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IRCT20210712051853N1 IRCT 2021-08-09 Esfahan University of Medical Sciences Evaluation of the effect of night orthosis on foot and ankle biomechanics in children with flexible flatfoot and gastro-soleus stiffness Evaluation of the effect of night orthosis on foot and ankle biomechanics in children with flexible flatfoot and gastro-soleus stiffness: Based on Randomized clinical trial 2021-07-23 anticipated 20 Complete https://irct.ir/trial/57444 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This feature helps us to equalize the size of all blocks in cases where intermediate analyzes are required during the sampling process. In this two-group clinical trial where the size of the blocks is equal, we will have 10 subjects in the intervention group and 10 subjects in the control group. Random allocation software is used, which in addition to simple randomization, can produce Random sequences that are block-making. For allocation concealment, which refers to the method used to execute random sequences on study participants so that the assigned group is not known before the individual is assigned. The opaque sealed envelopes in random sequences were used. In this method, each of the random sequences created is recorded on a card, and the cards are placed in the letter envelopes in order. To maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lid of the letter envelopes is glued and placed inside the box, respectively. At the beginning of the registration of the subjects, according to the order of entry of the eligible participants, one of the envelopes will be opened to determine the assigned group of the participant, Blinding description: This is a one-way blinded study and participants will be blinded to the type of treatment that can be exercise or exercise with orthosis. N/A flexible flatfoot with gasrtosoleus stiffness. Intervention 1: Intervention group: Night orthoses are made of similar 5 mm polypropylene in two pieces, hinged ankle joint, with an extension in the popliteal area and without a joint for the knee, So, the knee will be straight at night and the gastrocnemius muscle will be stretched effectively by dorsiflexion of the ankle joint. The hinge ankle joint of the orthosis is adjusted at the angle of the maximum amount of tolerable dorsiflexion for each subject (that it does not cause pain or discomfort). A goniometer is placed on the ankle joint to measure the dorsiflexion angle. The ankle is placed at the maximum tolerable dorsiflexion angle for maximum stretching on the gastro-soleus complex Using the orthosis elastic band. In this way, the degree of gradual increase of the dorsiflexion angle is recorded on the relevant forms by participants or their parents at night when the orthosis is worn. A hole is placed under the hindfoot to determine the full connection between the heel and the orthosis plate. Therefore, we can be ensured the complete connection of the heel in orthosis and the placement of the subtalar joint in the neutral position. Intervention 2: Control group: The participants will be instructed to do calf muscles eccentric stretching program for 12 weeks which included five sessions per week with each session containing three stretches performed for five sets of 30 seconds at their maximum tolerance level of stretch. To perform the calf muscles eccentric stretching program, from an upright body position and standing on one leg on the edge of the step and next to the wall (Where the subject can restore balance by hand if needed), all body weight will be placed on the forefoot and the ankle joint gone to plantar flexion, the calf muscle will be loaded by having the participant lower the heel beneath the forefoot toward the ankle plantar flexion position. 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 more information
public Dr.saeed forghany
Hezarjarib
isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 31 3792 5028 saeed_forghany@yahoo.co.uk Esfahan University of Medical Sciences scientific Dr. saeed forghany
Hezarjarib
Isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 31 3792 5028 saeed_forghany@yahoo.co.uk Esfahan University of Medical Sciences Iran (Islamic Republic of) Aged 7 to 14 years Have symptomatic flexible flatfoot and gastro-soleus stiffness Normal BMI base on sex and age Pain parameter score of at least 1 7 years 14 years Both Any problems or trauma to the lower extremities Previous Achilles tendon surgery Abnormal ankle bony prominence Inflammatory and / or infectious arthritis Any internal or metabolic disorders Neurological and musculoskeletal problems lower limb length discrepancy Use of any foot orthoses and the calf muscles stretching Any injury or pathology of the foot, knee, hip and/or back M21.40 Flat foot [pes planus] (acquired), unspecified foot Rehabilitation Rehabilitation Intervention group: Night orthoses are made of similar 5 mm polypropylene in two pieces, hinged ankle joint, with an extension in the popliteal area and without a joint for the knee, So, the knee will be straight at night and the gastrocnemius muscle will be stretched effectively by dorsiflexion of the ankle joint. The hinge ankle joint of the orthosis is adjusted at the angle of the maximum amount of tolerable dorsiflexion for each subject (that it does not cause pain or discomfort). A goniometer is placed on the ankle joint to measure the dorsiflexion angle. The ankle is placed at the maximum tolerable dorsiflexion angle for maximum stretching on the gastro-soleus complex Using the orthosis elastic band. In this way, the degree of gradual increase of the dorsiflexion angle is recorded on the relevant forms by participants or their parents at night when the orthosis is worn. A hole is placed under the hindfoot to determine the full connection between the heel and the orthosis plate. Therefore, we can be ensured the complete connection of the heel in orthosis and the placement of the subtalar joint in the neutral position. Control group: The participants will be instructed to do calf muscles eccentric stretching program for 12 weeks which included five sessions per week with each session containing three stretches performed for five sets of 30 seconds at their maximum tolerance level of stretch. To perform the calf muscles eccentric stretching program, from an upright body position and standing on one leg on the edge of the step and next to the wall (Where the subject can restore balance by hand if needed), all body weight will be placed on the forefoot and the ankle joint gone to plantar flexion, the calf muscle will be loaded by having the participant lower the heel beneath the forefoot toward the ankle plantar flexion position. Change of the ankle passive dorsiflexion range of motion. Timepoint: at the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Biodex iskinetics and goniometer. Gastrosoleus muscle stiffness. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Biodex iskinetics. Gait Kinematic. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: motion analysis. Pain. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Wong-Baker FACES scale. Quality of Life. Timepoint: At the beginning of the study, three months later and finally two weeks after the second measurement. Method of measurement: Pediatric Quality of Life Inventory. Esfahan University of Medical Sciences Approved 2021-05-08 Ethics committee of Isfahan University of Medical Sciences Mir Bagheri dormitory, Isfahan University dormitories,Hezarjarib St. Isfahan Isfehan Iran (Islamic Republic of)