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Trial registered on ANZCTR


Registration number
ACTRN12623000742673
Ethics application status
Approved
Date submitted
31/05/2023
Date registered
10/07/2023
Date last updated
6/07/2024
Date data sharing statement initially provided
10/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical, Cognitive and Behavioral Outcomes, and Physical Activity Interventions in Children with Neurodevelopmental Disorders and Typical Developing Children
Scientific title
Physical, Cognitive and Behavioral Outcomes, and Physical Activity Interventions in Children with Neurodevelopmental Disorders and Typical Developing Children
Secondary ID [1] 309800 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical outcomes 330210 0
Cognitive outcomes 330211 0
Behavioral outcomes 330212 0
Condition category
Condition code
Public Health 327078 327078 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 80 children (at least 20 children in each group), aged 4-12 years, will be recruited to participate in the study. All children with Neurodevelopmental Disorders (i.e., attention deficit hyperactivity disorder [ADHD] and autism spectrum disorder [ASD]) will be matched by age and ability, and then randomly selected to participate in either a 3-month (80 minutes per day, two days a week for 12 weeks) motor skill intervention, a 3-month yoga intervention, or a 3-month taewondo intervention. A group of typically development children will receive no intervention and serve as a control.

Motor skill intervention
a) The performance criteria of each skill in the TGMD-3 Examiner’s Manual will be used. The skills that will be taught including balance, running, underhand rolling and throwing, galloping and leaping, sliding, jumping and hopping, stationary dribbling/bouncing, overhand throwing, catching, hopping, kicking, and striking a stationary ball.
b) Each session comprised six activities, namely warm-up (10 min), review of previously learned skills (15 min), instruction and practice of a new skill [Level I (15 min)], progression of a new skill [Level II (15 min)], progression of a new skill [Level III (15 min)], and cool-down (10 min).
c) All sessions will be run by the primary investigator with assistance from trained research assistants.
d) The intervention will be run 2 days/week, 80 min/day, for a total of 32 hr of direct instruction over the 12-week intervention.
e) The intervention will be consisted of 24 sessions (each lasting 80 min) that will be conducted twice a week over 12 weeks of the 2023–24 school year.
f) All intervention sessions will be conducted in a gymnasium in a large and public urban university in South Taiwan.
g) Each session will be concluded with an opportunity to play with kids’ favorite activities as a reward.

Yoga intervention
a) Twelve structured yoga modules will be developed for this study based on the International Kids Yoga Alliance.
b) The structured yoga modules followed a sequence of five components: (a) chanting (10 min), (b) preparatory practices (20 min), (c) yoga postures or asanas (20 min), (d) breathing practices including breathing exercises and pranayama (20 min), and (e) relaxation (10 min).
c) All sessions will be run by the yoga teacher with assistance from the primary investigator. The yoga teacher will have relevant teaching experience with children with disabilities.
d) The intervention will be run 2 days/week, 80 min/day, for a total of 32 hr of direct instruction over the 12-week intervention.
e) The intervention will be consisted of 24 sessions (each lasting 80 min) that will be conducted twice a week over 12 weeks of the 2023–24 school year.
f) All intervention sessions will be conducted in a gymnasium in a large and public urban university in South Taiwan.
g) Each session will be concluded with an opportunity to play with kids’ favorite activities as a reward.

Taewondo intervention
a) The Taewondo training protocol that suits the participants’ motor abilities will be produced by a skilled Taewondo instructor.
b) The Taewondo intervention program consisted of 10 min of warm-up, 30 min of block, punching, and kicking, 30 min of Poomse, and 10 min of cool-down.
c) All sessions will be run by qualified Taewondo instructor with assistance from the primary investigator. The Taewondo instructor will have relevant teaching experience with children with disabilities.
d) The intervention will be run 2 days/week, 80 min/day, for a total of 32 hr of direct instruction over the 12-week intervention.
e) The intervention will be consisted of 24 sessions (each lasting 80 min) that will be conducted twice a week over 12 weeks of the 2023–24 school year.
f) All intervention sessions will be conducted in a gymnasium in a large and public urban university in South Taiwan.
g) Each session will be concluded with an opportunity to play with kids’ favorite activities as a reward.
Intervention code [1] 326229 0
Behaviour
Comparator / control treatment
Approximately 20 typically development (TD) children will participated in the study. While children with neurodevelopmental disorders will receive the physical activity interventions (i.e., motor skill intervention, yoga intervention, and taewondo intervention), the TD children will receive no intervention and serve as a control group.
Control group
Active

