Motor DevelopmentBCS-PreschoolNCT07689474
Balance-Cognitive-Strength Training for Balance, Inhibitory Control, and Gait in Preschool Children
A study testing Balance-Cognitive-Strength Training in people with Motor Development and Balance, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Development, Balance, Healthy Children
- What is being tested?
- Balance-Cognitive-Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 25 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Motor Development, Balance, Healthy Children, Gait, Executive Function
- Being tested
- Balance-Cognitive-Strength Training
- Keywords
- preschool children, balance ability, gait performance, dual task, inhibitory control, exercise-cognitive intervention, balance-cognitive-strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance-Cognitive-Strength TrainingBehavioural
Also called Exercise-Cognitive Integrated 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.
| Study group | Role | What they receive |
|---|---|---|
| Balance-Cognitive-Strength Training | Experimental | 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. Receives: Behavioral: Balance-Cognitive-Strength Training |
| Usual Daily Activities | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Single-Task Gait Index at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in Dual-Task Gait Index at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in Balance Composite Score at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in Inhibitory Control Composite Score at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Secondary outcomes (10)
Change From Baseline in MABC-2 Total Test Standard Score at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in MABC-2 Manual Dexterity Component Score at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in MABC-2 Aiming and Catching Component Score at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in MABC-2 Balance Component Score at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in 10-Meter Shuttle Run Time at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in Standing Long Jump Distance at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in Tennis Ball Throw Distance at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in Double-Foot Continuous Jump Time at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in Sit-and-Reach Distance at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Change From Baseline in Balance Beam Walking Time at Week 8
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.
Measured: Baseline and immediately after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Oct 2024
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: an 8-week balance-cognitive-strength training group or a usual daily activity control group.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- China Institute of Sport Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689474
- Sponsor's protocol ID
- CISS-20231110-BCS
- Acronym
- BCS-Preschool
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Balance Ability and Gait Performance in Preschool Children: The Mediating Role of Inhibitory Control and Verification Through an Exercise-Cognitive Intervention
- ClinicalTrials.gov ID
- NCT07689474
- Acronym / sponsor ID
- BCS-Preschool / CISS-20231110-BCS
- Conditions
- Motor Development, Balance, Healthy Children, Gait, Executive Function
- Keywords
- preschool children, balance ability, gait performance, dual task, inhibitory control, exercise-cognitive intervention, balance-cognitive-strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Aiyoudong Children and Youth Sports Health Research InstituteUniversity, hospital or other
- Collaborators
- China Institute of Sport Science
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: an 8-week balance-cognitive-strength training group or a usual daily activity control group.
| Arm | Type | Receives |
|---|---|---|
| Balance-Cognitive-Strength Training | Experimental | Behavioral: Balance-Cognitive-Strength TrainingParticipants 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. |
| Usual Daily Activities | No intervention | –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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance-Cognitive-Strength TrainingAlso: Exercise-Cognitive Integrated TrainingThe 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. | Behavioural | Balance-Cognitive-Strength Training |
Primary outcome
Change From Baseline in Single-Task Gait Index at Week 8
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
Change From Baseline in MABC-2 Total Test Standard Score at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in MABC-2 Manual Dexterity Component Score at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in MABC-2 Aiming and Catching Component Score at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in MABC-2 Balance Component Score at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in 10-Meter Shuttle Run Time at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in Standing Long Jump Distance at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in Tennis Ball Throw Distance at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in Double-Foot Continuous Jump Time at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in Sit-and-Reach Distance at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Change From Baseline in Balance Beam Walking Time at Week 8
Time frame: Baseline and immediately after the 8-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance-Cognitive-Strength Training in people with Motor Development and Balance, run by Aiyoudong Children and Youth Sports Health Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Single-Task Gait Index at Week 8 (time frame: Baseline and immediately after the 8-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.