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Completed

NCT Number: NCT07149051

Design of a Sensory Integration Intervention Program

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.

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Key information

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese Center of Exercise Epidemiology

Changchun, Jilin, 130024, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Gamified Sensory Integration Exercise Program

Behavioral

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.

Primary outcomes

  1. Sensory Integration Ability

    Time frame: Month 3

    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.

  2. Speed Test

    Time frame: Month 3

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

  3. Flexibility Test

    Time frame: Month 3

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

  4. Coordination Test

    Time frame: Month 3

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

  5. Balance Test

    Time frame: Month 3

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

  6. Lower-limb strength Test

    Time frame: Month 3

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

Sponsors and collaborators

Lead sponsor

Northeast Normal University

Other

Registry information

Official study title

Design and Implementation of a Gamified Sensory Integration Exercise Intervention

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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