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IRCT20260810070608N1 IRCT 2026-08-24 Iran University of Medical Sciences Effect of interventions on flatfoot Comparison of the Immediate Effects of Foot Insole and Kinesio Taping on Postural Stability Using the Double-Leg to Single-Leg Stance Transition Test in Adults with Flexible Flatfoot 2026-09-05 anticipated 30 Recruiting https://irct.ir/trial/92416 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: This study will employ a randomized, three-period, three-treatment crossover design. Eligible participants will be randomly assigned to one of six possible intervention sequences (IBT, ITB, BIT, BTI, TIB, TBI) in a 1:1:1:1:1:1 allocation ratio using a permuted block randomization method with a fixed block size of six. Each block will contain all six sequences exactly once in a randomly determined order. Five complete blocks will be generated to achieve the target sample size of 30 participants. To ensure allocation concealment, group assignments will be placed in sequentially numbered, opaque, sealed envelopes by an independent administrator. Envelopes will be opened sequentially only after participant enrollment and completion of all baseline procedures, immediately before the first intervention session. N/A Flexible flatfoot. Intervention 1: Insole condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period). Intervention 2: Kinesio tape condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period). Intervention 3: No intervention condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period). 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 No information
public Amir Mohammad Shooryabi
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
Tehran Iran (Islamic Republic of) 1348715459 +98 21 2222 8051 amirshooryabi5@gmail.com Iran University of Medical Sciences scientific Fatemeh Azadinia
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
Tehran Iran (Islamic Republic of) 1348715459 +98 21 2222 7124 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Age between 18–35 years Ability to stand and walk Bilateral flatfoot BMI less than 30 Foot Posture Index (FPI-6) score ≥ +6 Navicular Drop Test ≥ 10 mm Able to read and write in Persian Moderate physical activity level (IPAQ questionnaire) 18 years 35 years Both Foot deformities (hallux valgus, hammer toe, etc.) and vestibular disorders Use of medications/substances affecting the central nervous system History of musculoskeletal injury within the last 6 months High-intensity physical activity within 12 hours before test M21.4 Flat foot [pes planus] (acquired) Treatment - Other Treatment - Other N/A Insole condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period). Kinesio tape condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period). No intervention condition. Due to the crossover design of this study, this group represents one of the 3 conditions available. All 30 participants in the study receive this condition according to the sequence group to which they are assigned. This study has a total of 6 sequence groups, which determine the order in which the conditions (insole, Kinesio tape, no intervention) are received in each session.To evaluate the immediate effect of the condition, the participant performs the test 30 minutes after receiving the condition (familiarization period). The mean of COP displacement. Timepoint: Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session. Method of measurement: Force plate, model 9260AA6, manufactured by Kistler. Mean absolute COP velocity. Timepoint: Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session. Method of measurement: Force plate, model 9260AA6, manufactured by Kistler. Mean peak absolute COP velocity. Timepoint: Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session. Method of measurement: Force plate, model 9260AA6, manufactured by Kistler. Mean COP displacement during contralateral push-off phase. Timepoint: Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session. Method of measurement: Force plate, model 9260AA6, manufactured by Kistler. Mean COP excursion range during contralateral push-off phase. Timepoint: Assessments will be performed immediately after a 30-minute period(familiarization) following the application of each intervention, across 3 sessions with different conditions, each separated by an interval of at least 24 hours from the previous session. Method of measurement: Force plate, model 9260AA6, manufactured by Kistler. Temporal parameters during transition task including mean time to new stability point, mean duration of contralateral limb push-off phase. Timepoint: Assessments will be performed in each session, under one of (control/no intervention; insole; kinesio tape) conditions, a 24-hours washout period will be considered between sessions. There will be a 30-minute familiarization time with interventions in each session. Method of measurement: force plate. Iran University of Medical Sciences Approved 2026-07-22 School of Rehabilitation Sciences, Iran University of Medical Sciences School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv. Tehran Tehran Iran (Islamic Republic of)