NCT07149051

Brief Summary

This study aims to explore the mechanisms of motor skill promotion and sensory integration intervention for first-grade primary school students with sensory integration dysfunction. By designing a gamified exercise intervention program tailored to lower-grade students, and combining it with the assessment and analysis of sensory integration functions, the study seeks to systematically improve their sensory integration ability and physical fitness, thereby supporting healthy growth and enhanced adaptability during this critical stage of physical and psychological development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 18, 2025

Last Update Submit

August 26, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Sensory Integration Ability

    Sensory integration ability was measured using the Participants' Sensory Integration Development Evaluation Scale. The scale consists of 58 items rated on a five-point Likert scale and covers vestibular function, tactile defensiveness, proprioception, learning ability, and special problems; the last dimension was excluded due to the participants' age. Assessments were conducted at baseline and at three months.

    Month 3

  • Speed Test

    was measured using the 50 m sprint. Assessments were conducted at baseline and at three months.

    Month 3

  • Flexibility Test

    Flexibility was measured using the sit-and-reach test. Assessments were conducted at baseline and at three months.

    Month 3

  • Coordination Test

    Coordination was measured using the one-minute rope skipping test. Assessments were conducted at baseline and at three months.

    Month 3

  • Balance Test

    Balance was measured using the single-leg stance with eyes closed. Assessments were conducted at baseline and at three months.

    Month 3

  • Lower-limb strength Test

    Lower-limb strength was measured using the standing long jump. Assessments were conducted at baseline and at three months.

    Month 3

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention program consists of gamified physical activities, incorporating game elements such as game scenarios, mechanisms, and components into the teaching content.

Behavioral: Gamified Sensory Integration Exercise Program

Control Group

NO INTERVENTION

Participants in the control group received the regular physical education curriculum.

Interventions

This study implemented a gamified physical activity intervention aimed at improving sensory integration abilities among first-grade students with sensory processing difficulties. The intervention program incorporated game narratives, mechanisms, and components into physical education activities, guided by the Octalysis Framework to strategically engage both extrinsic (e.g., rewards, rankings) and intrinsic (e.g., creativity, social interaction, meaning) motivational drives.

Intervention Group

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 6 and 7 years;
  • Diagnosis of sensory integration dysfunction in at least one subscale of the assessment tool;
  • Informed consent was obtained from both legal guardians and teachers.

You may not qualify if:

  • Physical deformities or other conditions limiting participation in physical activities;
  • Serious medical conditions;
  • Severe cognitive impairments that could interfere with comprehension or participation in the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Center of Exercise Epidemiology

Changchun, Jilin, 130024, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 29, 2025

Study Start

March 1, 2023

Primary Completion

June 10, 2023

Study Completion

June 30, 2023

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations