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IRCT20221120056547N1 IRCT 2023-03-01 Iran University of Medical Sciences Effect of Insole and Exercise in Adult Flatfoot Comparative Study of the Effect of Insole and Ankle-foot Muscles Strengthening on Plantar Pressure in Flexible Adult Flatfoot 2022-10-23 anticipated 40 Complete https://irct.ir/trial/66931 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple randomization Randomization Unit: Individual Randomization tool: Sealed envelope There is no concealment Each person participating in the study will be given 3 identical envelopes in which the name of the intended intervention will be written in each envelope. One envelope with muscle strengthening intervention, one envelope with foot orthosis intervention, one envelope with muscle strengthening intervention and foot orthosis. After choosing the envelope, the content of the envelope will be seen and the person will be considered in the group. In this study, people are aware of all types of therapeutic interventions and blinding does not occur. N/A Flexible flat foot. Intervention 1: First intervention group: Muscle strengthening. Each person is evaluated individually. The foot posture index is determined for each person and a score is given to each person. The type of daily shoes of the person and the level of his activity are questioned. Necessary strengthening exercises, which include walking on the toe and the outer edge of the foot, gathering a towel with the toes, and pulling a rope, were given to the people of this group, and the number of times and how to repeat them were taught under the supervision of a physiotherapist to be performed at home. In addition, the examiner checks how to do the exercises on a daily and weekly basis. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device. Intervention 2: Second intervention group: Foot orthosis. Foot posture index is determined for each person and each person is given a score. The type of daily shoes of the person and the level of his activity are questioned. A pair of functional foot orthosis is prepared for each subject. The orthoses are placed inside the appropriate shoes. It is explained to the person that he should avoid wearing inappropriate shoes while studying and it is better to use sports and medical shoes. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device. Intervention 3: Third intervention group: Foot orthosis and Muscle strengthening. Foot posture index is determined for each person and each person is given a score. The type of daily shoes of the person and the level of his activity are questioned. A pair of functional foot orthosis is prepared for each subject. The orthoses are placed inside the appropriate shoes. It is explained to the person that he should avoid wearing inappropriate shoes while studying and it is better to use sports and medical shoes. Necessary strengthening exercises, which include walking on the toe and the outer edge of the foot, gathering a towel with the toes, and pulling a rope, were given to the people of this group, and the number of times and how to repeat them were taught under the supervision of a physiotherapist to be performed at home. In addition, the examiner checks how to do the exercises on a daily and weekly basis. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device. 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 I will make a decision after sampling.
public Azadeh Shahini
Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) 1545913487 +98 17 3253 4240 shahini.a@iums.ac.ir Iran University of Medical Sciences scientific Hassan saeedi
Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) 1545913478 +98 21 2222 0947 Saeedi.H@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Flexible flat foot based on the Foot Posture Index score (6 and above) and the formation of an arch in the state of non-weight bearing Foot pain due to the symptoms of flexible flat foot Ability to follow the examiner's recommendations BMI of 19 to 25 Being 18 and older 18 years 30 years Both Using any types of foot orthoses in at least the last 3 months before the initiation of the intervention Malalignment of the lower limb and spine including genu-valgum and genu-varum, genu-recurvatum, leg Length discrepancy, hallux valgus and other deviations of the fingers and other abnormalities. History of injury, fracture and dislocation in the lower limb and a problem that affects the musculoskeletal system (cerebral palsy, polio, rickets myopathy, thyroid disease, rheumatoid arthritis, diabetes, stroke) Ulcer or skin disorder sensory or vascular disorder Q66.5 Congenital pes planus Treatment - Other Treatment - Other Treatment - Other First intervention group: Muscle strengthening. Each person is evaluated individually. The foot posture index is determined for each person and a score is given to each person. The type of daily shoes of the person and the level of his activity are questioned. Necessary strengthening exercises, which include walking on the toe and the outer edge of the foot, gathering a towel with the toes, and pulling a rope, were given to the people of this group, and the number of times and how to repeat them were taught under the supervision of a physiotherapist to be performed at home. In addition, the examiner checks how to do the exercises on a daily and weekly basis. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device. Second intervention group: Foot orthosis. Foot posture index is determined for each person and each person is given a score. The type of daily shoes of the person and the level of his activity are questioned. A pair of functional foot orthosis is prepared for each subject. The orthoses are placed inside the appropriate shoes. It is explained to the person that he should avoid wearing inappropriate shoes while studying and it is better to use sports and medical shoes. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device. Third intervention group: Foot orthosis and Muscle strengthening. Foot posture index is determined for each person and each person is given a score. The type of daily shoes of the person and the level of his activity are questioned. A pair of functional foot orthosis is prepared for each subject. The orthoses are placed inside the appropriate shoes. It is explained to the person that he should avoid wearing inappropriate shoes while studying and it is better to use sports and medical shoes. Necessary strengthening exercises, which include walking on the toe and the outer edge of the foot, gathering a towel with the toes, and pulling a rope, were given to the people of this group, and the number of times and how to repeat them were taught under the supervision of a physiotherapist to be performed at home. In addition, the examiner checks how to do the exercises on a daily and weekly basis. The plantar pressure of the foot is recorded with the RSscan device and the data is analyzed with the software. A person's walking speed is controlled by the sensors of the device. Plantar pressure. Timepoint: Measurement of plantar pressure at the beginning of the study (before the start of the intervention) and 60 days after using orthosis, muscle strengthening exercises and orthosis and muscle strengthening exercises simultaneously. Method of measurement: RSscan forceplate. Arch index. Timepoint: At the beginning of the study (before the start of the intervention) and after 60 days. Method of measurement: Calculation of the ratio of the area of the middle part of the foot to the whole foot by RSscan software. Iran University of Medical Sciences Approved 2022-10-19 Research Ethics Committees of Iran University of Medical Sciences Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)