Balance-Cognitive-Strength Training for Balance, Inhibitory Control, and Gait in Preschool Children (BCS-Preschool)
1 luglio 2026 aggiornato da: Aiyoudong Children and Youth Sports Health Research Institute
Relationship Between Balance Ability and Gait Performance in Preschool Children: The Mediating Role of Inhibitory Control and Verification Through an Exercise-Cognitive Intervention
This randomized controlled study evaluated whether an 8-week balance-cognitive-strength training program improved balance ability, inhibitory control, and gait performance in preschool children aged 3 to 6 years.
Children completed balance tests, single-task walking tests, dual-task walking tests, and an iPad-based Go/No-Go task before and after the intervention.
The intervention group received exercise-cognitive integrated training 3 times per week for 8 weeks, and the control group maintained usual daily activities.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
Preschool children aged 3 to 6 years were recruited from a kindergarten in Weifang, China. Eligible children completed baseline assessments of balance ability, gait performance, and inhibitory control. Balance was assessed using static and dynamic balance tasks on a Zebris force platform. Gait was assessed during single-task walking and dual-task walking while counting backward. Inhibitory control was assessed using an iPad-based Go/No-Go task.
Participants were randomly assigned to a balance-cognitive-strength training group or a usual daily activity control group. The training group received an 8-week exercise-cognitive integrated training program, 3 sessions per week and 40 minutes per session. Training activities included balance exercises, lower-limb strength activities, brisk walking games, and embedded cognitive tasks such as counting, verbal naming, memory tasks, and response inhibition tasks. The control group maintained usual daily activities during the same period.
Outcomes were assessed at baseline and immediately after the 8-week intervention.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
65
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Beijing, Cina, 100061
- China Institute of Sport Science
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- Children aged 3 to 6 years.
- Children enrolled in the participating kindergarten in Weifang, China.
- Children able to understand and follow simple instructions for motor, gait, balance, and cognitive testing.
- Children able to participate in regular physical activity and complete the 8-week intervention or usual activity period.
- Written informed consent provided by a parent or legal guardian.
Exclusion Criteria:
- Diagnosed neurological, developmental, or motor disorder.
- Serious cardiovascular, respiratory, musculoskeletal, or other medical condition that would limit safe participation in physical activity.
- Lower-limb injury, deformity, or disease affecting standing, walking, balance, or jumping.
- Visual or hearing impairment that would prevent completion of the study tasks.
- Inability to complete the baseline assessments or comply with study procedures.
- Participation in another structured motor or cognitive intervention during the study period.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Balance-Cognitive-Strength Training
Participants received an 8-week exercise-cognitive integrated training program, 3 sessions per week and 40 minutes per session.
The program combined balance exercises, lower-limb strength activities, brisk walking or aerobic walking games, and embedded cognitive tasks involving counting, verbal naming, working memory, and response inhibition.
|
The intervention was an 8-week exercise-cognitive integrated training program for preschool children.
Sessions were conducted 3 times per week, 40 minutes per session, at moderate intensity.
The program combined balance exercises, lower-limb strength activities, brisk walking or aerobic walking games, and embedded cognitive tasks involving counting, verbal naming, working memory, and response inhibition.
Altri nomi:
|
|
Nessun intervento: Usual Daily Activities
Participants maintained their usual kindergarten and daily physical activities during the same 8-week period and did not receive the structured balance-cognitive-strength training program.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Single-Task Gait Index at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
The Single-Task Gait Index was derived from gait variables measured during normal walking.
Gait was assessed using a gait analysis system during single-task walking.
Variables included stance time, stride time, double-support time, step width variability, loading rate, and related temporal-spatial gait parameters.
Variables were standardized and direction-unified before construction of the gait index.
Higher scores indicate better single-task gait performance.
The change score was calculated as the post-intervention score minus the baseline score.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in Dual-Task Gait Index at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
The Dual-Task Gait Index was derived from gait variables measured while children walked and performed a concurrent cognitive task.
During dual-task walking, participants walked while counting backward from 10 to 1. Variables included stance time, stride time, double-support time, step width variability, loading rate, and related temporal-spatial gait parameters.
Variables were standardized and direction-unified before construction of the gait index.
Higher scores indicate better gait performance under cognitive load.
The change score was calculated as the post-intervention score minus the baseline score.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in Balance Composite Score at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Balance ability was assessed using static and dynamic balance tasks on a Zebris force platform.
The Balance Composite Score was constructed from standardized balance variables using principal component analysis.
The composite score reflected anterior-posterior sway control, load symmetry, and dynamic postural adjustment.
