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Trial registered on ANZCTR


Registration number
ACTRN12622000477729
Ethics application status
Approved
Date submitted
11/02/2022
Date registered
25/03/2022
Date last updated
28/02/2023
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of “Square Stepping Exercise” on motor and cognitive skills in Autism Spectrum Disorders children and adolescents
Scientific title
Effects of “Square Stepping Exercise” on motor and cognitive skills in Autism Spectrum Disorders children and adolescents
Secondary ID [1] 306122 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorders 324794 0
Condition category
Condition code
Mental Health 322245 322245 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group: Participants will receive Square-Stepping Exercise (SSE) intervention, twice a week, for 9 weeks. The instructors will receive initial training on Autism Spectrum Disorder (ASD) (characteristics, strengths, motivation, and disruptive behaviour management techniques) and will be familiarized with the participants before starting the intervention. The training sessions will last approximately 30 minutes. The first activity will be a general warm-up consisting of mobility and balistic exercises of lower limbs muscles; then the participants will proceed to learn and execute the walking patterns selected for that day, and they all should be repeated 5 times on a mat especifically designed for SSE. The instructor will mark every attempt providing information about if it was correctly performed, performed with aids or with mistakes. The session will finish with a cool-down consisting of stretching of the main muscles of lower and upper limbs and trunk. All session will be drived by a professional of sports sciences and physical activity. Sessions will be delivered in group of no more than 10 children. The exercise will be only practiced during training sessions and under the supervision of instructors. At the end of each session, participants will be asked for their subjective perceived exertion though a Borg scale adapted to 10 ítems formulary. Adherence to intervention will be monitor by the instructors prior to start each session. All instructors know the SSE exercise and have experience teaching them in different populations with typical development and different diseases.
Intervention code [1] 322531 0
Treatment: Other
Comparator / control treatment
Control group: Participants will continue with their usual care or treatments and will only participate in the assessments.
Control group
Active

Outcomes
Primary outcome [1] 330440 0
Movement Assessment Battery for Children 2 (MACB-2): This battery consists of a standardized test composed of eight tests which assess three dimensions of movement, with different tests divided into three age ranges (3-6, 7-10 and 11-16 years). Psychometric properties are adequate, with reliability values above .70 on all scales, and consistent validity when differentiating children with and without motor dysfunctions. The Balance section will be used for this study, which assesses static and dynamic balance through different tests for the different age ranges.
Timepoint [1] 330440 0
At the beginning of the program (week 1), at the end of the program (week 10, primary timepoint), and a follow-up after one month following the end of the training sessions (week 14).
Primary outcome [2] 330628 0
The Behavioural Observation Checklist (MACB-2): This checklist included in the MACB-2 allows the observation of specific motor skills that occur in everyday en-vironments. It can be used for children between 5 and 12 years of age and is composed of three sections: Section A is entitled "Moving in a static and/or predictable environment." It consists of 15 items and is scored on a Likert scale from 0 to 3, where 0 means "very well" and 3 means "with great difficulty". There is a response option for unob-served behaviors. Section B, "Moving in a dynamic and/or unpredictable environment", is composed of 15 items and is scored the same as section A. Section C, "Non-motor factors that may affect movement", consists of 13 dichotomous responses items (yes or no).
Timepoint [2] 330628 0
At the beginning of the program (week 1), at the end of the program (week 10, primary timepoint), and a follow-up after one month following the end of the training sessions (week 14).
Secondary outcome [1] 406224 0
Sensory Profile 2, Short form (SP2): This questionnaire evaluates sensory processing by providing information on different sensory patterns (seeking, avoiding, sensitivity and registration), through the sensory systems (auditory, visual, tactile, and oral processing), obtaining information about adaptive behaviours (socioemotional and attention) in children between 3 years and 14 years and 11 months. The Spanish version consists of three versions: children, scholar, and a brief version. Their reliability values are above .70 on all their factors and versions. In this study, the children's version will be used.
Timepoint [1] 406224 0
At the beginning of the program (week 1), at the end of the program (week 10), and a follow-up after one month following the end of the training sessions (week 14).
Secondary outcome [2] 406225 0
Test on Perception of Differences (FACES) in its Spanish version assesses perceptual and attentional skills using 60 graphic items consist-ing of schematic drawings of faces with elementary strokes. It consists of choosing which of the three faces that make up each element is different from the other two. It is a very brief test (three minutes) that can be ap-plied to children and adolescents between 6 and 18 years.
Timepoint [2] 406225 0
At the beginning of the program (week 1), at the end of the program (week 10), and a follow-up after one month following the end of the training sessions (week 14).
Secondary outcome [3] 406226 0
Short Version of the Executive Functioning Questionnaire (EFECO-S), composed of 20 items into five factors: emotional self-control, initiative and planning, working memory, inhibition and organization that allow screening for difficulties in daily executive functioning. It can be completed by both parents and relatives and is valid for children and adolescents between 6 and 13 years of age.
Timepoint [3] 406226 0
At the beginning of the program (week 1), at the end of the program (week 10), and a follow-up after one month following the end of the training sessions (week 14).
Secondary outcome [4] 406227 0
Rings and Interference tests from the Neuropsychological Assessment of Executive Functions in Children (ENFEN). The ring test consists of the reproduction, on a board with three vertical axes of a model pre-sented on a sheet (towers task); while the interference test consists of a list of 39 words representing coloured names (red, green, yellow, and blue) but printed in ink of a different colour. The task consists of telling the colour of the word ink, inhibiting the written word (Stroop paradigm). Its results are validated for use in children and adolescents between 6 and 12 years of age. This is a composite outcome.
Timepoint [4] 406227 0
At the beginning of the program (week 1), at the end of the program (week 10), and a follow-up after one month following the end of the training sessions (week 14).