Outcomes
Primary outcome [1] 334945 0
Physical outcomes (i.e., Test of Gross Motor Development-3)
Timepoint [1] 334945 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs (T2), and a third time after another 12 weeks (T3).
Primary outcome [2] 334946 0
Cognitive outcomes (i.e., Stroop Color and Word Test)
Timepoint [2] 334946 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs (T2), and a third time after another 12 weeks (T3).
Primary outcome [3] 335212 0
Physical outcomes (i.e., Bruininks-Oserestsky Test of Motor Proficiency-2)
Timepoint [3] 335212 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs (T2), and a third time after another 12 weeks (T3).
Secondary outcome [1] 422503 0
Adaptive Behavior Assessment System-2
Timepoint [1] 422503 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs (T2), and a third time after another 12 weeks (T3).
Secondary outcome [2] 423475 0
Cognitive outcomes (i.e., Wisconsin Card Sorting Test)
Timepoint [2] 423475 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs (T2), and a third time after another 12 weeks (T3).
Secondary outcome [3] 423476 0
Cognitive outcomes (i.e., Stockings of Cambridge)
Timepoint [3] 423476 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs (T2), and a third time after another 12 weeks (T3).
Secondary outcome [4] 423477 0
Cognitive outcomes (i.e., Spatial Working Memory)
Timepoint [4] 423477 0
Each participant will be assessed three times, once at study entry (T1), a second time after 12 weeks of intervention programs (T2), and a third time after another 12 weeks (T3).

Eligibility
Key inclusion criteria
The inclusion criteria for the participants with ASD and ADHD will be as follows: (1) current age between 4 and 12 years, (2) a diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria, (3) a diagnosis of ADHD based on DSM-V criteria, (4) the ability to follow directions and perform requested motor skill proficiency and executive function measures, and (5) no history of reading disabilities according to parents. The inclusion criteria for the control group of participants will be as follows: (1) current age between 4 and 12 years, and (2) the parentally provided history will not show any evidence of hyperactive or impulsive behavior, ADHD, and reading disabilities.
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children diagnosed with intellectual disability and cerebral palsy will be excluded.

Study design
Purpose of the study
Educational / counselling / training
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 randomisation using procedures like coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Data will be analyzed using mixed model two-way analyses of variance and paired t-tests. Alpha level will be set at p < .01.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
4/09/2023
Date of last participant enrolment
Anticipated
31/12/2023
Actual
31/12/2023
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 25568 0
Taiwan, Province Of China
State/province [1] 25568 0
Kaohsiung

Funding & Sponsors
Funding source category [1] 313983 0
Government body
Name [1] 313983 0
National Science and Technology Council
Country [1] 313983 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
National Science and Technology Council
Address
106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 315865 0
University
Name [1] 315865 0
National Kaohsiung Normal University
Address [1] 315865 0
No.116, He-Ping First Road, Kaohsiung, Taiwan, R.O.C.
Country [1] 315865 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313120 0
NCKU HREC-F-112-071-2
Ethics committee address [1] 313120 0
Ethics committee country [1] 313120 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 313120 0
Approval date [1] 313120 0
07/04/2023
Ethics approval number [1] 313120 0

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

Contacts
Principal investigator
Name 127066 0
Prof Chien-Yu Pan
Address 127066 0
National Kaohsiung Normal University, No.116, He-Ping First Road, Taiwan, R.O.C.
Country 127066 0
Taiwan, Province Of China
Phone 127066 0
+88677172930
Fax 127066 0
Email 127066 0
chpan@mail.nknu.edu.tw
Contact person for public queries
Name 127067 0
Chien-Yu Pan
Address 127067 0
National Kaohsiung Normal University, No.116, He-Ping First Road, Kaohsiung, Taiwan, R. O. C.
Country 127067 0
Taiwan, Province Of China
Phone 127067 0
+88677172930
Fax 127067 0
Email 127067 0
chpan@mail.nknu.edu.tw
Contact person for scientific queries
Name 127068 0
Chien-Yu Pan
Address 127068 0
National Kaohsiung Normal University, No.116, He-Ping First Road, Kaohsiung, Taiwan, R. O. C.
Country 127068 0
Taiwan, Province Of China
Phone 127068 0
+88677172930
Fax 127068 0
Email 127068 0
chpan@mail.nknu.edu.tw

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.