comparing the effect of a 12-week gait retraining and short foot exercises on foot pronation in individuals with pronated foot: a randomised control trial
Can changing center of pressure and Foot progression angle impact rearfoot eversion and navicular drop in individuals with pronated foot
Design
Randomized control trial, Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Laboratory setting, randomized into 2 groups, only assessors will be blinded, not being aware of datas belong to which group
Participants/Inclusion and exclusion criteria
Inclusion: Healthy
Statically Pronated foot >4 degrees
Flat foot, static navicular drop>0.9 cm
No injuries in past 6 month
Active individuals, walking 3 times a week for at least 20 minutes
Exclusion:En Injured
Non-flat foot
Non-pronated foot
Sedentary life style
Any disease
Intervention groups
Gait retraining: lateralizing COP and toe-in walking
Short foot exercise
Main outcome variables
Peak rearfoot eversion, time to peak rearfoot eversion, rearfoot eversion at TD, rearfoot eversion excursion, medial longitudinal arch angle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230801058998N1
Registration date:2024-10-04, 1403/07/13
Registration timing:retrospective
Last update:2024-10-04, 1403/07/13
Update count:0
Registration date
2024-10-04, 1403/07/13
Registrant information
Name
Fateme Khorramroo
Name of organization / entity
University of tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2632 3962
Email address
negar_moj2004@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-25, 1403/07/04
Expected recruitment end date
2024-10-03, 1403/07/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effect of a 12-week gait retraining and short foot exercises on foot pronation in individuals with pronated foot: a randomised control trial
Public title
Effect of a 12-week gait retraining for flat foot
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy
Pronated foot >4 degrees
Flat foot
static navicular drop>0.9 cm
No injuries in past 6 month
Active individuals, walking 3 times a week for at least 20 minutes
Exclusion criteria:
Injured or any disease
Non-flat foot
Non-pronated foot
Sedentary life style
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
1
Kinematic data during gait
Randomization (investigator's opinion)
Randomized
Randomization description
After the baseline measurement, the participants will be divided randomly into the intervention group (INT) or control group (CON). A research assistant willgenerate the randomization schedule using a computer program and handed the results of allocation to the participants in a sealed envelope, ensuring that the researchers involved in outcome measurement and data analysis are unaware of the allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor and data and statistical analyzer will be blinded from knowing intervention groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of faculty of sport scienth and health, university of Tehran
Street address
North kargar street, faculty of sport scienth and health, university of Tehran
City
Tehran
Province
Tehran
Postal code
1664918948
Approval date
2024-09-25, 1403/07/04
Ethics committee reference number
IR.UT.SPORT.REC.1403.078
Health conditions studied
1
Description of health condition studied
Flat foot, pronated foot, pes planus
ICD-10 code
M21.4
ICD-10 code description
Flat foot [pes planus] (acquired)
Primary outcomes
1
Description
Peak rearfoot eversion ( ◦ )
Timepoint
First week and after 12 weeks
Method of measurement
Kinematic analysis using vican cameras
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After receiving the code of ethics, through an announcement, active sports women aged 18 to 40 with flat, flexible soles and arched feet are invited to this study. Tests for women will be conducted by a female test taker. By using the navicular drop test, it is ensured that these people have flat soles and arch of the back of the feet. Based on the entry criteria, 30 people will sign the consent form. The tools include a consent form, scale, meter, treadmill, Vikan 3D motion analysis system, marker. Data collection will be done in Mofaqian's laboratory using 6 Vicon cameras (Vicon MX-T40S) and 4 Vicon cameras (Vero (v2.2)). In order to measure the internal longitudinal arch of the sole of the foot, three markers will be attached to the inner part of the heel, the prominence of the navicular bone, and the head of the first metatarsal. The angle between these three markers in the middle distance of walking and running is considered as the angle of the internal longitudinal arch of the sole of the foot. In an announcement, active sports women aged 18 to 40 with flat flexible soles are invited to this study. By using the navicular drop test, it is ensured that these people have a flat sole and the arch angle of the back of the foot in a static state. Based on the entry criteria, 30 people will sign the consent form. After a five-minute warm-up period, the markers will be attached to the subjects' bodies. To