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IRCT20241110063658N1 IRCT 2025-01-15 Shahid Beheshti University of Medical Sciences Insoles and exercise therapy for people with flat feet Effect of foot orthosis and short foot exercise on morphological characteristics of the intrinsic muscles of foot and plantar fascia in individuals with flexible flatfoot 2025-01-19 anticipated 30 Complete https://irct.ir/trial/80352 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is performed using sealed envelopes, in which a box contains 30 envelopes, 15 envelopes labeled A and 15 envelopes labeled B, and patients are asked to choose one envelope. The letter A is placed in the foot orthosis alone group and the letter B is placed in the foot orthosis and leg shortening exercise group, Blinding description: Ultrasound evaluations are done by a person who does not know about the groupings and a statistician who is also blind to the groupings. N/A Flat foot. Intervention 1: Control group: orthosis group alone. The CNC orthosis is scanned and made in static mode through the initial scan of the foot by the Danesh Salar scanner. The full-length orthosis has an internal longitudinal arch and metatarsal pad and is made of semi-hard EVA foam. Participants in both control and intervention groups will receive the orthosis and wear it outdoors for at least 6 hours a day for 8 weeks in walking and sports shoes. The control group does not participate in any ankle and foot exercises. Intervention 2: Intervention group: Intervention group: group of orthosis and exercise together. The participants in the intervention group also receive the orthosis and use it for at least 6 hours a day for 8 weeks in walking and sports shoes, and in addition to the foot orthosis, they do short foot exercise without shoes, insoles and with bare feet in a standing position. It is performed on one leg next to the wall in a position where the index finger is connected to the wall to keep the balance of the body and the knee of the other leg is in flexion. in such a way that they raise the internal longitudinal arch and shorten the length of the leg in the anterior-posterior direction and move the head of the first metatarsal to the heel; Without flexing the fingers. Exercises are repeated daily, twice a day in 3 sets of 5. In each repetition, the arch is held for 5 seconds and there is a 2 minute rest between each set. After one to two weeks of training, if the participants were able to hold the contraction without falling down the navicular tuberosity, the duration of holding will increase from 5 to 10 and the number of sets will increase from 3 to 5 sets. 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 Data collection has not been done yet, if all patients are satisfied, there is a plan to release it.
public Parand Vosoughi
Tehran, Imam Hossein Square, Damavand Street, in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 parandvosoughi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Parand Vosoughi
Tehran, Imam Hossein (AS) Square, Damavand Street, in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid University of Medical Sciences
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 parandvosoughi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Adults with flexible flatfoot The presence of heel valgus Ages 18 to 40 Foot posture index score 6 and greater than 6 Body mass index in the normal range (24.9-18.5) 18 years 40 years Both Rigid flatfoot Posterior tibial tendon disfunction and acquired flatfoot due to trauma Severe degree of hallux valgus Plantar fasciitis Ankle instability Knee genu varum History of trauma and orthopedic surgery in the last 6 months pregnancy Orthopedic and inflammatory diseases History of using foot orthosis or performing foot exercises in the 6 months before the study M21.4 Flat foot [pes planus] (acquired) Rehabilitation Rehabilitation Control group: orthosis group alone. The CNC orthosis is scanned and made in static mode through the initial scan of the foot by the Danesh Salar scanner. The full-length orthosis has an internal longitudinal arch and metatarsal pad and is made of semi-hard EVA foam. Participants in both control and intervention groups will receive the orthosis and wear it outdoors for at least 6 hours a day for 8 weeks in walking and sports shoes. The control group does not participate in any ankle and foot exercises. Intervention group: Intervention group: group of orthosis and exercise together. The participants in the intervention group also receive the orthosis and use it for at least 6 hours a day for 8 weeks in walking and sports shoes, and in addition to the foot orthosis, they do short foot exercise without shoes, insoles and with bare feet in a standing position. It is performed on one leg next to the wall in a position where the index finger is connected to the wall to keep the balance of the body and the knee of the other leg is in flexion. in such a way that they raise the internal longitudinal arch and shorten the length of the leg in the anterior-posterior direction and move the head of the first metatarsal to the heel; Without flexing the fingers. Exercises are repeated daily, twice a day in 3 sets of 5. In each repetition, the arch is held for 5 seconds and there is a 2 minute rest between each set. After one to two weeks of training, if the participants were able to hold the contraction without falling down the navicular tuberosity, the duration of holding will increase from 5 to 10 and the number of sets will increase from 3 to 5 sets. "Plantar fascia angle with the horizontal axis". Timepoint: The beginning of the study before the intervention and 8 weeks after using the intervention. Method of measurement: Ultrasonography. "Abductor hallucis muscle thickness". Timepoint: The beginning of the study before the intervention and 8 weeks after using the intervention. Method of measurement: Ultrasonography. "Abductor hallucis muscle cross section area". Timepoint: The beginning of the study before the intervention and 8 weeks after using the intervention. Method of measurement: Ultrasonography. "Flexor hallucis brevis muscle thickness". Timepoint: The beginning of the study before the intervention and 8 weeks after using the intervention. Method of measurement: Ultrasonography. "Flexor hallucis brevis muscle cross section area". Timepoint: The beginning of the study before the intervention and 8 weeks after using the intervention. Method of measurement: Ultrasonography. "foot posture index score". Timepoint: The beginning of the study before the intervention and 8 weeks after using the intervention. Method of measurement: Observation. Shahid Beheshti University of Medical Sciences Approved 2024-10-16 Ethics Committee of Shahid Beheshti University of Medical Sciences Tehran, Valenjak, Daneshjoo Blvd., Arabi St.,Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)