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IRCT20240405061417N1 IRCT 2024-08-06 Iran University of Medical Sciences Comparison of the effect of two types of offloading insoles on the balance of patients with diabetic foot ulcers Comparision between puzzle insole and conventional four-layer insole with offloading rocker sole shoe on dynamic balance and spatio-temporal parameters of gait in patients with diabetic foot ulcers 2024-06-21 anticipated 15 Complete https://irct.ir/trial/76333 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this cross-over study, the sequence of interventions and experimental conditions will be randomly determined as follows: First, a list of all participants will be prepared. Then, a random number generation software will be utilized to determine the sequential order for each participant. For this purpose, randomization algorithms available in R software will be used. Each participant will be assigned a unique random number that specifies the order of interventions and experimental conditions. The process will involve assigning even numbers to one order and odd numbers to another. The results of the random assignment will be documented in separate tables, and the final order for each participant will remain confidential, with no review by other researchers, to ensure fair and random allocation. N/A Diabetic polyneuropathy. Intervention 1: Intervention group: offloading shoes with a 20-degree rocker sole with a conventional four-layer insole. Rocker insole shoe is a type of footwear modification where the sole of the shoe is curved. Its purpose is to allow the body's center of mass to roll over the support surface. The conventional four-layer insole used in this research consists of an upper layer of plastazote with a hardness of A30 in contact with the foot, a polyethylene foam layer with a hardness of A40 as the second layer, a polyethylene foam layer with a hardness of A50 as the third layer, and a shear force reduction layer made of pron located underneath all the layers. Intervention 2: Intervention group: offloading shoes with a 20-degree rocker sole with a puzzle four-layer insole. Rocker insole shoe is a type of footwear modification where the sole of the shoe is curved. Its purpose is to allow the body's center of mass to roll over the support surface. The conventional four-layer insole used in this research consists of an upper layer of plastazote with a hardness of A30 in contact with the foot, a polyethylene foam layer with a hardness of A40 as the second layer, a polyethylene foam layer with a hardness of A50 as the third layer, and a shear force reduction layer made of pron located underneath all the layers. Intervention 3: Control group: The patient's own shoes, which are low top with flat insoles. 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 It will be decided according to the journal's policies or other ways of publication in the future and in consultation with the research team
public Akram Tadi Beni
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
Tehran Iran (Islamic Republic of) 15459 13487 +98 21 2640 5626 tadibeni.a@iums.ac.ir Iran University of Medical Sciences scientific Dr Hassan Saeedi
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran
Tehran Iran (Islamic Republic of) 15459 13487 +98 21 2222 2059 hassan-saeedi@yahoo.co.uk Iran University of Medical Sciences Iran (Islamic Republic of) Diabetic patients with foot ulcers only due to neuropathy The ulcer of the forefoot The maximum size of the ulcer is 2x2 cmm The age of patients should be between 40 and 60 years Diabetic foot ulcer is shallow No amputation of fingers Absence of disease due to imbalance such as Parkinson's, MS, vestibular disorders or similar cases Not taking drugs that affect balance Have no history of using the researched off-loading shoes 40 years 60 years Both The ulcer is on the foot or leg or in the hindfoot The vascular ulcers or neurovascular ulcers The ulcer has involved the bone G63.2 Diabetic polyneuropathy Rehabilitation Rehabilitation Other Intervention group: offloading shoes with a 20-degree rocker sole with a conventional four-layer insole. Rocker insole shoe is a type of footwear modification where the sole of the shoe is curved. Its purpose is to allow the body's center of mass to roll over the support surface. The conventional four-layer insole used in this research consists of an upper layer of plastazote with a hardness of A30 in contact with the foot, a polyethylene foam layer with a hardness of A40 as the second layer, a polyethylene foam layer with a hardness of A50 as the third layer, and a shear force reduction layer made of pron located underneath all the layers. Intervention group: offloading shoes with a 20-degree rocker sole with a puzzle four-layer insole. Rocker insole shoe is a type of footwear modification where the sole of the shoe is curved. Its purpose is to allow the body's center of mass to roll over the support surface. The conventional four-layer insole used in this research consists of an upper layer of plastazote with a hardness of A30 in contact with the foot, a polyethylene foam layer with a hardness of A40 as the second layer, a polyethylene foam layer with a hardness of A50 as the third layer, and a shear force reduction layer made of pron located underneath all the layers. Control group: The patient's own shoes, which are low top with flat insoles Step width: It means the distance between the line of progress of the left foot and the line of progress of the right foot. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. Step legnth: The length measured parallel to the forward line of the body from the heel contact of one foot to the heel contact of the other foot. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. Step time: The time interval between the heel contact of one foot with the ground and the heel contact of the opposite foot with the ground. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. Stance time percentage :This phase starts when the foot is in contact with the ground and with the complete separation of the same foot from the groundIt ends. The stance phase constitutes approximately 60% of the walking phase. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. The time percentage of the midstance phase: in observation; This phase of walking starts with the separation of the toes of the opposite foot from the ground and continues until the heel of the progressive foot is in contact with the ground and accounts for 29 to 37% of walking. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. The number of steps per unit of time (cadence): is the frequency of steps. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. Lateral shift of the center of pressure: indicating the movement direction of the center of pressure to the left and right. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. Anterior-posterior shift of the center of pressure: the direction of movement of the center of pressure is anterior-posterior. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. Standard deviation of the center of pressure: The standard deviation of the center of pressure is obtained by calculating the displacement of all steps. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software. Iran University of Medical Sciences Approved 2023-07-31 Ethics committee of Iran University of Medical Sciences Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran Tehran Tehran Iran (Islamic Republic of)