measure the foot arch, three markers will be attached to the big toe bone, navicular bone and heel bone. To adjust the speed of walking and running to provide feedback and generalize it to all subjects, the speed of the treadmill for all subjects is set to 3 km/h for walking and 9 km/h for running. In the first session after warming up, all subjects They are asked to walk on the treadmill for two minutes, and the data of the last 20 seconds will be collected. The average angle of foot advancement and center of pressure of the sole of the foot in the first five steps is considered as the normal walking angle of the foot. The same process will be done while running. The foot advancement angle is the angle between the line connecting the markers on the heel bone and the second metatarsal head with the longitudinal axis of the treadmill. This line will be marked with a white stripe. In the second session, the subjects of the walking retraining group are asked to change the leg advancement angle within 5 degrees less than the normal leg angle (inward) through visual feedback and put the center of pressure on the outer edge of the leg. For this purpose, MATLAB code will be used to give visual feedback of the position of foot markers. Then the subject will be asked to try to place his foot in line with the light of the lasers while walking and running. Visual feedback and how to display the angle of leg progress is done using a video projector that displays the image of linear laser lines (treadmill tape) on a white screen placed in front of the subject. 12 weeks of training will be done.gait retraining sessions start with 15 minutes and reach to 40 minutes in the wekk 12.
Category
Rehabilitation
2
Description
Control group: After receiving the code of ethics, through an announcement, active sports women aged 18 to 40 with flat, flexible soles and arched feet are invited to this study. Tests for women will be conducted by a female test taker. By using the navicular drop test, it is ensured that these people have flat soles and arch of the back of the feet. Based on the entry criteria, 30 people will sign the consent form. The tools include a consent form, scale, meter, treadmill, Vikan 3D motion analysis system, marker. Data collection will be done in Mofaqian's laboratory using 6 Vicon cameras (Vicon MX-T40S) and 4 Vicon cameras (Vero (v2.2)). In order to measure the internal longitudinal arch of the sole of the foot, three markers will be attached to the inner part of the heel, the prominence of the navicular bone, and the head of the first metatarsal. The angle between these three markers in the middle distance of walking and running is considered as the angle of the internal longitudinal arch of the sole of the foot. In an announcement, active sports women aged 18 to 40 with flat flexible soles are invited to this study. By using the navicular drop test, it is ensured that these people have a flat sole and the arch angle of the back of the foot in a static state. Based on the entry criteria, 30 people will sign the consent form. Short foot exercises will be done for 12 weeks , 3 session each week including: Heel raise, Towel curls, Foot doming, Toe spread, Balance board, Foot relaxes. Starting from 1 set of 10 repeats and end in week 12 with 3 sets of 25 repetitions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Movafaghian laboratory
Full name of responsible person
Zahra Rafiei
Street address
Movafaghian laboratory, Khark street, Enghelab street
City
تهران
Province
Tehran
Postal code
1664918948
Phone
+98 21 6671 6100
Email
Gaitlab@sharif.edm
Web page address
http://www.mowafaghian.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Shahrzad Tahmasebi
Street address
17th Kargar
City
Tehran
Province
Tehran
Postal code
1664918948
Phone
+98 21 6111 8807
Email
shahzadtahmaseb@ut.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 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
University of Tehran
Full name of responsible person
Seyed Hamed Mousavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
17th north Kargar
City
Tehran
Province
Tehran
Postal code
1664918948
Phone
+98 21 6111 8807
Email
Musavihamed@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Fateme Khorramroo
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
17th kargar
City
Tehran
Province
Tehran
Postal code
1664918948
Phone
+98 21 2632 3962
Email
negar_moj2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Fateme Khorramroo
Position
Master
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
17th kargar
City
Tehran
Province
Tehran
Postal code
1664918948
Phone
+98 21 2632 3962
Email
negar_moj2004@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Final Outcome
When the data will become available and for how long
3 month after publication
To whom data/document is available
Everyone
Under which criteria data/document could be used
For research and rehabilitation
From where data/document is obtainable
Email
What processes are involved for a request to access data/document