Evaluation the effect of insole with longitudinal arch support on foot and ankle kinematics in children with flexible flat foot who have undergone subtalar arthroeresis
Evaluation the effect of insole with longitudinal arch support on foot and ankle kinematics in children with flexible flat foot who have undergone subtalar arthroeresis
Design
Clinical trial without control group, Single blind, Sample size of 10 patients, Our intervention in this study is insole with medial longitudinal arch support.
Settings and conduct
this test is performed in the research center of Isfahan faculty of sciences and rehabilitation and our intervention in the test is insole with medial longitudinal arch support that its material is soft foam. in this test, biomechanics of the foot and ankle are measured before and after the use of medical insole.
Participants/Inclusion and exclusion criteria
Entry condition:
1. age between 7 to 18
2. has flexible flat foot
3. undergone Arteroeresis surgery
4. a minimum of 6 months and maximum of 3 years have passed since the surgery
condition of non-entry
1. flat foot due to neuromuscular, neurological diseases
2. history of lower limb trauma and any foot surgery
3. Existence of other deformities in the lower limbs
Intervention groups
the Sampling method is based on the available sampling method and among those referred to the orthopedic clinic of kashani hospital. the sample size is 10 children with flexible flat feet after artroeresis surgery.
the intervention group includes 10 patient with flexible flat foot who undergone Surgery and receive medical insole interventions.
there is no control group in this study.
Main outcome variables
kinematics of the joints of the feet and ankles of children while walking.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211030052916N1
Registration date:2021-11-28, 1400/09/07
Registration timing:registered_while_recruiting
Last update:2021-11-28, 1400/09/07
Update count:0
Registration date
2021-11-28, 1400/09/07
Registrant information
Name
Amirhossein Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3646 6919
Email address
zareamirhossein75@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2021-12-01, 1400/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of insole with longitudinal arch support on foot and ankle kinematics in children with flexible flat foot who have undergone subtalar arthroeresis
Public title
Evaluation the effect of insole on the feet of operated Children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A child between the ages of 7 to 18 with flexible flat foot who has undergone subtalar arthroeresis Surgery
minimum of 6 months and maximum of 3 years from the surgery
Exclusion criteria:
Flat foot caused by neurological, neuromuscular, dystrophic and hyperlaxis diseases
history of lower limb trauma and any foot surgery
Angular and rotational deformities of the lower limbs during walking
Existence of any other pathology such as tarsal coalition, vertical talus, Skew foot, Accessory navicular bone
Age
From 7 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Ethics committee of Isfahan university of medical sciences
Percentage of kinematic effect of insole on children undergoing Artroeresis surgery
Timepoint
Biomechanical measurement of the foot before and after using the insole
Method of measurement
Visual 3D Software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For each patient, a pair of medical insoles made of soft foam, which the patient steps on and walks with during the test. For testing each patient, a 2.5 hour back session was provided and these medical insole were of perfabricated type and were provided by technical orthopedic clinics.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal center of the faculty of rehabilitation sciences
Full name of responsible person
Doctor Ebrahim Sadeghi Demneh
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
muigaitlab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Shaghayegh haghjoy javanmard
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 8007
Email
muigaitlab@gmail.com
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
Doctor Saeed Forghany
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Technical Orthopedics
Street address
Masjed lomban Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+44 7775 987245
Email
saeed_forghany@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Saeed Forghany
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Technical Orthopedics
Street address
Masjed lomban Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+44 7775 987245
Email
saeed_forghany@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amirhossein Zare
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Technical Orthopaedic
Street address
Farzanegan Street, in front of Super Eram, Number plate 442
City
Shiraz
Province
Fars
Postal code
7194783899
Phone
+98 71 3646 6919
Fax
Email
zareamirhossein75@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
Some of the tested data related to patients foot and ankle kinematics can be extracted. Patient personal information is not shared.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
in addition to academic researchers in the field of flexible flat foot and a variety of treatment methods, Statistical analyzer for activity with Shapirolic and SPSS software and t-test study should be aware of the information and data. the main condition for data delivery is not making the data availabale to the public.
From where data/document is obtainable
Principal executor and supervisor of research project
What processes are involved for a request to access data/document
By emailing the project manager or instructor
Dr Saeed Forghany - saeed_forghany@yahoo.co.uk