Sensory Integration DisorderNCT07149051
Design of a Sensory Integration Intervention Program
A study testing Gamified Sensory Integration Exercise Program in people with Sensory Integration Disorder, run by Northeast Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 7 years
- Conditions the study is for
- Sensory Integration Disorder
- What is being tested?
- Gamified Sensory Integration Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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 6 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design and Implementation of a Gamified Sensory Integration Exercise Intervention
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.
- Conditions
- Sensory Integration Disorder
- Being tested
- Gamified Sensory Integration Exercise Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Sensory Integration Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Gamified Sensory Integration Exercise Program |
| Control Group | No intervention | Participants in the control group received the regular physical education curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 3
Speed Test
was measured using the 50 m sprint. Assessments were conducted at baseline and at three months.
Measured: Month 3
Flexibility Test
Flexibility was measured using the sit-and-reach test. Assessments were conducted at baseline and at three months.
Measured: Month 3
Coordination Test
Coordination was measured using the one-minute rope skipping test. Assessments were conducted at baseline and at three months.
Measured: Month 3
Balance Test
Balance was measured using the single-leg stance with eyes closed. Assessments were conducted at baseline and at three months.
Measured: 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Mar 2023
- Primary completion10 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Integration DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeast Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Yang, Prof. Dr., Northeast Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149051
- Sponsor's protocol ID
- CCEE2055
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Implementation of a Gamified Sensory Integration Exercise Intervention
- ClinicalTrials.gov ID
- NCT07149051
- Acronym / sponsor ID
- CCEE2055
- Conditions
- Sensory Integration Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northeast Normal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Aug 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Gamified Sensory Integration Exercise ProgramThe intervention program consists of gamified physical activities, incorporating game elements such as game scenarios, mechanisms, and components into the teaching content. |
| Control Group | No intervention | –Participants in the control group received the regular physical education curriculum. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Gamified Sensory Integration Exercise ProgramThis 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. | Behavioural | Intervention Group |
Primary outcome
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.
Speed Test
Time frame: Month 3
was measured using the 50 m sprint. Assessments were conducted at baseline and at three months.
Flexibility Test
Time frame: Month 3
Flexibility was measured using the sit-and-reach test. Assessments were conducted at baseline and at three months.
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.
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.
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.
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 29 Aug 2025.
- Individual participant dataSharing planned: No
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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 Gamified Sensory Integration Exercise Program in people with Sensory Integration Disorder, run by Northeast Normal University 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 3 inclusion and 3 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 29 Aug 2025. 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?
Sensory Integration Ability (time frame: Month 3). The study lists 6 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 29 Aug 2025.