Investigation of the performance variables of the musculoskeletal system extracted from biomechanical data in gait and balance in women with flat feet before and after 6 weeks of exercise therapy and Comparison with people with normal arch
Design
The participants are people with flat feet and people with normal feet. People with flat feet are divided into two intervention and control groups. The clinical trial has a double blind and randomized with a sample size of 40. There is no trial phase.
Settings and conduct
There are two groups of people with normal and flat feet. The evaluation of balance, gait and arch height variables for both groups of people with flat feet in the intervention and treatment groups will be done in two sessions with an interval of 6 weeks, at the Movement Disorders Research Center of Tarbiat Modares University. The intervention group will do the exercises during 6 weeks, while the control group will not do any exercises. The person responsible for data collection and the person analyzing the data are not aware of the allocation of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with bilateral flexible flat feet؛ Normal Body Mass Index؛ Ages 18-45
Exclusion criteria: History of any lasting orthopedic or neurological damage in the lower limbs and spine; leg length discrepancy more than 1.5 cm; Body mass index more than 25; Obvious deformities in lower limb
pregnancy
pain during tests
Intervention groups
The intervention group will perform 6 weeks of foot exercises with elastic band and the variables will be measured before and after 6 weeks. also, the control group will not do any exercises during 6 weeks and the variables will be measured before and after that.
Main outcome variables
Biomechanical variables related to the performance of the musculoskeletal system during gait and balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049511N7
Registration date:2024-05-21, 1403/03/01
Registration timing:prospective
Last update:2024-05-21, 1403/03/01
Update count:0
Registration date
2024-05-21, 1403/03/01
Registrant information
Name
Sahar Boozari
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 5053
Email address
s.boozari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 6 Weeks of Combined Traning for Foot Intrinsic Muscles and Tibialis Posterior on Walking and Balance in Women with Flexible Flat Feet
Public title
The Effect of Exercise Therapy on Gait and Balance in Women with Flat Feet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non Athlete Women Suffering From Bilateral Flexible Flat Feet( Arch Height Ratio Less Than 0.221)
Normal Body Mass Index (18.5-25)
Age 18-35 Years Old
Exclusion criteria:
History Of Any Lasting Orthopedic Or Neurological Injury In The Lower Limbs And Spine
The Difference In The Actual Length Of The Lower Body Be More Than 1.5 Centimeters
Significant Congenital Malformation In The Lower Limbs
Pregnancy
The History Of Corrective Exercises For Flat Feet In The Last 6 Months
Pain During Tests
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be done by block randomization method so that people will be randomly placed in two intervention or control groups. This work will be done by someone outside the research team. The random method is done through blocks of four, from each block, 2 people are assigned to each group. The order of people in each block will be randomized by Excel software. Sealed envelopes are used to insert the random chain. Code 1 is considered for the intervention group and code 0 for the control group. People from number 1 to 40 take turns to pick an envelope from the package and then they are placed in one of the groups based on the chosen code.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Person Recording the Lab's Data and the Person Analyzing the Data are not aware of the study group allocation.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.MODARES.REC.1402.255
Health conditions studied
1
Description of health condition studied
Flexible Flat Foot
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
Biomechanical variables related to balance and gait
Timepoint
Before and after 6 weeks after intervention
Method of measurement
Force plate device
2
Description
Arch height ratio
Timepoint
Before and after 6 weeks after intervention
Method of measurement
Arch height ratio device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The intervention consists of 6 weeks of exercises for women with flexible flat feet. In the first session, after measuring the height of the medial arch of the foot and getting familiar with how to perform the tests, the subject will perform the jump tests and then, the variables will be recorded. Then the person will be taught to do both short foot exercises and foot adduction exercises with an elastic band. The individuals should do these exercises for 6 weeks, with a frequency of 5 times a week and 3 sets of 10 each time. After the end of 6 weeks, the final evaluation session will be done in the laboratory like the first session.
Category
Treatment - Other
2
Description
Control group: This group will not receive any exercise and participants will be evaluated before and after 6 weeks. In the first session, after measuring the height of the medial arch of the foot and getting familiar with how to perform the tests, the subject will perform the jump tests and then, the variables will be recorded. After the end of 6 weeks, the final evaluation session will be done in the laboratory like the first session.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Treatment Center for Movement Disorders of Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Email
s.boozari@modares.ac.ir
Web page address
http://ptmodares.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tarbiat Modares
Full name of responsible person
Amir Abdollahzadeh
Street address
Tarbiat Modares University, Jalal Al Ahmad, Pol Nasr, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Email
Res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tarbiat Modares
Proportion provided by this source
100
Public or private sector
Private
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 Tarbiat Modares
Full name of responsible person
Sedighe Akbarzadeh
Position
Master's Student in Physiotherapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Email
19Akbarzadeh99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Sahar Boozari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran, Tehran, Jalal Al ahmad Highway, Nasr Bridge, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Email
s.boozari@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Sahar Boozari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Iran, Tehran, Jalal Al ahmad Highway, Nasr Bridge, Tarbiat Modares University
City
tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Email
s.boozari@modares.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
Information about the main outcome can be shared after people are not identified.
When the data will become available and for how long
After the results are published, the access phase started six months later
To whom data/document is available
Researchers in academic and research organizations will also have access to the data.
Under which criteria data/document could be used
To do scientific research
From where data/document is obtainable
to do scientific research, Sahar Boozari, Jalal Al Ahmad Highway, Tarbiat Modares University, s.boozari@modares.ac.ir, 00982182885053
What processes are involved for a request to access data/document
Send the project plan, and if approved, it will be sent following a complete evaluation of the persons and organizations involved in the project.