The Immediate effect of medical shoe on the gait kinetics in children with Flexible Flatfoot
Design
24 Patients will be included in the study non-randomly
Settings and conduct
This study will be conducted on children with flexible flat feet. The subjects in this study will be selected from the patients referred to the Orthosis and Prosthetics department, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences. Before the main test, first, the steps and objectives of the test are explained to the eligible people (parents of the child), then each of the parents of the children participating in the study completes the consent form. The information needed for people to enter the study will be collected through face-to-face questions, FPI questionnaires and clinical test.
levels:
• Randomly, using a lottery, we determine the order of testing three shoe modes.
•5 minutes of walking before the test for more adaptation
• Using the force plate Kistler model , we ask the child to walk on the force plate once with normal shoes, once with thick-soled medical shoes and another time with thin-soled medical shoes at the same speed.
• COP and parameters of vertical forces of ground reaction, anterior posterior and internal external forces of ground reaction during walking are measured and examined in three test conditions.
Participants/Inclusion and exclusion criteria
inclusion criteria
sever and moderate flexible flatfoot based on FPI-6
Bilateral flexible flatfoot
age 6-10
without fracture and surgery
without systemic disease like CP or Rickets
without Genuvalgum and Genuvarum
exclusion criteria:
dissatisfaction for continuing
uncomfortable to continue the test
Intervention groups
the effect of three types of medical shoes with hard soles, medical shoes with soft soles and normal shoes on the ground reaction force
Main outcome variables
Ground reaction force
Center of pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140219016643N10
Registration date:2023-11-26, 1402/09/05
Registration timing:retrospective
Last update:2023-11-26, 1402/09/05
Update count:0
Registration date
2023-11-26, 1402/09/05
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
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Immediate effect of medical shoe on the gait kinetics in children with Flexible Flatfoot
Public title
The Immediate effect of medical shoe on the gait kinetics in children with Flexible Flatfoot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
moderate and sever flexible flatfoot based onFPi-6
Bilateral flexible flat foot
age 6-10
non fracture and surgery
without systemic disease like CP or rickets
without genuvalgum or genuvarum
Exclusion criteria:
The person's lack of consent to continue cooperation
The feeling of discomfort or fatigue of the person in such a way that she is not able to continue cooperation.
Age
From 6 years old to 10 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
N/A
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 Iran University of Medical Sciences
Street address
Shahrake Quds - between South Flamak and Zarafshan - Simai Iran - Ministry of Health headquarters
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2022-08-10, 1401/05/19
Ethics committee reference number
IR.IUMS.REC.1401.414
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
Earth reaction force: According to Newton's third law, the earth reaction force is the force that the earth exerts on an object in contact with it. When a person is just standing, this force corresponds to the person's weight. When the body is moving, the ground reaction force increases due to acceleration forces. The ground reaction force has three components: fz, fx, and fy. • Vertical ground reaction forces Fz • vGRF is the largest component of the ground reaction force along the path. It is walking that results in forces greater than one body weight at each step. The vGRF curve consists of two peaks: the first peak (in the weight bearing phase) and the second peak (push off phase). This force is to support the body and prevent the body from falling during movement. The vertical ground reaction force represents the magnitude and pattern of vertical mechanical loading on the foot and is commonly used in the diagnosis of abnormal gait. The type of movement, the slope of the ground, the speed of movement, body mass, mass distribution, the material of the shoe, the material of the movement surface, and the mechanics of the foot are effective in the amount of this force. Ground reaction forces in the anterior-posterior direction F The forces of this component of the ground reaction are smaller than It is vertical and is about 25% of body weight. At the beginning of the stationary phase, this force causes the leading foot to brake or slip, and its value is negative in the first 50%, indicating that the person is pushed backwards, and at the end of the stationary phase, it is towards the front, and its value is positive. be And it makes progress forward.
Timepoint
immediate
Method of measurement
Using Kistler's Force plate device, we ask the child to walk on the force plate once with normal shoes, once with thick sole medical shoes and another time with thin sole medical shoes. We measure the parameters of vertical forces of ground reaction, anterior, posterior and internal external forces of ground reaction which are recorded in the form of a diagram while walking in three test situations.
2
Description
• The amount of displacement of the center of pressure: • Theoretical definition: the value of displacement of the result point of the earth's reaction force • Applied definition: the number shown by the computer dynamic state device in centimeters related to the X and Y axes.
Timepoint
immediate
Method of measurement
Using the Kistler plate force plate device, we ask the child to walk on the force plate once with normal shoes, once with thick sole medical shoes and another time with thin sole medical shoes. We record the number shown by the computerized body dynamics device in centimeters related to the X and Y axes.
Secondary outcomes
empty
Intervention groups
1
Description
• First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes( with rigid sole, soft sole and regular shoe) for 5 minutes to adapt to it, and then enters the measurement phase. Using the Kistler force plate device, we ask the child to walk on the force plate once in a position with normal shoes. COP and the parameters of vertical ground reaction forces, anterior posterior and internal external forces of ground reaction during walking are measured and checked.
Category
Treatment - Devices
2
Description
Intervention group: • First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes for 5 minutes to adapt to it, and then enters the measurement step. Using the Kistler force plate device, we ask the child To walk on the force plate with thick sole medical shoes. • COP and parameters of vertical ground reaction forces, anterior posterior and internal external forces of ground reaction during walking are measured and checked.
Category
Treatment - Devices
3
Description
Intervention group: • First, using the foot posture index questionnaire (FPI-6), we perform a complete examination of the child's foot and determine its index. Before performing each step, the child walks with each of the shoes for 5 minutes to adapt to it, and then enters the measurement phase. Using the Kistler force plate device, we ask the child to walk on the force plane in the condition of thin-soled medical shoes. • COP and the parameters of the vertical ground reaction forces, anterior, posterior and internal external forces of the ground reaction during walking are measured and checked.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran university of medical scienes - department of othotics and prosthtics
Full name of responsible person
Behshid Farahmand
Street address
Madar Square, Shah Nazari St., Faculty of Rehabilitation Sciences ,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Fax
+98 21 2222 0946
Email
farahmandb1@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Shah nazari st- Mother SQ- Rehabilitation sciences faculty Tehran Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Fax
+98 21 2222 0946
Email
farahmandb1@yahoo.com
Web page address
http://www.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
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Shahnazari st- Mother Sq- Rehabilitation science faculty Tehran Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
farahmandb1@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Shahnazari st- Mother Sq- Rehabilitation science faculty Tehran Iran
City
Tehran
Province
Tehran
Postal code
11545913487
Phone
+98 21 2222 0947
Email
farahmandb1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistant Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Shahnazari st- Mother Sq- Rehabilitation science faculty Tehran Iran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
farahmandb1@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The average data will be reported in the paper extracted from the research
When the data will become available and for how long
The start of the access period after the publication of the article
To whom data/document is available
public
Under which criteria data/document could be used
The results of this research
From where data/document is obtainable
contact with : farahmandb1@yahoo.com
What processes are involved for a request to access data/document
Depending on the conditions of the journal, the results are printed