The training effect of concentrative coordination exercise on academic-related motor functions of children with ADHD

ISRCTN	ISRCTN97661818
DOI	https://doi.org/10.1186/ISRCTN97661818
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	I-Shou 1227
Sponsor	I-Shou University
Funder	Ministry of Science and Technology, Taiwan

Submission date: 16/01/2021
Registration date: 04/02/2021
Last edited: 01/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a condition that includes symptoms such as inattentiveness, hyperactivity and impulsiveness. The aim of this study is to assess the effect of an intervention program to improve concentration, executive functions and handwriting performance in children with ADHD.

Who can participate?
Children with ADHD

What does the study involve?
Children will be recruited and randomly allocated to either on-site table tennis, a table tennis exergame), or a control group. The table tennis training is provided either by a coach or a ball-projection machine in the on-site group. In the exergaming table tennis group the intervention is Nintendo Wii Sport providing coordination exercise to train the concentration of the children with ADHD. The control group receives their regular treatment for the symptoms of ADHD. The intervention lasts 12 weeks with three 1-hour sessions per week.

What are the possible benefits and risks of participating?
The possible benefits of participants are the improvement of concentration level, executive functions, and handwriting. There are very few minor risks such as fatigue or soreness after exercise training.

Where is the study run from?
I-Shou University (Taiwan)

When is the study starting and how long is it expected to run for?
August 2015 to October 2017

Who is funding the study?
Ministry of Science and Technology (Taiwan)

Who is the main contact?
Prof. Nan-Ying Yu
ying@isu.edu.tw

Contact information

Prof Nan-Ying Yu
Scientific

No.8, Yida Rd.
Jiaosu Village Yanchao District
Kaohsiung City
82445
Taiwan

Phone	+886 (0)939268195
Email	ying@isu.edu.tw

Study information

Primary study design	Interventional
Study design	Single-centre randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The training effect of concentrative coordination exercise on the executive function and upper limb motor control of children with ADHD
Study objectives	Concentrative coordination training can improve executive function and handwriting performance in children with ADHD.
Ethics approval(s)	Approved 17/01/2014, Institutional Review Board of the E-DA Hospital (No.6, Yida Road, Jiaosu Village, Yanchao District, Kaohsiung City 82445, Taiwan, R.O.C., +886 (0)7 6150011 ext. 5110; ed107339@edah.org.tw), ref: EMRP60102N
Health condition(s) or problem(s) studied	Attention deficit hyperactivity disorder (ADHD)
Intervention	Children will be recruited and randomly assigned (using randomizer.org) to on-site table tennis (n=20), a table tennis exergame (n=20), or a control group (n=20). The table tennis training is provided either by a coach or a ball-projection machine in the on-site group. In the exergaming table tennis group the intervention is Nintendo Wii Sport providing coordination exercise to train the concentration of the children with ADHD. The control group receives their regular treatment for the symptoms of ADHD. The intervention lasts 12 weeks with three 1-hour sessions per week.
Intervention type	Behavioural
Primary outcome measure(s)	Handwriting performance measured using a self-developed computer program for automation level and response time at baseline and 12 weeks
Key secondary outcome measure(s)	Executive functions measured using the Stroop test and Wisconsin Card Sorting Test (WCST) at baseline and 12 weeks
Completion date	31/10/2017

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	60
Total final enrolment	60
Key inclusion criteria	1. Meet the criteria of DSM-V for ADHD 2. Handwriting deficits confirmed by the administration of the Chinese Handwriting Evaluation Form (CHEF). According to the test manual, the cut-off criterion for the identification of handwriting deficit was two or more of the six dimensions with a median larger than, or equal to, 3
Key exclusion criteria	1. A history of any medical, neurological, or pervasive developmental disorders, intellectual disability, oncological, musculoskeletal, sensory (hearing, vision), or skin disorders 2. Children with IQ score <80 3. Taking any medication other than methylphenidate
Date of first enrolment	10/10/2015
Date of final enrolment	30/05/2016

Locations

Countries of recruitment

Taiwan

Study participating centre

I-Shou University

No.8, Yida Rd.
Jiaosu Village Yanchao District
Kaohsiung
82445
Taiwan

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The participant-level data will be available upon request from Dr Nan-Ying Yu (ying@isu.edu.tw). The data will be available for 2 years and can be provided to researchers who engage in ADHD-related researches upon request for further correlation analyses among the measured variables.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file			01/03/2021	No	No

Additional files

ISRCTN97661818_PROTOCOL.pdf: Uploaded 01/03/2021

Editorial Notes

01/03/2021: Uploaded protocol (not peer reviewed).
04/02/2021: Trial's existence confirmed by the Institutional Review Board of the E-DA Hospital.