Protocol summary
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Study aim
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Investigating the effectiveness of physical exercises on balance, cognition, and dual-task performance in 6-12 years old children with Autism Spectrum Disorder
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Design
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Double-blinded Randomized controlled trial of 30 patients; randomization will be via block randomization.
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Settings and conduct
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After receiving the code of ethics, students of the centers and schools of Tehran City will be screened to check the inclusion criteria and eligible children; After obtaining written consent from the parents, they will undergo initial evaluation and be randomly divided into two experimental and control groups. Before the implementation of the intervention, children's balance, cognitive and dual-task performance are measured by a co-evaluator who does not know which group the participants belong to. The intervention group received a 24-session occupational therapy program, and the control group received routine interventions. After completing the occupational therapy program, the variables will be re-evaluated
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include diagnosis of high-functioning autism; obtaining a score of 55-70 in the GARS-3 questionnaire; age 6-12 years old. Exclusion criteria: using aids such as canes to maintain balance; or take medications that affect balance.
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Intervention groups
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Participants in the intervention group will participate in a 24-session 45-minute occupational therapy program. This program includes several categories of physical activities to improve agility, balance, central stability, and motor coordination. In this program, with the increase in the number of treatment sessions, the difficulty level of the exercises will increase.
Participants in the control group receive routine rehabilitation interventions.
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Main outcome variables
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Balance; cognition; the ability to do cognitive-motor dual-tasks
General information
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Reason for update
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Due to the insufficient number of samples and the lack of access to some assessment tools in Shiraz city, the location of the study was changed to Tehran city.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221214056817N1
Registration date:
2023-05-12, 1402/02/22
Registration timing:
prospective
Last update:
2024-02-26, 1402/12/07
Update count:
1
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Registration date
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2023-05-12, 1402/02/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-05-15, 1402/02/25
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Expected recruitment end date
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2023-11-16, 1402/08/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Investigating the effectiveness of physical activities on motor and cognitive skills in children with autism
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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.
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Age
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From 6 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-12-04, 1401/09/13
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1401.567
Health conditions studied
1
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Description of health condition studied
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Autism Spectrum Disorder
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ICD-10 code
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F84.0
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ICD-10 code description
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Autistic disorder
Primary outcomes
1
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Description
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Static and dynamic balance
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Timepoint
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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.
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Method of measurement
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Using the Walking Heel to Toe test to evaluate dynamic balance and using the Force Plate device to assess static balance.
2
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Description
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Cognitive functions
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Timepoint
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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.
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Method of measurement
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Wisconsin card sorting tests, forward and backward digit span test, and executive function behavioral rating questionnaires will be used to evaluate cognitive indicators.
3
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Description
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Ability to perform dual tasks
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Timepoint
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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.
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: receive routine rehabilitation program.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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information on the primary and secondary outcome measures
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When the data will become available and for how long
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After publishing the articles
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To whom data/document is available
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Researchers in this field
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Under which criteria data/document could be used
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1. Written permissions from the research team
2. Mention the source of information
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From where data/document is obtainable
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Mina Hashempour Alooche
E-mail: minhashempour@gmail.com
address:Rehabilitation Science School Of Shahid Beheshti University of Medical Sciences, Damavand Ave., Imam Hossein Square, Tehran
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What processes are involved for a request to access data/document
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After sending the email to the researcher and requesting the document, the researcher will obtain the opinion of other members of the research team regarding the provision of this information and, if the members agree, the documents will be sent as soon as possible but sending the documents requires the acceptance of the criteria mentioned above.
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Comments
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