NCT07045922

Brief Summary

This RCT design investigates the effects of an 8-week motor-cognitive training program on cognitive performance and balance in preschool-aged children. Participants in the intervention group received structured motor-cognitive activities twice a week in addition to their regular physical education (PE) classes. The control group attended only standard PE classes and was restricted from participating in any other physical activity. Assessments included cognitive testing (Go/No-Go, Tower of Hanoi, and Corsi Block), anthropometric measurements, and static/proprioceptive balance testing. All measurements were conducted pre- and post-intervention.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 1, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 23, 2025

Last Update Submit

November 23, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cognitive Function Tests

    Evaluates inhibitory control, a core component of executive functioning. Participants are required to respond quickly to target stimuli (e.g., "X") while inhibiting responses to non-target stimuli (e.g., "O"). Measures include: Number of correct responses (go trials) Number of commission errors (false responses to no-go trials) Reaction time (latency) to correct go stimuli Duration: \~5 minutes and 40 seconds

    Administered at baseline (pre-intervention) and 8 weeks (post-intervention)

  • Tower of Hanoi Test executive functioning

    Assesses executive functioning, including planning, problem-solving, and cognitive flexibility. Participants solve a visual puzzle by moving disks across pegs, following specific rules. Performance variables include: * Number of moves to solution * Total task completion time * Average time per move * Latency to first move (planning time)

    Baseline and 8 weeks

  • Balance Performance

    Balance was assessed using the Sensbalance MiniBoard, a validated interactive platform that captures both static and proprioceptive balance. Two types of balance tasks were used: Static Balance Test: Participants were instructed to maintain a stable position on the balance board while keeping a ball centered within a visual target zone on the screen. The performance level (%) was calculated using the formula: (1 - Measured Sway Amplitude / Maximum Allowable Sway) × 100, indicating the participant's ability to maintain balance within defined limits.

    Baseline and 8 weeks

Study Arms (2)

Motor-Cognitive Training Program

EXPERIMENTAL

• Motor-Cognitive Training Program: Game-based physical activities targeting cognitive and motor domains (e.g., running drills, hand skills, stability tasks). Exercises progressed weekly in complexity and duration. Sessions lasted 25-30 minutes, twice weekly.

Behavioral: Motor-Cognitive Training ProgramOther: Regular Physical education classes

Regular Physical education

OTHER

• Regular PE classes only; no additional physical or motor training permitted.

Other: Regular Physical education classes

Interventions

Participants assigned to the intervention group participated in a structured motor-cognitive training program in addition to their regular physical education (PE) classes. The training was designed to integrate physical movement with cognitive engagement in a game-based format, suitable for the preschool age group. The program was conducted twice weekly for eight weeks, with each session lasting approximately 25-30 minutes. Activities progressed in complexity over time, incorporating elements of motor planning, executive functioning, and balance control. Sessions consisted of: Warm-up phase: Light aerobic activities such as jogging, dynamic stretching, and coordination drills (e.g., knee pulls, toe walking). Main training phase: Activities targeting core cognitive-motor domains l

Motor-Cognitive Training Program

Participants in the control group continued with their regularly scheduled physical education (PE) classes as mandated by the school curriculum. They did not receive any additional motor-cognitive or structured exercise training. Furthermore, they were instructed not to engage in any external physical activity programs outside of the regular PE sessions throughout the study duration. This restriction was monitored to ensure group consistency.

Motor-Cognitive Training ProgramRegular Physical education

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Typically developing preschool-aged children
  • Able to follow basic instructions
  • Parental/guardian consent obtained

You may not qualify if:

  • Diagnosed neurodevelopmental disorders
  • Recent musculoskeletal injuries
  • Participation in other structured physical activity programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdağ Namik Kemal University

Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ataxia

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 1, 2025

Study Start

June 30, 2025

Primary Completion

November 30, 2025

Study Completion

December 1, 2025

Last Updated

December 1, 2025

Record last verified: 2025-06

Locations