The Effect of Adding standard Core Stability Exercises to Standard Sensorimotor Training on Balance Indices and Quality of Life in Children with Autism Spectrum Disorder: A Clinical Trial”
The aim of this study is to investigate the effect of adding core stability exercises to standard sensorimotor exercises on balance and quality of life in children with Autism Spectrum Disorder (ASD). In addition, this study will compare the outcomes between the intervention and control groups to evaluate the effects of the intervention on static balance, dynamic balance, and quality of life in children with ASD.
Design
This is a randomized, controlled, parallel-group clinical trial involving 34 children with Autism Spectrum Disorder (ASD). Participants will be recruited through convenience sampling and randomly allocated (1:1) to the intervention or control group using computer-generated block randomization. This is a non-pharmacological rehabilitation trial
Settings and conduct
This is a randomized controlled trial in children with Autism Spectrum Disorder (ASD). The intervention group will receive core stability plus standard sensorimotor exercises for 8 weeks, while the control group will receive standard sensorimotor exercises only. Balance and quality of life will be assessed before and after the intervention. Open-label study
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children aged 8–12 years with Autism Spectrum Disorder (ASD) and written parental consent.
Exclusion Criteria: More than two absences, medical contraindications, or withdrawal from the study.
Intervention groups
Participants in the intervention group will receive standard sensorimotor exercises in addition to a standard core stability exercise program for 8 weeks, 3 sessions per week, with each session lasting 35–40 minutes. The exercise program will be conducted under the supervision of the researcher or a trained therapist according to a standardized protocol.
Main outcome variables
Static balance; dynamic balance; quality of life in children with Autism Spectrum Disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260622069918N1
Registration date:2026-07-07, 1405/04/16
Registration timing:prospective
Last update:2026-07-07, 1405/04/16
Update count:0
Registration date
2026-07-07, 1405/04/16
Registrant information
Name
Shamim Fadakar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 1826
Email address
shamimefdakar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2026-08-06, 1405/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Adding standard Core Stability Exercises to Standard Sensorimotor Training on Balance Indices and Quality of Life in Children with Autism Spectrum Disorder: A Clinical Trial”
Public title
The Effect of Sensorimotor and Core Stability Exercises on Balance and Quality of Life in Children with Autism Spectrum Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
confirmed diagnosis of Autism Spectrum Disorder (ASD) by a child and adolescent psychiatrist or a pediatric neurologist based on DSM-5 diagnostic criteria.
Ability to understand simple instructions
Ability to participate in the exercise program
Ability to walk independently without the use of assistive devices.
No participation in a structured core stability exercise program during the previous 3 months
No participation in a structured sensorimotor exercise program during the previous 3 months.
Written informed consent provided by a parent or legal guardian.
Exclusion criteria:
Age younger than 8 years or older than 12 years
No confirmed diagnosis of Autism Spectrum Disorder (ASD) based on DSM-5 criteria
Presence of neurological, musculoskeletal, cardiovascular, or other medical conditions that would preclude safe participation in the exercise program.
Inability to walk independently without assistive devices.
Inability to understand or follow simple instructions.
Failure to obtain written informed consent from a parent or legal guardian.
Age
From 8 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate participants to the study groups, block randomization will be employed. This method will be used to ensure a balanced distribution of participants between the study groups throughout the recruitment process and to minimize selection bias and the influence of potential confounding variables.
First, each eligible child with Autism Spectrum Disorder (ASD) who meets the inclusion criteria will be assigned a unique identification code. Subsequently, the randomization process will be performed using a web-based randomization program, and participants will be randomly allocated to one of the two study groups.
Given the total sample size of 30 participants, the participants will be organized into five blocks of six participants each. Within each block, three participants will be assigned to the intervention group and three participants to the control group according to a computer-generated random allocation sequence.
At the completion of the randomization process, two groups of 15 participants each will be formed. The intervention group will receive a combined core stability and sensorimotor training program, whereas the control group will receive sensorimotor training only. The use of block randomization will ensure balanced group sizes and minimize the risk of allocation bias throughout the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine, Islamic Azad University – Mashhad Medical Sciences Branch, Iran
1. Static balance:Static balance was assessed using the Tandem Stance Test, measured as the duration of maintaining the tandem stance in seconds.2. Dynamic balance:Dynamic balance was assessed using the Tandem Walk Test, Measured based on performance during the tandem walking task.3. Quality of life:Quality of life was assessed using the Pediatric Quality of Life Inventory (PedsQL), Measured by the total questionnaire score.
Timepoint
Measurements will be performed at baseline (prior to the intervention) and immediately after completion of the 8-week intervention.
Method of measurement
Tendom walk,tendom stance,test quality of lif(peal)
Secondary outcomes
empty
Intervention groups
1
Description
Control GroupChildren aged 8–12 years with Autism Spectrum Disorder (ASD) in the control group will participate in a standard sensorimotor exercise program. All training sessions will be conducted face-to-face under the direct supervision of the principal investigator or a corrective exercise specialist. The program consists of sensorimotor exercises designed to improve balance, postural control, motor coordination, and proprioception. The exercises will be performed using standard rehabilitation equipment, including balance pads, balance boards, therapy balls, obstacles, and training cones. The intervention will be delivered for 8 weeks, 3 sessions per week, with each session lasting 45–60 minutes. Exercise intensity and difficulty will be progressively increased according to each child’s functional abilities to ensure safety and optimize training effectiveness.
Category
Treatment - Other
2
Description
Intervention group: Intervention GroupChildren aged 8–12 years with Autism Spectrum Disorder (ASD) in the intervention group will participate in a play-based core stability exercise program in addition to the standard sensorimotor exercise program. All training sessions will be conducted face-to-face under the direct supervision of the principal investigator or a corrective exercise specialist. The intervention consists of play-based exercises designed to strengthen the trunk and pelvic stabilizing muscles and improve postural control, balance, motor coordination, and proprioception. The exercises will be performed using therapy balls, BOSU balls, and balance boards, with activities progressively adapted to each child’s functional abilities. The intervention will be delivered over 8 weeks, with three sessions per week, and each session lasting 45–60 minutes. Exercise intensity and difficulty will be progressively increased throughout the intervention to ensure safety, promote active participation, and maximize the effectiveness of the program.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Navid Zendegi
Full name of responsible person
Elham Mosapor
Street address
Navid Zendegi Autism Center, , Between Edalat 4 and Edalat 6, Ahmadabad, Mashhad, Razavi Khorasan Province, Iran.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information generated from this research will be made freely and openly available to researchers and interested individuals through university databases and reputable scientific publications, at no cost.
When the data will become available and for how long
months after the completion of the research project.
To whom data/document is available
All researchers, clinicians, and specialists.
Under which criteria data/document could be used
To facilitate the advancement of academic research and improve patient care by clinicians, researchers, and specialists.
From where data/document is obtainable
Faculty of Physical Education, University of Tehran
Islamic Azad University, Mashhad Branch
Faculty of Humanities Complex
Ostad Yousefi Street, Mashhad, Iran
What processes are involved for a request to access data/document
Upon publication of the scientific articles, all relevant findings and data that may contribute to the advancement of research and the improvement of therapeutic approaches will be made available to the scientific community