The effect of arch support insole in shoes and sandals on medial arch collapse in school_aged children with flexible flat foot during standing and walking
The effect of arch support insole in shoes and sandals on medial arch collapse in school_aged children with flexible flat foot during standing and walking
Design
A cross-over type clinical study that each participant will receive all the interventions of the study in one session and randomly. In this study, the data will be analyzed both statically (while standing) and dynamically (Mid stance and Heel off). To randomize the order of the tests (static or dynamic), the method of drawing lots by the patient (taking the envelope in the package from inside a basket) is used.
Settings and conduct
In this research, 40 children are selected non-randomly from those who refer to the technical orthopedic centers of Tehran and Karaj by easy and accessible sampling method
Participants/Inclusion and exclusion criteria
Inclusion criteria included: participants aged 7_11 with flexible flat foot and Foot Posture Index FPI ⩾ 6 .
exclusion criteria included: any previous history of ligaments laxity based on Beighton test , Achill tendon contracture based on Silfverskiold test, neuromuscular problems, limb length discrepancies of 1/5 cm or greater , orthopedic disease, Functional abnormalities which can
impair gait pattern, foot deformities such as hallux valgus, hallux rigidus, hammer toe, claw toe.
Intervention groups
A pair of shoes and sandals and arch support insole will be provided for each subject which is apt with their foot length
Main outcome variables
first toe dorsiflexion angle /MLA angle/Arch height index(AHI)/ ankle dorsiflexion angle/rear foot angle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059520N1
Registration date:2023-11-21, 1402/08/30
Registration timing:retrospective
Last update:2023-11-21, 1402/08/30
Update count:0
Registration date
2023-11-21, 1402/08/30
Registrant information
Name
Sajedeh Haghighi Poodeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3226 7600
Email address
s.haghighi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of arch support insole in shoes and sandals on medial arch collapse in school_aged children with flexible flat foot during standing and walking
Public title
The effect of arch support insole in shoes and sandals on medial arch collapse in school_aged children with flexible flat foot during standing and walking
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
flexible flat foot
Exclusion criteria:
Age
From 7 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib Ave.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-11-19, 1402/08/28
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.136
Health conditions studied
1
Description of health condition studied
flexible flat foot
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
arch support insole/sandal/shoe/age/gender/foot length/BMI
Timepoint
Measuring and collecting information before the start of tests
Method of measurement
Collecting patient information through personal information questionnaire, measuring body mass index through meters and scales
Secondary outcomes
1
Description
first toe dorsiflexion angle/MLA angle/Arch height index(AHI)/ankle dorsiflexion angle/rearfoot angle
Timepoint
The duration of each test is 2 minutes, with 5 repetitions and 2-minute breaks, the data obtained from the Mid stance and Heel off moments will be collected.
Method of measurement
Kinematic data will be collected using a Samsung, India (galaxy A71) mobile phone camera, with a frequency of 240 Hz and a resolution of 1920 x 1080 and 5 flat reflective markers with a diameter of 6 mm,
Intervention groups
1
Description
Intervention group: 1- Walking with bare feet 2- Walking with shoes 3- Walking with shoes with insoles 4- Walking with sandals 5- Walking with sandals with insoles.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Navide-salamat center
Full name of responsible person
Sajedeh Haghighi Poodeh
Street address
No.96, Marjan Ave., North Taleghani Blvd., Karaj Town
City
Karaj
Province
Alborz
Postal code
3153633544
Phone
+98 26 3226 7600
Email
sajedeh.haghighi1365@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi Demneh
Street address
Hezarjarib Ave.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi Demneh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Hezarjarib Ave.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Fax
Email
sadeghi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi Demneh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Hezarjarib Ave.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Fax
Email
sadeghi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi Demneh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Hezarjarib Ave.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Fax
Email
sadeghi@rehab.mui.ac.ir
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
The findings are sent to scientific journals for publication.
When the data will become available and for how long
The findings are sent to scientific journals for publication.
To whom data/document is available
The findings are sent to scientific journals for publication.
Under which criteria data/document could be used
The findings are sent to scientific journals for publication.
From where data/document is obtainable
The findings are sent to scientific journals for publication.
What processes are involved for a request to access data/document
The findings are sent to scientific journals for publication.
Comments
The findings are sent to scientific journals for publication.