Comparison the effect of activation sequences of intrinsic and extrinsic foot muscles on selected foot muscles cross section area and Normalized Truncated Navicular Height in boys afflicted by flat foot
Comparison the effect of activation sequences of intrinsic and extrinsic foot muscles on selected foot muscles cross section area and Normalized Truncated Navicular Height in boys afflicted by flat foot
Design
Two groups of intrinsic and extrinsic exercises with the blinded evaluator grouped randomly based on a random numbers table. For each group minimum of 8 individuals in each group were considered.
Settings and conduct
The test protocol will be performed in Amin hospital of Isfahan city under the supervision of a rehabilitation specialist. The tests including the assessment of the cross-section area (CSA) of the selective foot muscels and naicular drop. The CSA will be tested by alpinon ecube 9 and nacvicular drop by a ruler. The evaluator will be blinded to the participants' group.
Participants/Inclusion and exclusion criteria
Age (10-13), sex (boys), flexible flat foot, haven't injury or surgery in the lower extremity, haven't anatomical LLD, haven't structural dorsiflexion limitation, don't use other modalities.
Intervention groups
There are two groups: intrinsic and extrinsic exercises. The intrinsic exercises group will perform short foot exercises for 6 weeks and the extrinsic group will perform superficial foot muscles strengthening for 6 weeks. Then the groups will change their exercises.
Main outcome variables
The cross-section area of selected foot muscles; navicular drop.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210818052223N1
Registration date:2021-09-08, 1400/06/17
Registration timing:registered_while_recruiting
Last update:2021-09-08, 1400/06/17
Update count:0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
jafar ketabchi
Name of organization / entity
The university of tehran
Country
Iran (Islamic Republic of)
Phone
+98 31 3458 3685
Email address
j.ketabchi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of activation sequences of intrinsic and extrinsic foot muscles on selected foot muscles cross section area and Normalized Truncated Navicular Height in boys afflicted by flat foot
Public title
Comparison the activation sequences of deep and superficial foot muscle on CSA and navicular drop in flat feet children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
flexible flat foot
haven't structural deformity in pelvic or foot
don't use insole support during the study period
10-13 age
boys
don't use medicine or have a special surgery
Exclusion criteria:
Structural flat foot
Have a structural deformity in the pelvic or foot
No willingness to enter the study
use other modalities during the study
Age
From 10 years old to 13 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
8
Randomization (investigator's opinion)
Randomized
Randomization description
After recruiting the participants in the research, their names are chronologically written in a list. After that, each participant is allocated a number. Two groups of intrinsic and extrinsic exercises are assigned to the participants based on a random table of numbers. In this way, a number is randomly selected first, and then by the movement to one direction, the next numbers are selected until half of the participants are selected for the intrinsic group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the evaluator ( rehabilitation specialist) will not know whom she is analysing. For blind the evaluator, the groups and their exercises will remain unknown. Also the data analyst will not have access to this information. For this, the information related to the groups would be given the data analyst in a way that will not reveal the group members.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University
Street address
16th Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۹۳۵۸۴۰
Approval date
2020-09-20, 1399/06/30
Ethics committee reference number
IR.UT.SPORT.REC.1399.008
Health conditions studied
1
Description of health condition studied
flexible flat foot
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
cross section area of selective foot muscels
Timepoint
before, 6 weeks after and 12 weeks after
Method of measurement
ultrasond alpinon ecube 9
2
Description
navicular drop
Timepoint
before, 6 weeks and 12 weeks after
Method of measurement
ruller
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intrinsic foot muscle strengthening. the participants will recieved short foot exercises at minimum three days a week, one hour during the day in six weeks. they need only a theraband.
Category
Rehabilitation
2
Description
Intervention group: extrinsic foot muscels strengthening. the exercises will include strengthening of gastrocinemius, soleus and tibilais anterior and posterior muscles. the participants will performe exercises at minimum three days a week, one hour during the day in six weeks. they need only a theraband.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Corrective Exercises Centers Of Schools
Full name of responsible person
Jafar Ketabchi
Street address
Etehad Ave, Kave Ave, Isfahan, Ale Yasin School
City
Isfahan
Province
Isfehan
Postal code
8193843155
Phone
+98 31 3459 3603
Email
info@gama.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University Of Tehran
Full name of responsible person
Foad Seidi
Street address
16th Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۹۳۵۸۴۰
Phone
+98 21 8835 1730
Email
publicrel@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University Of Tehran
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
The University Of Tehran
Full name of responsible person
Jafar Ketabchi
Position
PHD Candidate
Latest degree
Master
Other areas of specialty/work
Others
Street address
No 37, Gole Roz Ave, Barazande Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8193843155
Phone
+98 31 3458 3685
Email
J.ketabchi@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University Of Tehran
Full name of responsible person
Jafar Ketabchi
Position
PHD Candidate
Latest degree
Master
Other areas of specialty/work
Others
Street address
No 37, Gole Roz Ave, Barazande Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8193843155
Phone
+98 31 3458 3685
Email
J.ketabchi@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University Of Tehran
Full name of responsible person
Jafar Ketabchi
Position
PHD Candidate
Latest degree
Master
Other areas of specialty/work
Others
Street address
No 37, Gole Roz Ave, Barazande Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8193843155
Phone
+98 31 3458 3685
Email
J.ketabchi@ut.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
the private information of the patricipants will not published, but the assessment information will.
When the data will become available and for how long
will be accessible from 2021
To whom data/document is available
the data will be accessible as paper and phd thesis for interested individuals.
Under which criteria data/document could be used
the interested individuals that approximate the university to access the thesis or individuals that have access to the publisher.
From where data/document is obtainable
university of tehran, sport science faculty.
What processes are involved for a request to access data/document
after showing student card, the student can have access to thesis.