UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055788 |
|---|---|
| Receipt number | R000063244 |
| Scientific Title | Effects of exercise-based games on behavioral and physical outcomes in children with neurodevelopmental disorders |
| Date of disclosure of the study information | 2024/10/10 |
| Last modified on | 2025/12/02 22:38:06 |
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Basic information
Public title
Effects of exercise-based games on behavioral and physical outcomes in children with neurodevelopmental disorders
Acronym
Effects of exercise-based games on behavioral and physical outcomes in children with neurodevelopmental disorders
Scientific Title
Effects of exercise-based games on behavioral and physical outcomes in children with neurodevelopmental disorders
Scientific Title:Acronym
Effects of exercise-based games on behavioral and physical outcomes in children with neurodevelopmental disorders
Region
| Japan |
Condition
Condition
Neurodevelopmental disorders
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring the effects of contactless and wearable-free exercise gaming on behavioral outcomes and physical fitness in children with neurodevelopmental disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral changes after 12 sessions of exercise gaming
Key secondary outcomes
Body Mass Index (BMI), Motor skills
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention: Conducting a 12-session standard exercise program and exercise gaming intervention over a 3- to 6-month period
Interventions/Control_2
Control: Conducting a 12-session standard exercise program will be conducted over a 3- to 6-month period
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with a diagnosis of or suspected of having neurodevelopmental disorders who are receiving care and education at child welfare facilities
Key exclusion criteria
Having severe cognitive or motor impairment
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Murakami |
Organization
Kansai Medical University
Division name
Health Science Center
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka 573-1010, Japan
TEL
072-804-0101
m241106@med.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Murakami |
Organization
Kansai Medical University
Division name
Health Science Center
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka 573-1010, Japan
TEL
072-804-0101
Homepage URL
m241106@med.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Ethical Review Center
Address
2-5-1 Shinmachi, Hirakata, Osaka 573-1010, Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063244
