]>
IRCT20210419051014N1 IRCT 2021-06-18 University of social welfare and rehabilitation sciences The effect of gait plate insole and medial-wedge insole for children with in-toeing gait Comparison of the effect of gait plate insole and medial-wedge insole on balance and angle of gait of the in-toeing child 2021-02-14 anticipated 30 Complete https://irct.ir/trial/55724 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used. This method is used to balance the number of samples assigned to each of the study groups. In this study, considering that we have two groups, blocks with size of 4 are used. The randomization tool is used is random allocation software that is able to generate random sequences by block randomization method. Group assignment is hidden in dark, sealed envelopes that are numbered consecutively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of that participant is revealed, Blinding description: Subjects and researchers are not aware of the type of insole allocated. The person analyzing the data is unaware of the study and examines the data in general. N/A Intoeing gait pattern. Intervention 1: Intervention group1: The first group will receive a gate plate insole. It is a rigid plastic shell that covers the plantar area, with an extension beyond fourth and fifth metatarsal heads. Gate plate insoles were made-to-order and customized to the foot of each child. Children should use the insole for at least 4 hours a day for a month. Intervention 2: Intervention group2: The second group receive a medial-wedge insole. The medial-wedge insole with a height of 5 mm and an arch support extending from heel to toe made of ethylene-vinyl acetate were made-to-order and customized to the foot of each child. Children should use the insole for at least 4 hours a day for a month. 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 more information.
public Farzaneh Manouchehri
University of Social Welfare and Rehabilitation Science, Kodakyar Dead End, Daneshjou Blvd, Evin
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2000 fa.manouchehri@uswr.ac.ir University of social welfare and rehabilitation sciences scientific Farzaneh Manouchehri
University of Social Welfare and Rehabilitation Science, Kodakyar Dead End, Daneshjou Blvd, Evin
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2000 fa.manouchehri@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Pediatric population with an intoed gait In-toeing gait due to excessive femoral anteversion (internal rotation of the hip greater than 70 degrees) In-toeing gait due to internal tibia torsion (negative values ​​of thigh-foot angle) Angle of gait less than -3 degrees Being 3 to 10 years old 3 years 10 years Both In-toeing gait due to Cerebral Palsy In-toeing gait due to metatarsus adductus Severe deformities in lower limbs, for example, clubfoot, congenital hip joint dislocation, equinus of the foot and congenital flat foot History of surgery or fracture in lower limbs Neurological (Cerebral Palsy and Charcot Marie Thoth) and neuromuscular diseases Using medical shoes and orthoses Lack of children’s and/or parents’ consent to cooperate R26.8 Other abnormalities of gait and mobility Treatment - Devices Treatment - Devices Intervention group1: The first group will receive a gate plate insole. It is a rigid plastic shell that covers the plantar area, with an extension beyond fourth and fifth metatarsal heads. Gate plate insoles were made-to-order and customized to the foot of each child. Children should use the insole for at least 4 hours a day for a month. Intervention group2: The second group receive a medial-wedge insole. The medial-wedge insole with a height of 5 mm and an arch support extending from heel to toe made of ethylene-vinyl acetate were made-to-order and customized to the foot of each child. Children should use the insole for at least 4 hours a day for a month. Center of pressure displacement. Timepoint: Measurement of the displacement of center of pressure at the beginning of the study (before the intervention) and one month after using the gate plate insole or medial-wedge insole. Method of measurement: Force plate instrument. Velocity of center of pressure displacement. Timepoint: Measure the velocity of center of pressure displacement at the beginning of the study (before the intervention) and one month after using the gate plate insole or medial-wedge insole. Method of measurement: Force plate instrument. Angle of gait. Timepoint: Measure the angle of gait at the beginning of the study (before the intervention) and one month after using the gate plate insole or medial-wedge insole. Method of measurement: Motion analysis system. Shiraz University of Medical Sciences University of social welfare and rehabilitation sciences Shiraz University of Medical Sciences Approved 2020-09-12 Ethics committee of University of social Welfare and Rehabilitation Sciences University of Social Welfare and Rehabilitation Science, Kodakyar Dead End., Daneshjo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)