Relationship Between Balance Ability and Gait Performance in Preschool Children: The Mediating Role of Inhibitory Control and Verification Through an Exercise-Cognitive Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change From Baseline in Single-Task Gait Index at Week 8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking was used because participants and trainers were aware of group assignment.
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change From Baseline in Single-Task Gait Index at Week 8
时间窗: 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.
Change From Baseline in Dual-Task Gait Index at Week 8
时间窗: 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.
Change From Baseline in Balance Composite Score at Week 8
时间窗: 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.
Change From Baseline in Inhibitory Control Composite Score at Week 8
时间窗: 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.
次要结局
- Change From Baseline in MABC-2 Total Test Standard Score at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in MABC-2 Manual Dexterity Component Score at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in MABC-2 Aiming and Catching Component Score at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in MABC-2 Balance Component Score at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in 10-Meter Shuttle Run Time at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in Standing Long Jump Distance at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in Tennis Ball Throw Distance at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in Double-Foot Continuous Jump Time at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in Sit-and-Reach Distance at Week 8(Baseline and immediately after the 8-week intervention)
- Change From Baseline in Balance Beam Walking Time at Week 8(Baseline and immediately after the 8-week intervention)