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IRCT20250315065086N2 IRCT 2026-05-03 Esfahan University of Medical Sciences The impact of a specific type of insole on individuals with flat feet The Effect of Fascia bar-Incorporated insole on Pain, Foot Function, and Quality of Life in subjects with flexible flat foot and plantar fasciitis 2026-06-22 anticipated 48 Pending https://irct.ir/trial/89403 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will be conducted using random allocation with a block randomization method. A total sample of 48 participants will be organized into 12 blocks of four, with each block assigning two participants to the intervention group (P1) and two to the control group (P2), resulting in two equal groups of 24 participants each. The allocation sequence will be generated by an independent statistician and maintained in sequentially numbered, opaque, sealed envelopes. Following screening and informed consent, the corresponding envelope will be opened and the participant will be assigned to the respective group. Outcome assessors will be blinded to group allocation. Participants in group P1 will receive full-length foot orthoses with medial arch support and a fascia bar, while participants in group P2 will receive similar orthoses without a fascia bar. The blocks are written on paper, placed inside a container, and samples are selected via a draw, Blinding description: Participants in this study will be blinded, as they will be unable to distinguish between orthoses with a fascia bar and those without, due to their highly similar appearance. N/A Flatfoot. Intervention 1: The intervention group employs a full-length insole with an medial longitudinal arch support and a fascia bar. These insoles are custom-made and consist of two components: the heel section is constructed from foam with a hardness of 30 to 35, designed to absorb shock and reduce localized pressure, while the midfoot and forefoot sections are made from semi-rigid foam with a hardness of 40 to control pronation and provide support for the arch of the foot. The medial longitudinal arch support is anatomically designed to conform to the natural arch of the foot, preventing arch collapse and ensuring even pressure distribution. The insoles are made to be custom-fitted, meaning they are produced based on a prepared file that incorporates the fascia bar and adjusted solely according to the length of each participant’s foot. Furthermore, the thickness of the fascia bar is tailored to match each individual’s foot length.The fascia bar is positioned as a semi-cylindrical raise at the anterior heel and beneath the area where the calcaneus connects to the midtarsal region, measuring between 1.6 mm and 9.5 mm in thickness (with a maximum of 5 mm) and 13 mm to 64 mm in length. This structure is made from the same material as the body of the insole (foam) with a hardness of 35 to 40 (within the permissible range of 20 to 80) and continuously applies localized pressure at the heel-midfoot junction to reduce plantar fascia strain, consequently alleviating pain and enhancing foot function. The duration for using the insoles is four weeks, with a minimum recommended usage of six hours per day, and participants are instructed to refrain from other concurrent treatments or orthotic interventions during the study period.In the first session, after obtaining informed consent and completing a personal information questionnaire, participants receive a comprehensive explanation regarding the research introduction, benefits, and potential risks. In the second session, the insoles are provided free of charge, with instructions on proper use and necessary conditions for adherence to the wearing protocol. It is also noted that the manufacturer of the insoles is the Senrest Company in Isfahan. Participants are emphasized to ensure a minimum usage duration of six hours per day. Pain variable measurements are conducted at three intervals (prior to receiving the insoles, immediately after receipt, and four weeks post-receipt), while foot function and quality of life variables are assessed at two intervals (before receiving the insoles and four weeks after receipt). The researcher maintains weekly contact with participants via phone to check on their usage patterns and hours of insole application. Intervention 2: Control group:A full-length insole with medial longitudinal arch support, without a fascia bar. It is manufactured from the exact same material and design as the insole used in the Intervention Group, with the exception that it lacks the fascia bar prominence.These insoles are custom-made and consist of two components: the heel section is constructed from foam with a hardness of 30 to 35, designed to absorb shock and reduce localized pressure, while the midfoot and forefoot sections are made from semi-rigid foam with a hardness of 40 to control pronation and provide support for the arch of the foot. The medial longitudinal arch support is anatomically designed to conform to the natural arch of the foot, preventing arch collapse and ensuring even pressure distribution. The insoles are made to be custom-fitted.The duration for using the insoles is four weeks, with a minimum recommended usage of six hours per day, and participants are instructed to refrain from other concurrent treatments or orthotic interventions during the study period.In the first session, after obtaining informed consent and completing a personal information questionnaire, participants receive a comprehensive explanation regarding the research introduction, benefits, and potential risks. In the second session, the insoles are provided free of charge, with instructions on proper use and necessary conditions for adherence to the wearing protocol. It is also noted that the manufacturer of the insoles is the Senrest Company in Isfahan. Participants are emphasized to ensure a minimum usage duration of six hours per day. Pain variable measurements are conducted at three intervals (prior to receiving the insoles, immediately after receipt, and four weeks post-receipt), while foot function and quality of life variables are assessed at two intervals. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Saina Khatibi
Unit 7, No. 9, Villa Building, Villa Alley, Banafshah Miani Street, Khaneh Esfahan
Isfahan Iran (Islamic Republic of) 8194819398 +98 31 3420 4418 saina.khatibi1rehab@gmail.com Esfahan University of Medical Sciences scientific Saina Khatibi
Unit 7, No. 9, Villa Building, Villa Alley, Banafshah Miani Street, Khaneh Esfahan