Eligibility
Key inclusion criteria
Participants will meet with: a) age between 6 and 16 years; b) have a clinical ASD diagnosis under The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; c) be able to understand and follow simple commands; d) not suffer any inconvenience that prevents physical activity; e) children and adolescents’ voluntariness to take part in the study; and e) to provide signed informed consent form by the legal guardians.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Participants will be randomly assigned to experimental (SSE) or control group (usual care) using The Research Randomizer (http://www.randomizer.org), using a computer-generated randomization sequence (1:1). A member of the team not in-volved in this trial will handle this task, protecting the assignment in a password-protected computer file.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Statistical Package for the Social Sciences (SPSS, Version 25, IBM SPSS, Ar-monk, NY, USA) software will be used to perform the analyses.
Data normality and homogeneity will be assessed with Kolmogorov-Smirnov and Levene’s test. Descriptive data will be expressed as mean and standard deviation (SD) (normal-distributed variables) or median and interquartile range (non-normal distrib-uted variables). Then, data will be analysed by intention-to-treat and protocol.
Intention-to-treat analysis. All randomised participants will be considered for the analysis in its group. Missing data will be imputed through multiple imputations. Repeated measures analyses of covariance adjusted by age and baseline outcomes will be used to analyse the intervention effects on the different dependent variables. The effect size (95% confidence interval) and differences will be calculated in every varia-ble concerning time and group × time interaction. The alpha level will be set at p < 0.05. The data imputation for sensitivity analyses will be carried out on individuals who present data at baseline and at the end of the trial, to prevent estimation bias.
Analysis by protocol. The analyses previously described will be carried out, but only with participants who have attended at least 80% of the program sessions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
1/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 24571 0
Spain
State/province [1] 24571 0
Cáceres

Funding & Sponsors
Funding source category [1] 310470 0
University
Name [1] 310470 0
University of Extremadura
Country [1] 310470 0
Spain
Primary sponsor type
University
Name
Universidad de Extremadura
Address
Av. de Elvas, s/n, 06006 Badajoz
Country
Spain
Secondary sponsor category [1] 311993 0
None
Name [1] 311993 0
Address [1] 311993 0
Country [1] 311993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310101 0
Bioethics and Biosafety Committee at the University of Extremadura
Ethics committee address [1] 310101 0
Ethics committee country [1] 310101 0
Spain
Date submitted for ethics approval [1] 310101 0
09/12/2021
Approval date [1] 310101 0
15/12/2021
Ethics approval number [1] 310101 0
162/2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116474 0
Dr Sabina Barrios-Fernández
Address 116474 0
Department of Terapéutica Médico-Quirúgica, Faculty of Nursing and Occupational Therapy, University of Extremadura, Av. de la Universidad, s/n, 10003 Cáceres
Country 116474 0
Spain
Phone 116474 0
+34 927 257460
Fax 116474 0
Email 116474 0
sabinabarrios@unex.es
Contact person for public queries
Name 116475 0
Sabina Barrios-Fernández
Address 116475 0
Department of Terapéutica Médico-Quirúgica, Faculty of Nursing and Occupational Therapy, University of Extremadura, Av. de la Universidad, s/n, 10003 Cáceres
Country 116475 0
Spain
Phone 116475 0
+34 927 257460
Fax 116475 0
Email 116475 0
sabinabarrios@unex.es
Contact person for scientific queries
Name 116476 0
Sabina Barrios-Fernández
Address 116476 0
Department of Terapéutica Médico-Quirúgica, Faculty of Nursing and Occupational Therapy, University of Extremadura, Av. de la Universidad, s/n, 10003 Cáceres
Country 116476 0
Spain
Phone 116476 0
+34 927 257460
Fax 116476 0
Email 116476 0
sabinabarrios@unex.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.