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IRCT20221214056817N1 IRCT 2023-05-12 Shahid Beheshti University of Medical Sciences Investigating the effectiveness of physical activities on motor and cognitive skills in children with autism Investigating the Effectiveness of Physical Activities on Balance, Cognition, and Performing Dual Tasks among Children with Autism Spectrum Disorder: A Double-Blind Randomized Clinical Trial 2023-05-15 anticipated 30 Complete https://irct.ir/trial/67445 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Children aged 6-12 with high-functioning autism were included in the study using accessible sampling. Then the stratified randomization method will be used, and the samples will be classified based on age and body mass index. The stratified randomization method eliminates the need to control the influence of background variables. In this method, we create a separate block for each combination of contextual variables, and subjects are assigned to a suitable block of contextual variables. After all the subjects have been identified and divided into blocks, they are placed in groups that have equal sample size through the block randomization method, and considering all possible balanced combinations of assignment in the block and random selection of one of these situations are assigned to one of the experimental or control groups through a lottery for each block of people, Blinding description: In this study, each person is assigned a number, and they are randomly placed in the experimental or control groups, then the researcher performs the therapeutic intervention on the group without knowing about their attribution; The evaluator is also another colleague who is also unaware of how people are allocated; data evaluation will also be done by someone other than the research team. N/A Autism Spectrum Disorder. Intervention 1: Intervention group: The intervention group will participate in a 45-minute exercise program. This program includes several categories of physical exercises to improve agility, balance, central stability, and motor coordination. Among the different parts of this program, we can mention jumping, walking on different surfaces, balancing activities in various positions, exercises aimed at improving central stability and bilateral coordination, eye-hand coordination, and eye-foot coordination. In this program, with the increase in the number of therapy sessions, the exercises' difficulty level will increase. It is worth noting that the intervention is conducted by an occupational therapist with experience working with children with an autism spectrum disorder in the form of 45-minute individual sessions three times a week for eight weeks. Intervention 2: Control group: receive routine rehabilitation program. 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 It is not yet known
public Ali Asghar Jamebozorgi
Rehabilitation Science School Of Shahid Beheshti University of Medical Sciences, Damavand Ave., Imam Hossein Square
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 aas.bozorg@yahoo.com Shahid Beheshti University of Medical Sciences scientific Ali Asghar Jamebozorgi
Rehabilitation Science School Of Shahid Beheshti University of Medical Sciences, Damavand Ave., Imam Hossein Square
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 aas.bozorg@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Child psychiatrists diagnose high-functioning Autism Spectrum Disorder Using the Gilliam Autism Rating Scale - Third Edition (GARS 3) to diagnose level 1 Autism Spectrum Disorder The students study in normal schools or special autism spectrum disorders schools Participants are between the ages of 6 and 12 6 years 12 years Both Maintaining balance or walking with aids Using balance-affecting drugs Being visually and audibly impaired Having comorbidities of autism spectrum disorders with psychological disorders such as attention deficit hyperactivity disorder, obsessive compulsive disorder, etc. F84.0 Autistic disorder Rehabilitation N/A Intervention group: The intervention group will participate in a 45-minute exercise program. This program includes several categories of physical exercises to improve agility, balance, central stability, and motor coordination. Among the different parts of this program, we can mention jumping, walking on different surfaces, balancing activities in various positions, exercises aimed at improving central stability and bilateral coordination, eye-hand coordination, and eye-foot coordination. In this program, with the increase in the number of therapy sessions, the exercises' difficulty level will increase. It is worth noting that the intervention is conducted by an occupational therapist with experience working with children with an autism spectrum disorder in the form of 45-minute individual sessions three times a week for eight weeks. Control group: receive routine rehabilitation program. Static and dynamic balance. Timepoint: Measurement of a static and dynamic balance of the samples before the start of the intervention and eight weeks after the beginning of the intervention in the test group. Method of measurement: Using the Walking Heel to Toe test to evaluate dynamic balance and using the Force Plate device to assess static balance. Cognitive functions. Timepoint: Measuring the cognitive functions of the samples before the start of the intervention and eight weeks after the beginning of the intervention in the test group. Method of measurement: Wisconsin card sorting tests, forward and backward digit span test, and executive function behavioral rating questionnaires will be used to evaluate cognitive indicators. Ability to perform dual tasks. Timepoint: Measuring the ability to perform dual tasks of the samples before the start of the intervention and eight weeks after the beginning of the intervention in the test group. Method of measurement: The person performs balance tests, including the Walking Heel Toe Test and standing on the Force Plate device simultaneously with the Forward Digit Span Test. Shahid Beheshti University of Medical Sciences Approved 2022-12-04 Research Ethics Committee of Shahid Beheshti University of Medical Sciences Building No. 2, Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjou Blvd., Valenjak Tehran Tehran Iran (Islamic Republic of)