Isfahan Iran (Islamic Republic of) 8194819398 +98 31 3420 4418 saina.khatibi1rehab@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 60 years History of symptoms consistent with plantar fasciitis for less than 6 months (acute phase) Presence of pain in the medial aspect of the heel Greater pain intensity upon first steps in the morning (first-step pain) A minimum pain intensity of 30 mm on a 100-mm Visual Analog Scale (VAS) during the past week Ability to use foot orthoses for at least 6 hours per day Positive Jack’s test: the appearance of the medial longitudinal arch during hallux dorsiflexion in a standing position, indicating arch flexibility Foot Posture Index (FPI) ≥ +6: the sum of scores from six criteria assessing foot posture in a standing position; a score ≥ +6 indicates a pronated or flexible foot Navicular Drop Test (NDT) ≥ 10 mm: the difference in navicular height between sitting and standing positions; a value greater than 10 mm indicates medial longitudinal arch collapse 18 years 60 years Both Use of foot orthoses, physiotherapy, or injections in the foot or ankle within the past 3 months History of lower limb surgery or planned surgery within the next 12 months Allergy to orthotic materials Cognitive impairment Medical history of diabetes mellitus (type I or II), inflammatory joint diseases, or neuromuscular disorders Pregnancy at the time of the study Presence of foot deformities History of foot or ankle fractures Body Mass Index (BMI) greater than 30 kg/m² M21.4 Flat foot [pes planus] (acquired) Treatment - Devices Placebo The intervention group employs a full-length insole with an medial longitudinal arch support and a fascia bar. These insoles are custom-made and consist of two components: the heel section is constructed from foam with a hardness of 30 to 35, designed to absorb shock and reduce localized pressure, while the midfoot and forefoot sections are made from semi-rigid foam with a hardness of 40 to control pronation and provide support for the arch of the foot. The medial longitudinal arch support is anatomically designed to conform to the natural arch of the foot, preventing arch collapse and ensuring even pressure distribution. The insoles are made to be custom-fitted, meaning they are produced based on a prepared file that incorporates the fascia bar and adjusted solely according to the length of each participant’s foot. Furthermore, the thickness of the fascia bar is tailored to match each individual’s foot length.The fascia bar is positioned as a semi-cylindrical raise at the anterior heel and beneath the area where the calcaneus connects to the midtarsal region, measuring between 1.6 mm and 9.5 mm in thickness (with a maximum of 5 mm) and 13 mm to 64 mm in length. This structure is made from the same material as the body of the insole (foam) with a hardness of 35 to 40 (within the permissible range of 20 to 80) and continuously applies localized pressure at the heel-midfoot junction to reduce plantar fascia strain, consequently alleviating pain and enhancing foot function. The duration for using the insoles is four weeks, with a minimum recommended usage of six hours per day, and participants are instructed to refrain from other concurrent treatments or orthotic interventions during the study period.In the first session, after obtaining informed consent and completing a personal information questionnaire, participants receive a comprehensive explanation regarding the research introduction, benefits, and potential risks. In the second session, the insoles are provided free of charge, with instructions on proper use and necessary conditions for adherence to the wearing protocol. It is also noted that the manufacturer of the insoles is the Senrest Company in Isfahan. Participants are emphasized to ensure a minimum usage duration of six hours per day. Pain variable measurements are conducted at three intervals (prior to receiving the insoles, immediately after receipt, and four weeks post-receipt), while foot function and quality of life variables are assessed at two intervals (before receiving the insoles and four weeks after receipt). The researcher maintains weekly contact with participants via phone to check on their usage patterns and hours of insole application. Control group:A full-length insole with medial longitudinal arch support, without a fascia bar. It is manufactured from the exact same material and design as the insole used in the Intervention Group, with the exception that it lacks the fascia bar prominence.These insoles are custom-made and consist of two components: the heel section is constructed from foam with a hardness of 30 to 35, designed to absorb shock and reduce localized pressure, while the midfoot and forefoot sections are made from semi-rigid foam with a hardness of 40 to control pronation and provide support for the arch of the foot. The medial longitudinal arch support is anatomically designed to conform to the natural arch of the foot, preventing arch collapse and ensuring even pressure distribution. The insoles are made to be custom-fitted.The duration for using the insoles is four weeks, with a minimum recommended usage of six hours per day, and participants are instructed to refrain from other concurrent treatments or orthotic interventions during the study period.In the first session, after obtaining informed consent and completing a personal information questionnaire, participants receive a comprehensive explanation regarding the research introduction, benefits, and potential risks. In the second session, the insoles are provided free of charge, with instructions on proper use and necessary conditions for adherence to the wearing protocol. It is also noted that the manufacturer of the insoles is the Senrest Company in Isfahan. Participants are emphasized to ensure a minimum usage duration of six hours per day. Pain variable measurements are conducted at three intervals (prior to receiving the insoles, immediately after receipt, and four weeks post-receipt), while foot function and quality of life variables are assessed at two intervals Pain Intensity Score. Timepoint: Before receiving the insoles, immediately after receiving the insoles, and four weeks after receiving the insoles. Method of measurement: Visual Analogue Scale. Foot Function Score. Timepoint: Before receiving the insoles and four weeks after receiving the insoles. Method of measurement: Foot Function Index questionnaire. Quality of Life Score. Timepoint: Before receiving the insoles and four weeks after receiving the insoles. Method of measurement: Orthotics and Prosthetics Users’ Survey – Satisfaction Module questionnaire. Esfahan University of Medical Sciences Approved 2026-03-03 Ethics Committee of Isfahan University of Medical Sciences Research and Technology Deputy, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)