UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061528 |
|---|---|
| Receipt number | R000070405 |
| Scientific Title | Effects of Movement Development Stage-Based Motor Instruction and Play Environment Creation on Motor Competence in Preschool Children: A Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/05/16 |
| Last modified on | 2026/05/11 20:04:36 |
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Basic information
Public title
Effects of Movement Development Stage-Based Motor Instruction and Play Environment Creation on Motor Competence in Preschool Children: A Non-Randomized Controlled Trial
Acronym
Motor Instruction and Play Environment Study
Scientific Title
Effects of Movement Development Stage-Based Motor Instruction and Play Environment Creation on Motor Competence in Preschool Children: A Non-Randomized Controlled Trial
Scientific Title:Acronym
Motor Instruction and Play Environment Study
Region
| Japan |
Condition
Condition
Low fundamental motor skills in preschool children
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of movement development stage-based motor instruction and play environment creation on motor competence improvement in preschool children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
In this study, T1 is defined as the pre-intervention assessment, T2 as the post-intervention assessment for the intervention group, and T3 as the post-intervention assessment for the control group. Changes in motor performance records (25-m sprint, standing long jump, and tennis ball throw), movement development stages (5-level classification by Nakamura et al., 2011), and Test of Gross Motor Development-Third Edition scores between groups (T1 to T2).
Key secondary outcomes
1) Changes in grip strength between groups (T1 to T2); 2) Motivation and confidence toward physical activity (parental questionnaire); 3) Changes in motor performance records, movement development stages, and Test of Gross Motor Development-Third Edition scores from T2 to T3 in the intervention group (maintenance of intervention effects); 4) Changes in the same outcomes from T2 to T3 in the control group (reproducibility of intervention effects); 5) Dose-response relationship between session attendance rate and changes in motor performance and movement development stages.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Motor instruction based on movement development stages will be provided for sprinting and throwing. Structured movement play designed to improve sprinting and throwing motor patterns in accordance with each child's developmental stage will be implemented, based on the 5-level movement development classification by Nakamura et al. (2011) and the Test of Gross Motor Development, Third Edition. In addition, unstructured play incorporating sprinting and throwing elements will also be conducted. For jumping, play environment creation using diverse everyday materials will be provided. Specifically, circuit play and group play using everyday materials such as newspapers, hoops, rubber bands, and balloons will be implemented. Frequency: 2-3 sessions per week, 40 minutes per session, for 6 weeks.
Interventions/Control_2
During the intervention period of the intervention group (T1 to T2), the control group will continue only the usual childcare program. After the T2 assessment, the same intervention program as the intervention group will be implemented.
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
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Preschool children aged 3 to 6 years whose parents or guardians have provided consent
Key exclusion criteria
Children with orthopedic, neurological, or internal medical conditions that prevent participation in physical activity, and children whose parents or guardians did not provide consent.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yushin |
| Middle name | |
| Last name | Yoshizato |
Organization
Kyushu University of Nursing and Social Welfare
Division name
Department of Rehabilitation
Zip code
865-0062
Address
888 Tomio, Tamana City, Kumamoto Prefecture
TEL
080-6408-9913
y-yoshizato@kyushu-ns.ac.jp
Public contact
Name of contact person
| 1st name | Yushin |
| Middle name | |
| Last name | Yoshizato |
Organization
Kyushu University of Nursing and Social Welfare
Division name
Department of Rehabilitation
Zip code
865-0062
Address
888 Tomio, Tamana City, Kumamoto Prefecture
TEL
080-6408-9913
Homepage URL
y-yoshizato@kyushu-ns.ac.jp
Sponsor or person
Institute
Kyushu University of Nursing and Social Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kyushu University of Nursing and Social Welfare
Address
888 Tomio, Tamana City, Kumamoto Prefecture
Tel
0968-75-1800
office@Kyushu-ns.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
玉名第一保育所（熊本県）、豊水保育所（熊本県）、伊倉保育所（熊本県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 16 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
| 2026 | Year | 10 | Month | 09 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2027 | Year | 02 | Month | 28 | Day |
Other
Other related information
[Covariates] Facility-level covariates (number of outdoor play equipment, site area, number of toys provided, and free play time) and individual-level covariates (birth weight, gestational age, presence of siblings, sleep duration, breakfast consumption, physical activity, screen time, extracurricular activities, primary play location, number of toys owned, ball ownership, parental exercise frequency, and parental self-rated physical fitness) will be collected in advance and incorporated into the analysis model as needed. Covariate selection criteria will be pre-specified in this registration based on between-group differences at baseline.
[Statistical analysis] For motor performance records and Test of Gross Motor Development-Third Edition scores, normality will be assessed and either Linear Mixed Model or non-parametric tests will be applied accordingly. For movement development stages (ordinal scale), ordinal logistic regression will be used as the primary analysis, with Linear Mixed Model as a sensitivity analysis. Significance level: 5%; Software: R (latest stable version).
Management information
Registered date
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070405
