NCT07446530

Brief Summary

This study aims to investigate the impact of gamified exercise intervention on the sensory integration ability and basic motor skills of children with sensory integration dysfunction. A randomized controlled trial design will be adopted, recruiting 48 children with sensory integration dysfunction and randomly assigning them to three groups: the gamified exercise group, the sensory integration training group, and the regular physical education curriculum group.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

January 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 23, 2026

Last Update Submit

February 28, 2026

Conditions

Sensory Integration Dysfunction

Keywords

Gamified sportsSensory integration dysfunction

Outcome Measures

Primary Outcomes (4)

  • Sensory integration ability

    The sensory integration ability of young children was evaluated by measuring their scores on the sensory integration scale before and after the intervention.

    month 3

  • Basic motor skills

    The level of basic motor skills development in young children was evaluated by measuring their performance in completing 13 actions before and after the intervention.

    month 3

  • physical fitness

    By measuring the seven physical indicators of the participants before and after the intervention, including height (in centimeters), 10-meter shuttle run (seconds), standing long jump (centimeters), tennis throw distance (meters), consecutive double jumps (seconds), sit-and-reach test (centimeters), and walking on a balance beam (seconds), their physical health status can be evaluated.

    Three months

  • Pediatric Balance Scale，PBS

    The balance ability of the participants was evaluated by measuring their scores in the balance test before and after the intervention.

    Three months

Study Arms (3)

Gamified exercise

EXPERIMENTAL
Behavioral: Gamified exercise

Sensory Integration Training Group

ACTIVE COMPARATOR
Behavioral: Sensory integration training

Regular physical education courses

ACTIVE COMPARATOR
Behavioral: Regular physical education courses

Interventions

Gamified exerciseBEHAVIORAL

Students in the gamification group will undergo a 12-week gamification exercise program, with interventions conducted three times a week, each lasting 60 minutes. The main components include warm-up, game segment, and cool-down. Participants' attendance and adherence will be recorded during the intervention period.

Gamified exercise
Sensory integration trainingBEHAVIORAL

Students in the sensory integration training group will undergo a 12-week sensory integration training program, with interventions conducted three times a week for 60 minutes each time. The main components include warm-up, sensory integration training, and relaxation. Participants' attendance and compliance will be recorded during the intervention period.

Sensory Integration Training Group
Regular physical education coursesBEHAVIORAL

Students in the regular physical education curriculum group will undergo a 12-week regular physical education program, with interventions conducted three times per week for 60 minutes each time. The main components include warm-up, physical activities, and relaxation. Participants' attendance and adherence will be recorded during the intervention period.

Regular physical education courses

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • According to the Developmental Rating Scale for Sensory Integration Abilities in Children, the subject's score in any of the tests for vestibular sense, proprioception, and tactile sense is less than 40; they are willing to participate in this study; and their guardian has signed the informed consent form.

You may not qualify if:

  • Individuals with abnormal physical appearance; individuals with severe illnesses; individuals with severe cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science

Changchun, Jilin, 130022, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 23, 2026

First Posted

March 3, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

June 20, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

CN(1)