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IRCT20211030052916N2 IRCT 2025-05-13 Esfahan University of Medical Sciences Textured insole and vibrating insole on balance and gait parameters of people with Parkinson's disease The effect of textured insoles compared with vibrating insoles on spatio-temporal parameters of gait, static and dynamic balance in people with Parkinson's disease 2025-06-22 anticipated 16 Complete https://irct.ir/trial/83224 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: Block randomization Randomization tool: Draw by paper selection Randomization method: In order to control confounding variables, participants are randomly assigned to two equal test groups (1- vibrating insole 2- textured insole). The random assignment method in both groups is as follows: the size of each block is 4 people, and accordingly, by considering two groups (textured insole = P1, vibrating insole = P2), 6 blocks are obtained. These blocks are written separately on paper and poured into a container, and 8 people are selected for each group by drawing lots, and 16 people in total. N/A Parkinson disease. Intervention 1: Intervention group one: Patients with Parkinson's who use a textured insole. The textured insole will consist of four main parts: the base insole, a 15 mm medial longitudinal arch, a heel cup (made of foam with a hardness of A50), and a textured surface on the insole. This insole is full-length and covers the heel area to the ends of the toes. This insole is prepared for people with Parkinson's based on the patient's foot measurements (toe and heel width, foot length, and medial longitudinal arch length) by a prosthetic orthotist at the Technical Orthopedic Clinic of the Faculty of Rehabilitation Sciences of Isfahan University of Medical Sciences. In fact, the upper surface of the insole has a textured design of 5 mm in height and 2 mm in thickness and is in contact with the patient's sole. The reason for this choice is the report of previous research on the stimulation of mechanoreceptors in the sole of the foot. Each Parkinson's patient selected for the study wore a pair of textured insoles and underwent laboratory tests twice (once immediately after wearing the textured insoles and the second time, one week after using the textured insoles). The method of using the textured insole is that the patient places the insole inside his shoe and immediately performs the research-related tests, and after using the insole inside the shoe for a week, he performs the research tests again. The duration of use of the textured insole is such that the patient uses the textured insole inside the shoe whenever he wants to walk inside or outside the house. Intervention 2: Second intervention group: Patients with Parkinson's who use a vibrating insole. In this study, the vibrating insole will have two main parts (static and vibration system). The static part is a prefabricated insole and includes three main parts: the base insole, the internal longitudinal arch with a height of 15 mm, and the heel cup (made of foam with a stiffness of A50). This insole is full-length and covers the heel to the tips of the toes. This insole is prepared for people with Parkinson's based on the patient's foot measurements (toe and heel width, foot length, and internal longitudinal arch length) by a prosthetic orthotist and in the Technical Orthopedic Clinic of the Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences. The vibration system of the vibrating insole includes vibration motors, a control center, and a power supply. Mechanical vibration motors with a diameter of 8 mm, a thickness of 2.7 mm, and a durable steel material will be embedded in the prefabricated insole and will be used as the vibration actuator of the vibrating insole. The mechanical vibration motors will be placed under the heads of the 1st and 5th metatarsals and the heel area. The vibration motors will be connected to the control center via flexible wires with a diameter of 1 mm made of silver fiber. A dedicated electronic circuit will be designed to adjust the type and level of vibration. The power source will be a lithium battery. The battery and control circuit will be placed in a box that will be fastened with a strap to the top and outside of the person's ankle. Each Parkinson's patient selected for the study will wear a pair of vibrating insoles and perform laboratory tests twice (once immediately after wearing the vibrating insoles and the second time, one week after using the vibrating insoles). The method of using the vibrating insole is that the patient places the insole inside his shoe and immediately performs the research-related tests, and after using the insole inside the shoe for a week, he performs the research tests again. The duration of use of the vibrating insole is such that whenever the patient wants to walk inside or outside the house, he uses the textured insole inside the shoe. 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 After the completion of the research and the final opinion of the research team, including the first supervisor, second supervisor, advisor, statistics professor, and student, the publication or non-publication of the data and participant files will be determined.
