- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Shandong
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Weifang, Shandong, Chine
- Physical Education Department, Weifang University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Motor Proficiency Score
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognitive Processing and Executive Function Scores
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IAU-PLAY-MOTOR-1404
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
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