- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07929012
Play-Based Motor Programme and Child Development Outcomes in Pre-Adolescent Boys (PLAY-MOTOR-BOY)
Play-Based Motor Intervention Improves Motor Proficiency, Cognitive Processing, and Executive Functioning in Pre-Adolescent Boys: A Randomised Controlled Trial With Sub-Scale Profiling
The goal of this clinical trial is to learn if an 8-week play-based motor programme helps improve motor skills, thinking skills, and executive functioning in pre-adolescent boys (ages 10 to 12). The main questions it aims to answer are:
- Does the programme improve motor skills (such as balance, catching, and hand dexterity)?
- Does the programme improve thinking skills and executive functioning (such as memory and self-control)?
Researchers will compare boys who take part in the programme to boys who do standard physical education to see if the programme works.
Participants will:
- Take part in a play-based motor programme 3 times a week for 8 weeks. Each session lasts 60 minutes.
- Be assigned to one of the two groups by chance (like flipping a coin).
- Complete motor and thinking tests at the start and end of the study. Parents will also fill out a questionnaire about their child's behavior.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This is a parallel-group, randomized controlled trial (RCT) following CONSORT 2010 reporting guidelines. The study evaluates whether an 8-week play-based motor programme can improve motor proficiency, cognitive processing, and executive functioning (EF) in pre-adolescent boys.
Participants and Randomization: A total of 80 boys aged 10-12 years (Grades 4-6) from two single-sex primary schools will be recruited. Students will be block-randomized (block size 4) to the intervention group or the control group in a 1:1 ratio. Allocation will be generated using a computer-based sequence. The primary outcome is motor proficiency, with cognitive processing and EF as secondary outcomes.
Intervention: The intervention group will receive an 8-week play-based motor programme delivered by trained physical education teachers three times per week (60 min per session; 24 sessions in total). Each session includes a 10-min warm-up (dynamic stretching and locomotor games), a 40-min main activity phase (animal-imitation locomotion, ball-skill circuits, and cooperative balance challenges), and a 10-min cool-down. The control group will continue their regular physical education curriculum with no additional motor programming.
Outcome Measures: Motor proficiency will be assessed using the Movement Assessment Battery for Children-2 (MABC-2). Cognitive processing will be measured using the Kay Cognitive-Diagnostic Test. Executive functioning will be indexed using the parent-report Behavior Rating Inventory of Executive Function (BRIEF). All instruments will be administered at pre-test (Week 0) and post-test (Week 9).
Statistical Analysis Plan: All analyses will be conducted in IBM SPSS Statistics version 25. A one-way multivariate analysis of covariance (MANCOVA) will be used, with pre-test scores as covariates, to examine the simultaneous multivariate group effect. Follow-up separate one-way ANCOVAs, each controlling for the respective pre-test score, will be conducted for all outcome variables. Effect sizes will be reported as partial eta-squared (ηp²).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Shandong
-
Weifang, Shandong, Kina
- Physical Education Department, Weifang University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 1. Male sex. 2. Age 10-12 years. 3. Enrolled in a single-sex primary school. 4. Absence of neurological, orthopedic, or developmental disorder precluding participation.
5. Parental written consent.
Exclusion Criteria:
- 1. Chronic illness requiring regular medication. 2. Prior involvement in a motor training programme within six months. 3. Incomplete baseline assessments.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Play-Based Motor Programme
Participants receive an 8-week play-based motor programme (3 times per week, 60 min/session). Sessions include a 10-min warm-up, a 40-min main activity phase with motor-enriched games (animal-imitation locomotion, ball-skill circuits, cooperative balance challenges), and a 10-min cool-down. Progressive overload is achieved by increasing task complexity and reducing external support. |
An 8-week play-based motor programme delivered three times per week (24 sessions in total, 60 min per session). Focuses on motor-enriched games including animal-imitation locomotion, ball-skill circuits, and cooperative balance challenges. |
|
Aktiv komparator: Standard Physical Education
Participants continue their regular physical education curriculum with no additional motor programming. |
The standard physical education curriculum delivered in schools, without additional motor programming. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Motor Proficiency Score
Tidsramme: Baseline (Week 0) and Post-Intervention (Week 9)
|
Motor proficiency is assessed with the Movement Assessment Battery for Children-2 (MABC-2) Age Band 2. It yields three component scores (Manual Dexterity, Aiming & Catching, Balance) and a Total Standard Score. Higher scores indicate better motor proficiency. |
Baseline (Week 0) and Post-Intervention (Week 9)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive Processing and Executive Function Scores
Tidsramme: Baseline (Week 0) and Post-Intervention (Week 9)
|
Cognitive processing is measured with the Kay Cognitive-Diagnostic Test (Concept Formation, Symbolic Thinking, Socialization of Thought, Attention/Psychomotor Speed). Executive functioning is indexed by the parent-report Behavior Rating Inventory of Executive Function (BRIEF), yielding eight subscales and three composite indices (BRI, MI, GEC). For the BRIEF, lower scores indicate better EF. |
Baseline (Week 0) and Post-Intervention (Week 9)
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IAU-PLAY-MOTOR-1404
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Anonymized participant data supporting the conclusions of this article will be deposited in an open repository (OSF/Zenodo) upon acceptance. Pre-acceptance data-sharing requests may be directed to the corresponding author.
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