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Balance-Cognitive-Strength Training for Balance, Inhibitory Control, and Gait in Preschool Children (BCS-Preschool)

1. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

65

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
      • Beijing, China, 100061
        • China Institute of Sport Science

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Balance-Cognitive-Strength Training
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.
Andere Namen:
  • Exercise-Cognitive Integrated Training
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Single-Task Gait Index at Week 8
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in MABC-2 Total Test Standard Score at Week 8
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aiyoudong Children and Youth Sports Health Research Institute

Mitarbeiter

China institute of sport science

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2024

Primärer Abschluss (Tatsächlich)

25. Februar 2025

Studienabschluss (Tatsächlich)

25. Februar 2025

Studienanmeldedaten

Zuerst eingereicht

1. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juli 2026

Zuerst gepostet (Tatsächlich)

8. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • CISS-20231110-BCS

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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