description
displacement and mean excursion of CoP in main directions including antero-posterior and medio-lateral and ancillary directions between them
Timepoint
at the same time in one session
Method of measurement
using a force plate device
Intervention groups
1
Description
1- using same shoes for all participants and then standing on the force plate
2- using typical conventional medical insole in the aforementioned shoes and standing on the force plate
3- using textured insole in the aforementioned shoes and standing on the force plate
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Iran university of medical sciences
Full name of responsible person
Behshid Farahmand
Street address
Rehabilitation Faculty, Iran University of Medical Sciences, Shahnazari St., Mirdamad Aven.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research & technology of Iran university of medical sciences
Full name of responsible person
Mrs. Kordlou
Street address
Tehran-hemmat highway-between shahid chamran and sheikh fazlolah- Iran university of medical sciences- vice chancellor for research & technology
City
Tehran
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 & technology of 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
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Master of science/lecturer
Other areas of specialty/work
Street address
Rehabilitation Faculty, Iran University of Medical Sciences, Shahnazari St., Mirdamad Aven.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
farahmandb1@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aliakbar Nazari
Position
Master of science in orthotics & prosthetics
Other areas of specialty/work
Street address
Rehabilitation Faculty, Iran University of Medical Sciences, Shahnazari St., Mirdamad Aven.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
aliakbarnazari8869@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aliakbar Nazari
Position
Master of science
Other areas of specialty/work
Street address
Rehabilitation Faculty, Iran University of Medical Sciences, Shahnazari St., Mirdamad Aven.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
aliakbarnazari8869@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)