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IRCT20240906062959N1 IRCT 2024-12-11 University of social welfare and rehabilitation sciences Investigating the Effect of Heel Wedges on Gait Correction in Children with Joint Hypermobility Investigating the Immediate Effect of Using a Heel Wedge with Three Different Heights on Knee Hyperextension Caused by Joint Hypermobility. 2025-01-13 anticipated 15 Complete https://irct.ir/trial/79958 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 1 joint hyper mobility , genurecurvatum. Intervention Group: Shoes without heel and shoes with three different heights of 15 mm, 25 mm, and 35 mm, heel wedge. For each child in the intervention group, a pair of long boots made of synthetic leather will be prepared according to the length of their feet. The shoe design will incorporate a conventional orthopedic insole made of polyurethane that supports the longitudinal arch inside the shoe, and specially designed wedges for each size will be used in the external sole of the shoe. The design of the wedges will ensure that they end before the metatarsal heads, specifically at the break point of the shoe at the toe, reaching their minimum diameter. The wedges will be constructed with heights of 15 mm, 25 mm, and 35 mm at the heel. The height of the wedges on both the inner and outer sides will be equal to each other up to the end, starting from the heel and decreasing as it approaches the front of the foot, finishing before reaching the metatarsal heads. The design and construction of the wedges will be done using a molding device tailored to the shoe size by an orthotics specialist. Three heights for each size will be prepared that can be attached to the midsole of the shoe using double-sided tape. The children will be asked to wear the special shoes once without a wedge, once with a 15 mm heel wedge, once with a 25 mm heel wedge, and once with a 35 mm heel wedge. It is important to note that the order of wearing the shoes will be in a randomized block design. After assigning the type of height, measurements for each height will be taken with three repetitions. Each child will wear the shoes and the different heights of heel wedges in the specified order, and the walking test will be repeated three times for each height. A 20-second rest period will be provided between each intervention to prevent fatigue. 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 Maryam Hashemzadeh
University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak
Tehran Iran (Islamic Republic of) 1985713871 +98 21 7173 2832 hashemimaryam7071@gmail.com University of social welfare and rehabilitation sciences scientific Maryam Hashemzadeh
University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak
Tehran Iran (Islamic Republic of) 1985713871 +98 21 7173 2832 hashemimaryam7071@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) 5 to 10 years old children children With knee hyperextension greater than 10 degrees and less than 20 degrees Children with a Beighton score greater than 6 5 years 10 years Both Individuals with deformities in the lower limb joints and spine individuals who have experienced pain in the lower limb joints in the past two weeks individuals with anterior and posterior cruciate ligament tears individuals who have suffered a lower limb injury in the last six months individuals with a body mass index (BMI) above 25 Children under 5 years old and over 10 years old Treatment - Devices Intervention Group: Shoes without heel and shoes with three different heights of 15 mm, 25 mm, and 35 mm, heel wedge. For each child in the intervention group, a pair of long boots made of synthetic leather will be prepared according to the length of their feet. The shoe design will incorporate a conventional orthopedic insole made of polyurethane that supports the longitudinal arch inside the shoe, and specially designed wedges for each size will be used in the external sole of the shoe. The design of the wedges will ensure that they end before the metatarsal heads, specifically at the break point of the shoe at the toe, reaching their minimum diameter. The wedges will be constructed with heights of 15 mm, 25 mm, and 35 mm at the heel. The height of the wedges on both the inner and outer sides will be equal to each other up to the end, starting from the heel and decreasing as it approaches the front of the foot, finishing before reaching the metatarsal heads. The design and construction of the wedges will be done using a molding device tailored to the shoe size by an orthotics specialist. Three heights for each size will be prepared that can be attached to the midsole of the shoe using double-sided tape. The children will be asked to wear the special shoes once without a wedge, once with a 15 mm heel wedge, once with a 25 mm heel wedge, and once with a 35 mm heel wedge. It is important to note that the order of wearing the shoes will be in a randomized block design. After assigning the type of height, measurements for each height will be taken with three repetitions. Each child will wear the shoes and the different heights of heel wedges in the specified order, and the walking test will be repeated three times for each height. A 20-second rest period will be provided between each intervention to prevent fatigue Spatio-temporal parameters. Timepoint: The immediate effect is examined immediately after the intervention. Method of measurement: The calculation of spatial-temporal variables is performed using data obtained from the Vicon motion capture system (Vicon Motion Systems, Oxford, UK) with six cameras operating at a frequency of 120 Hz. The distance and time for each of the subphases of walking will be calculated through the software. Kinematics of the Ankle, Knee, and Hip Joints. Timepoint: The immediate effect is examined immediately after the intervention. Method of measurement: The calculation is performed using data obtained from the Vicon motion capture system (Vicon Motion Systems, Oxford, UK) with six cameras operating at a frequency of 120 Hz. This is done in such a way that after defining each segment, the variations in joint angles are calculated using software. Kinetics of the Ankle, Knee, and Hip Joints. Timepoint: The immediate effect is examined immediately after the intervention. Method of measurement: The torque generated around each joint is calculated using the data obtained from the force plate, which involves the ground reaction force multiplied by its distance from the center of the joint. Muscle Activity Pattern of the Knee Joint. Timepoint: The immediate effect is examined immediately after the intervention. Method of measurement: Muscle activity is measured using a 48-channel Aktos electromyography device manufactured by Myon, with bipolar surface electrodes synchronized with the force plate. University of social welfare and rehabilitation sciences Approved 2024-11-03 Ethics Committee of the University of social welfare and rehabilitation University of Rehabilitation Sciences and Health, Kudakiar Dead End, Daneshju Boulevard, Velenjak tehran Tehran Iran (Islamic Republic of)