Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000593538
Ethics application status
Approved
Date submitted
15/03/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of an in-line skating program in students with high functioning autism spectrum disorder and attention deficit hyperactivity disorder
Scientific title
Effects of an in-line skating program on motor, cognitive and behavioural skills in students with high functioning autism spectrum disorder and attention deficit hyperactivity disorder
Secondary ID [1] 311750 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism spectrum disorder 333242 0
Attention deficit hyperactivity disorder 333245 0
Condition category
Condition code
Public Health 329934 329934 0 0
Health promotion/education
Mental Health 330198 330198 0 0
Autistic spectrum disorders
Mental Health 330199 330199 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 80 children (autism spectrum disorder [ASD], n = 40; attention deficit hyperactivity disorder [ADHD], n = 40), aged 6-12 years, were recruited to participate in the study. Participants were matched by age and sex within each disability group, and then randomly assigned to an inline skating experimental group (ASD Group One, n = 20; ADHD Group One, n = 20) or a wait-list control group (ASD Group Two, n = 20; ADHD Group Two, n = 20). Group One received the in-line skating program in the first phase of 12 weeks (80 minutes per day, two days a week), followed by the second assessment and a return to baseline physical activity for the second phase of 12 weeks. Group Two participants received the intervention during the second 12-week phase and maintained baseline physical activity during the first phase. Each training session included 15 minutes of warm-up, 60 minutes of motor skill and cardiovascular training, and 5 minutes of cooldown. Examples of basic inline skating skills included: marching in a standing position, properly falling and getting up, two-foot forward gliding, marching while moving, forward swizzling, backward acceleration drills, forward parallel turning, forward snowplow stopping, half swizzle pumps in a circle, and left and right forward balance turning. The national inline skating coach taught each session, and the primary investigator supervised all the sessions. The ratio of research assistants to study participants varied from 1:2 to 1:1, depending on the attendance of students on each day. This inline skating intervention program was conducted on the multipurpose ball court in the University where the primary investigator worked. Session attendance checklists were used to monitor adherence to the intervention. No physical or informational materials were provided.
Intervention code [1] 328206 0
Behaviour
Intervention code [2] 328391 0
Lifestyle
Comparator / control treatment
A group of typically development children (TDC, n = 40) was received no intervention and serve as a control.
Control group
Active

Outcomes
Primary outcome [1] 337694 0
Motor development
Timepoint [1] 337694 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Primary outcome [2] 337695 0
Motor proficiency
Timepoint [2] 337695 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Primary outcome [3] 337696 0
Cognitive interference
Timepoint [3] 337696 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [1] 432895 0
Spatial working memory (the outcome is primary)
Timepoint [1] 432895 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [2] 433844 0
Spatial planning (the outcome is primary)
Timepoint [2] 433844 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [3] 433845 0
Cognitive flexibility (the outcome is primary)
Timepoint [3] 433845 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [4] 433846 0
Aerobic assessment (the outcome is primary)
Timepoint [4] 433846 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [5] 433847 0
Abdominal muscular strength and endurance assessment (the outcome is primary); this will be assessed as a composite outcome
Timepoint [5] 433847 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [6] 433848 0
Flexibility assessment (the outcome is primary)
Timepoint [6] 433848 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [7] 433849 0
Physical activity (the outcome is primary)
Timepoint [7] 433849 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).
Secondary outcome [8] 433850 0
Adaptive behavioural skills
Timepoint [8] 433850 0
Each participant was assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs or second baseline (T2), and a third time after another 12-week (T3).

Eligibility
Key inclusion criteria
The inclusion criteria for the participants with ASD or ADHD were as follows: (1) current age between 6 and 12 years, (2) a diagnosis of ASD based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR), (3) a diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR), and (4) having no additional disabilities or diseases that may interfere with the exercise intervention program, executive function assessments, or motor skill proficiency evaluations.
The inclusion criteria for the control group of participants were as follows: (1) current age between 6 and 12 years, and (2) the parentally provided history did not show any evidence of hyperactive or impulsive behavior, ASD, and ADHD.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children diagnosed with intellectual disability and cerebral palsy were excluded.

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)
Allocation was concealed by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using procedures like coin-tossing. No other procedures were used.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
31/07/2016
Date of last data collection
Anticipated
Actual
31/07/2017
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 26202 0
Taiwan, Province Of China
State/province [1] 26202 0

Funding & Sponsors
Funding source category [1] 316082 0
Government body
Name [1] 316082 0
National Science and Technology Council
Country [1] 316082 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
National Science and Technology Council
Address
Country
Taiwan, Province Of China
Secondary sponsor category [1] 318249 0
University
Name [1] 318249 0
National Kaohsiung Normal University
Address [1] 318249 0
Country [1] 318249 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314903 0
National Changhua University of Education, Research Ethics Committee
Ethics committee address [1] 314903 0
Ethics committee country [1] 314903 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 314903 0
22/04/2014
Approval date [1] 314903 0
27/06/2014
Ethics approval number [1] 314903 0
approval no. 103-085

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

Contacts
Principal investigator
Name 133102 0
Prof Chien-Yu Pan
Address 133102 0
National Kaohsiung Normal University. No.116, He-Ping First Road, Taiwan, R.O.C.
Country 133102 0
Taiwan, Province Of China
Phone 133102 0
+88677172930
Fax 133102 0
Email 133102 0
[email protected]
Contact person for public queries
Name 133103 0
Chien-Yu Pan
Address 133103 0
National Kaohsiung Normal University. No.116, He-Ping First Road, Taiwan, R.O.C.
Country 133103 0
Taiwan, Province Of China
Phone 133103 0
+88677172930
Fax 133103 0
Email 133103 0
[email protected]
Contact person for scientific queries
Name 133104 0
Chien-Yu Pan
Address 133104 0
National Kaohsiung Normal University. No.116, He-Ping First Road, Taiwan, R.O.C.
Country 133104 0
Taiwan, Province Of China
Phone 133104 0
+88677172930
Fax 133104 0
Email 133104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will only be available for individual participants by request.


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.