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 |
| Secondary identifying numbers | I-Shou 1227 |
- 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
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
Scientific
No.8, Yida Rd.
Jiaosu Village Yanchao District
Kaohsiung City
82445
Taiwan
| Phone | +886 (0)939268195 |
|---|---|
| ying@isu.edu.tw |
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 | Handwriting performance measured using a self-developed computer program for automation level and response time at baseline and 12 weeks |
| Secondary outcome measures | Executive functions measured using the Stroop test and Wisconsin Card Sorting Test (WCST) at baseline and 12 weeks |
| Overall study start date | 01/08/2015 |
| Completion date | 31/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 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
Jiaosu Village Yanchao District
Kaohsiung
82445
Taiwan
Sponsor information
University/education
No.8, Yida Rd
Jiaosu Village Yanchao District
Kaohsiung City
82445
Taiwan
| Phone | +886 (0)76151100 |
|---|---|
| misservice@most.gov.tw | |
| Website | http://www.isu.edu.tw/en1/ |
"ROR" |
https://ror.org/04d7e4m76 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
- Location
- Taiwan
Results and Publications
| Intention to publish date | 05/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| 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? |
|---|---|---|---|---|---|
| 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.