public Amirhossein Zare
School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezarjerib Street, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5020 zareamirhossein75@yahoo.com Esfahan University of Medical Sciences scientific Masoud Rafiaei
School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezarjerib Street, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3669 3089 ma.rafiaei@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) People with mild to moderate Parkinson's or grades 2 and 3 on the Hohen-Yarn scale Patients can walk without assistive devices in their daily activities Idiopathic Parkinson's patients without comorbidities Patients with idiopathic Parkinson's disease whose Body Mass Index (BMI) is between 25 and 35 Kg/m2 60 years 70 years Both Uncorrected visual impairment Postural hypotension Known orthopedic or arthritic disease affecting gait Any deformity of the lower extremities (hip, knee, ankle, and foot) that affects the patient's gait G20 Parkinson's disease Treatment - Devices Treatment - Devices Intervention group one: Patients with Parkinson's who use a textured insole. The textured insole will consist of four main parts: the base insole, a 15 mm medial longitudinal arch, a heel cup (made of foam with a hardness of A50), and a textured surface on the insole. This insole is full-length and covers the heel area to the ends of the toes. This insole is prepared for people with Parkinson's based on the patient's foot measurements (toe and heel width, foot length, and medial longitudinal arch length) by a prosthetic orthotist at the Technical Orthopedic Clinic of the Faculty of Rehabilitation Sciences of Isfahan University of Medical Sciences. In fact, the upper surface of the insole has a textured design of 5 mm in height and 2 mm in thickness and is in contact with the patient's sole. The reason for this choice is the report of previous research on the stimulation of mechanoreceptors in the sole of the foot. Each Parkinson's patient selected for the study wore a pair of textured insoles and underwent laboratory tests twice (once immediately after wearing the textured insoles and the second time, one week after using the textured insoles). The method of using the textured insole is that the patient places the insole inside his shoe and immediately performs the research-related tests, and after using the insole inside the shoe for a week, he performs the research tests again. The duration of use of the textured insole is such that the patient uses the textured insole inside the shoe whenever he wants to walk inside or outside the house. Second intervention group: Patients with Parkinson's who use a vibrating insole. In this study, the vibrating insole will have two main parts (static and vibration system). The static part is a prefabricated insole and includes three main parts: the base insole, the internal longitudinal arch with a height of 15 mm, and the heel cup (made of foam with a stiffness of A50). This insole is full-length and covers the heel to the tips of the toes. This insole is prepared for people with Parkinson's based on the patient's foot measurements (toe and heel width, foot length, and internal longitudinal arch length) by a prosthetic orthotist and in the Technical Orthopedic Clinic of the Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences. The vibration system of the vibrating insole includes vibration motors, a control center, and a power supply. Mechanical vibration motors with a diameter of 8 mm, a thickness of 2.7 mm, and a durable steel material will be embedded in the prefabricated insole and will be used as the vibration actuator of the vibrating insole. The mechanical vibration motors will be placed under the heads of the 1st and 5th metatarsals and the heel area. The vibration motors will be connected to the control center via flexible wires with a diameter of 1 mm made of silver fiber. A dedicated electronic circuit will be designed to adjust the type and level of vibration. The power source will be a lithium battery. The battery and control circuit will be placed in a box that will be fastened with a strap to the top and outside of the person's ankle. Each Parkinson's patient selected for the study will wear a pair of vibrating insoles and perform laboratory tests twice (once immediately after wearing the vibrating insoles and the second time, one week after using the vibrating insoles). The method of using the vibrating insole is that the patient places the insole inside his shoe and immediately performs the research-related tests, and after using the insole inside the shoe for a week, he performs the research tests again. The duration of use of the vibrating insole is such that whenever the patient wants to walk inside or outside the house, he uses the textured insole inside the shoe. Walking speed. Timepoint: Time periods for measuring study parameters: at the beginning of the study (before the intervention), immediately after the intervention (baseline), and 7 days after the intervention (baseline). Method of measurement: Specialized gait analysis laboratory, force plate device and force plate evaluator. Stride Length. Timepoint: Time periods for measuring study parameters: at the beginning of the study (before the intervention), immediately after the intervention (baseline), and 7 days after the intervention (baseline). Method of measurement: Specialized gait analysis laboratory, force plate device and force plate evaluator. Cadence. Timepoint: Time periods for measuring study parameters: at the beginning of the study (before the intervention), immediately after the intervention (baseline), and 7 days after the intervention (baseline). Method of measurement: Specialized gait analysis laboratory, force plate device and force plate evaluator. Average displacement of the center of pressure. Timepoint: Time periods for measuring study parameters: at the beginning of the study (before the intervention), immediately after the intervention (baseline), and 7 days after the intervention (baseline). Method of measurement: Specialized gait analysis laboratory, force plate device and force plate evaluator. Average displacement of the body's center of mass. Timepoint: Time periods for measuring study parameters: at the beginning of the study (before the intervention), immediately after the intervention (baseline), and 7 days after the intervention (baseline). Method of measurement: Specialized gait analysis laboratory, force plate device and force plate evaluator. Esfahan University of Medical Sciences Approved 2025-04-29 Research Ethics Committees of Nursing, Rehabilitation & Management schools Research Ethics Committees of Nursing, Rehabilitation & Management Schools, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)