Negative indicators, such as center-of-pressure velocity and ellipse area, were direction-unified before score calculation.
Higher scores indicate better overall balance ability.
The change score was calculated as the post-intervention score minus the baseline score.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in Inhibitory Control Composite Score at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Inhibitory control was assessed using an iPad-based Go/No-Go task from the Early Years Toolbox.
Children were instructed to respond to Go stimuli and inhibit responses to No-Go stimuli.
Accuracy and reaction time were standardized and direction-unified to create an inhibitory control composite score.
Higher scores indicate better inhibitory control.
The change score was calculated as the post-intervention score minus the baseline score.
|
Baseline and immediately after the 8-week intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in MABC-2 Total Test Standard Score at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Motor development was assessed using the Movement Assessment Battery for Children, Second Edition (MABC-2), age band 1 for children aged 3 to 6 years.
The total test standard score was derived from the manual dexterity, aiming and catching, and balance components.
Higher standard scores indicate better motor development.
The change score was calculated as the post-intervention score minus the baseline score.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in MABC-2 Manual Dexterity Component Score at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Manual dexterity was assessed using the MABC-2 age band 1 manual dexterity tasks, including fine motor tasks such as posting coins, threading beads, and drawing trail.
Scores were converted according to the MABC-2 scoring manual.
Higher component scores indicate better manual dexterity.
The change score was calculated as the post-intervention score minus the baseline score.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in MABC-2 Aiming and Catching Component Score at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Aiming and catching ability was assessed using the MABC-2 age band 1 aiming and catching tasks, including catching and throwing tasks.
Scores were converted according to the MABC-2 scoring manual.
Higher component scores indicate better ball skill and object-control performance.
The change score was calculated as the post-intervention score minus the baseline score.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in MABC-2 Balance Component Score at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Motor balance was assessed using the MABC-2 age band 1 balance tasks, including static and dynamic balance tasks such as one-leg balance, walking with heels raised, and jumping tasks.
Scores were converted according to the MABC-2 scoring manual.
Higher component scores indicate better balance-related motor development.
The change score was calculated as the post-intervention score minus the baseline score.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in 10-Meter Shuttle Run Time at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Agility and movement speed were assessed using the 10-meter shuttle run from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in seconds.
Lower values indicate better performance.
The change score was calculated as the post-intervention time minus the baseline time.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in Standing Long Jump Distance at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Lower-limb explosive strength was assessed using the standing long jump from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in centimeters.
Higher values indicate better performance.
The change score was calculated as the post-intervention distance minus the baseline distance.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in Tennis Ball Throw Distance at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Upper-limb power and object-control ability were assessed using the tennis ball throw from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in meters or centimeters according to the test record form.
Higher values indicate better performance.
The change score was calculated as the post-intervention distance minus the baseline distance.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in Double-Foot Continuous Jump Time at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Coordination and lower-limb jumping ability were assessed using the double-foot continuous jump test from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in seconds.
Lower values indicate better performance.
The change score was calculated as the post-intervention time minus the baseline time.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in Sit-and-Reach Distance at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Flexibility was assessed using the sit-and-reach test from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in centimeters.
Higher values indicate better flexibility.
The change score was calculated as the post-intervention distance minus the baseline distance.
|
Baseline and immediately after the 8-week intervention
|
|
Change From Baseline in Balance Beam Walking Time at Week 8
Lasso di tempo: Baseline and immediately after the 8-week intervention
|
Dynamic balance was assessed using the balance beam walking test from the Chinese national physical fitness test battery for children aged 3 to 6 years.
The outcome was recorded in seconds.
Lower values indicate better performance.
The change score was calculated as the post-intervention time minus the baseline time.
|
Baseline and immediately after the 8-week intervention
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 ottobre 2024
Completamento primario (Effettivo)
25 febbraio 2025
Completamento dello studio (Effettivo)
25 febbraio 2025
Date di iscrizione allo studio
Primo inviato
1 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 luglio 2026
Primo Inserito (Effettivo)
8 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CISS-20231110-BCS
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data will not be shared because the study involved preschool children and the informed consent and ethics approval did not include public sharing of individual-level participant data.
Summary results will be reported in publications and on ClinicalTrials.gov
as required.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Funzione esecutiva
-
Paul SzabolcsReclutamentoMalattia granulomatosa cronica | Sindrome di DiGeorge | Disregolazione immunitaria | Immunodeficienza variabile comune (CVID) | Sindrome di Omen | Carenza di ligando CD40 | Suscettibilità mendeliana alla malattia micobatterica | Disturbo primario della regolazione immunitaria | STAT 1 Gain of Function | STAT... e altre condizioniStati Uniti