Balance-Cognitive-Strength Training for Balance, Inhibitory Control, and Gait in Preschool Children (BCS-Preschool)
1. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
65
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Beijing, Čína, 100061
- China Institute of Sport Science
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
Ostatní jména:
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline in Single-Task Gait Index at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Dual-Task Gait Index at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Balance Composite Score at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Inhibitory Control Composite Score at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline in MABC-2 Total Test Standard Score at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in MABC-2 Manual Dexterity Component Score at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in MABC-2 Aiming and Catching Component Score at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in MABC-2 Balance Component Score at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in 10-Meter Shuttle Run Time at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Standing Long Jump Distance at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Tennis Ball Throw Distance at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Double-Foot Continuous Jump Time at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Sit-and-Reach Distance at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Change From Baseline in Balance Beam Walking Time at Week 8
Časové okno: Baseline and immediately after the 8-week intervention
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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.
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Baseline and immediately after the 8-week intervention
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. října 2024
Primární dokončení (Aktuální)
25. února 2025
Dokončení studie (Aktuální)
25. února 2025
Termíny zápisu do studia
První předloženo
1. července 2026
První předloženo, které splnilo kritéria kontroly kvality
1. července 2026
První zveřejněno (Aktuální)
8. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- CISS-20231110-BCS
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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