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IRCT20250506065623N1 IRCT 2025-08-25 University of Tehran The effects of exercise with arch support insole on flexible flatfoot The effects of a comprehensive exercise program with arch support insole on foot alignment and kinematic variables of gait in individuals with flexible flatfoot 2025-06-27 anticipated 30 Complete https://irct.ir/trial/83361 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After the initial assessments, the people will be randomly assigned to one of the three groups of comprehensive exercise program with arch support insole, only use of arch support insole and control group (method: simple randomization - unit: individual). An envelope containing blue paper, an envelope containing red paper and another envelope containing yellow paper (randomization tool: sealed envelope) will be given to each person. Each person choosing the envelope containing blue or red or yellow paper will be assigned to the comprehensive exercise program with arch support insole group or only use of arch support insole group or control group, respectively. N/A flexible flatfoot. Intervention 1: "Intervention Group 1": This group performs comprehensive exercises with arch support insole under the supervision of the researcher. Comprehensive exercises program includes active exercises (dorsiflexion and plantarflexion), short foot exercises (lesser toe extension, toe spread, doming and hallux extension), gluteal muscle strengthening exercises (hip abduction, hip extension) and calf stretches. Exercises progress after 2 weeks with alteration in the position (i.e., sitting, standing and single-leg stance) and/or an increase in hold time and number of repetitions. The intervention is performed at three sessions per week for 8 weeks. The three session per week are prescribed to occur on Monday, Wednesday and Friday. The medical insole used is a custom insole that is made for each individual through three-dimensional (3D)-printed and computer-aided design/computer-aided manufacturing (CAD/CAM) technology from semi-rigid foam in an orthopedic Clinic in Tehran. The necessary measurements will be performed as a pre-test for all subjects, and after 8 weeks of intervention, the measurements will be repeated as a post-test. Intervention 2: "Intervention Group 2": This group will use only a pair of custom arch support insole for 8 weeks. These insoles are designed with an internal longitudinal arch that aligns with the individual’s foot arch corresponding to the size of each participant’s foot through three-dimensional (3D)-printed and computer-aided design/computer-aided manufacturing (CAD/CAM) technology from semi-rigid foam at an orthopedic Clinic in Tehran. The necessary measurements will be taken as a pre-test for all subjects, and after 8 weeks of intervention, the measurements will be repeated as a post-test. Intervention 3: "Control group": The control group does not perform any of the intervention group programs. The necessary measurements will be taken as a pre-test for all subjects, and after 8 weeks, the measurements will be repeated as a post-test. In order to comply with research ethics, after the completion of the research work, if the corrective exercises and the use of arch support insole were effective, we will give the control group the exercises and the use of arch support insole. 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 Seyyed Ghasem Hosseini
Faculty of Physical Education and Sport Sciences, North Kargar street
Tehran Iran (Islamic Republic of) 1439813117 +98 21 8835 1730 s.gh.hosseini@ut.ac.ir University of Tehran scientific Seyyed Ghasem Hosseini
Faculty of Physical Education and Sport Sciences, North Kargar street
Tehran Iran (Islamic Republic of) 1439813117 +98 21 8835 1730 s.gh.hosseini@ut.ac.ir University of Tehran Iran (Islamic Republic of) Male high school students, have an age range of 13 to 15 years. All subjects have flat flexible feet with a navicular drop greater than 10 mm, a medial longitudinal arch angle less than 130 degrees, and a eversion angle greater than or equal to 5 degrees. 13 years 15 years Male Having any physical injury in the past four months Having pathological symptoms in the lower limbs Having a body weight outside the normal range Having any congenital abnormality in the lower limbs Having any congenital abnormality in the pelvis M21.4 Flat foot [pes planus] (acquired) Rehabilitation Rehabilitation Rehabilitation "Intervention Group 1": This group performs comprehensive exercises with arch support insole under the supervision of the researcher. Comprehensive exercises program includes active exercises (dorsiflexion and plantarflexion), short foot exercises (lesser toe extension, toe spread, doming and hallux extension), gluteal muscle strengthening exercises (hip abduction, hip extension) and calf stretches. Exercises progress after 2 weeks with alteration in the position (i.e., sitting, standing and single-leg stance) and/or an increase in hold time and number of repetitions. The intervention is performed at three sessions per week for 8 weeks. The three session per week are prescribed to occur on Monday, Wednesday and Friday. The medical insole used is a custom insole that is made for each individual through three-dimensional (3D)-printed and computer-aided design/computer-aided manufacturing (CAD/CAM) technology from semi-rigid foam in an orthopedic Clinic in Tehran. The necessary measurements will be performed as a pre-test for all subjects, and after 8 weeks of intervention, the measurements will be repeated as a post-test. "Intervention Group 2": This group will use only a pair of custom arch support insole for 8 weeks. These insoles are designed with an internal longitudinal arch that aligns with the individual’s foot arch corresponding to the size of each participant’s foot through three-dimensional (3D)-printed and computer-aided design/computer-aided manufacturing (CAD/CAM) technology from semi-rigid foam at an orthopedic Clinic in Tehran. The necessary measurements will be taken as a pre-test for all subjects, and after 8 weeks of intervention, the measurements will be repeated as a post-test. "Control group": The control group does not perform any of the intervention group programs. The necessary measurements will be taken as a pre-test for all subjects, and after 8 weeks, the measurements will be repeated as a post-test. In order to comply with research ethics, after the completion of the research work, if the corrective exercises and the use of arch support insole were effective, we will give the control group the exercises and the use of arch support insole. Navicular drop (cm). Timepoint: Measurement of navicular drop (cm) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: ruler. Medial longitudinal arch angle (degree). Timepoint: Measurement of medial longitudinal arch angle (degree) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: goniometer. Eversion angle (degree). Timepoint: Measurement of eversion angle (degree) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: goniometer. Stride length (cm). Timepoint: Measurement of Stride length (cm) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Step length (cm). Timepoint: Measurement of Step length (cm) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Width length (cm). Timepoint: Measurement of width length (cm) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Foot progression angle (degree). Timepoint: Measurement of foot progression angle (degree) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Stride time (s). Timepoint: Measurement of Stride time (s) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Step time (s). Timepoint: Measurement of Step time (s) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Double support time (s). Timepoint: Measurement of double support time (s) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Single support time (s). Timepoint: Measurement of single support time (s) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Cadence (steps/min). Timepoint: Measurement of Cadence (steps/min) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Hallux Relative to the forefoot (degree). Timepoint: Measurement of hallux Relative to the forefoot (degree) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Forefoot Relative to the hindfoot (degree). Timepoint: Measurement of forefoot Relative to the hindfoot (degree) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Hindfoot relative to tibia(degree). Timepoint: Measurement of hindfoot relative to tibia(degree) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. Tibia relative to the laboratory (degree). Timepoint: Measurement of tibia relative to the laboratory (degree) at the beginning of the study, before the start of the 8-week intervention, and immediately after the end of the intervention. Method of measurement: A3-dimensional motion analysis system. University of Tehran Approved 2025-04-28 Ethics Committee, University of Tehran, Faculty of Sport and Health Sciences Faculty of Physical Education and Sport Sciences, North Kargar street Tehran Tehran Iran (Islamic Republic of)