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IRCT20230801058998N1 IRCT 2024-10-04 University of Tehran Effect of a 12-week gait retraining for flat foot 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 2024-09-25 anticipated 30 Complete https://irct.ir/trial/79172 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 description: Outcome assessor and data and statistical analyzer will be blinded from knowing intervention groups. 3 Flat foot, pronated foot, pes planus. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Seyed Hamed Mousavi
17th north Kargar
Tehran Iran (Islamic Republic of) 1664918948 +98 21 6111 8807 Musavihamed@ut.ac.ir University of Tehran scientific Fateme Khorramroo
17th kargar
Tehran Iran (Islamic Republic of) 1664918948 +98 21 2632 3962 negar_moj2004@yahoo.com University of Tehran Iran (Islamic Republic of) 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 18 years 40 years Female Injured or any disease Non-flat foot Non-pronated foot Sedentary life style M21.4 Flat foot [pes planus] (acquired) Rehabilitation Rehabilitation 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. 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. Peak rearfoot eversion ( ◦ ). Timepoint: First week and after 12 weeks. Method of measurement: Kinematic analysis using vican cameras. University of Tehran Approved 2024-09-25 Ethics committee of faculty of sport scienth and health, university of Tehran North kargar street, faculty of sport scienth and health, university of Tehran Tehran Tehran Iran (Islamic Republic of)