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IRCT20170910036107N7 IRCT 2021-09-28 Iran University of Medical Sciences Comparison of the effect of medial longitudinal arch support with and without night Knee-Ankle-Foot orthosis (KAFO) on changes and correction of genu valgum in children less than ten years old Comparison of the effect of medial longitudinal arch support with and without night Knee-Ankle-Foot orthosis (KAFO) on changes and correction of genu valgum in children less than ten years old 2021-12-22 anticipated 20 Complete https://irct.ir/trial/58909 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups by Hidden sealed envelope randomization method. In such a way, an equal number of interventions are written in the same size sheets and the sheet is folded in such a way that the type of intervention is not clear. If the patient is selected for the study, parents will randomly pick up a sheet of envelope indicating the type of intervention. N/A Genu valgum. Intervention 1: First intervention group: knight Knee-Ankle-Foot orthosis (KAFO) with medial longitudinal arch support insole. Knight Knee-Ankle-Foot orthosis (KAFO) is made by measuring method. It is measured from the inside of the gluteal to the knee, from the knee to the ankle, and the length of each person's foot. Knight Knee-Ankle-Foot orthosis (KAFO) has a cuff in the thigh area and a Ankle-Foot orthosis (AFO) made of polyethylene, which are connected by two steel rods on both sides. The mechanism of action of knight Knee-Ankle-Foot orthosis (KAFO) is a system of three pressure points, two points of pressure on the outside of the foot and above and below the knee joint and one point on the opposite side in the area of the knee joint. In this orthosis, the knee is placed at a zero degree angle without movement and the ankle is placed at a 90 degree angle.The insole is made of polyurethane (PU) with medial longitudinal arch support, by scanning the feet of individuals. To make this insole Computer-aided design (CAD) and Computer-aided manufacturing (CAM) method is used. Intervention 2: Second intervention group: Medial longitudinal arch support insole.The insole is made of polyurethane (PU) with medial longitudinal arch support, by scanning the feet of individuals. To make this insole Computer-aided design (CAD) and Computer-aided manufacturing (CAM) method is used. 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 Narges Mahdizade
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 nargesmhz1369@gmail.com Iran University of Medical Sciences scientific Naseh Usefi
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 nasehusefi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Children 10 years and younger Angular deformity of the valgus around the knee in the coronal plate for no other reason than deformity such as trauma, or any neuromuscular disease no limit 10 years Both inflexible flat foot Physiological geno valgum History of lower limb bone surgery M21.06 Valgus deformity, not elsewhere classified, knee Treatment - Devices Treatment - Devices First intervention group: knight Knee-Ankle-Foot orthosis (KAFO) with medial longitudinal arch support insole. Knight Knee-Ankle-Foot orthosis (KAFO) is made by measuring method. It is measured from the inside of the gluteal to the knee, from the knee to the ankle, and the length of each person's foot. Knight Knee-Ankle-Foot orthosis (KAFO) has a cuff in the thigh area and a Ankle-Foot orthosis (AFO) made of polyethylene, which are connected by two steel rods on both sides. The mechanism of action of knight Knee-Ankle-Foot orthosis (KAFO) is a system of three pressure points, two points of pressure on the outside of the foot and above and below the knee joint and one point on the opposite side in the area of the knee joint. In this orthosis, the knee is placed at a zero degree angle without movement and the ankle is placed at a 90 degree angle.The insole is made of polyurethane (PU) with medial longitudinal arch support, by scanning the feet of individuals. To make this insole Computer-aided design (CAD) and Computer-aided manufacturing (CAM) method is used. Second intervention group: Medial longitudinal arch support insole.The insole is made of polyurethane (PU) with medial longitudinal arch support, by scanning the feet of individuals. To make this insole Computer-aided design (CAD) and Computer-aided manufacturing (CAM) method is used. Proximal medial tibia angle. Timepoint: Before the intervention and 6 months after treatment. Method of measurement: X-ray. Lateral femoral distal angle. Timepoint: Before the intervention and 6 months after treatment. Method of measurement: X-ray. Intercondylar distance. Timepoint: فاصله اینترکوندیلار. Method of measurement: X-ray. Lower limb length. Timepoint: Before the intervention and 6 months after treatment. Method of measurement: X-ray. Iran University of Medical Sciences Approved 2021-06-22 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)