Sensory Integration DysfunctionNCT07446530
Research on the Impact of Gamification Movement on Children With Sensory Integration Disorders
A study testing Gamified exercise, Sensory integration training and Regular physical education courses in people with Sensory Integration Dysfunction, run by Northeast Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Sensory Integration Dysfunction
- What is being tested?
- Gamified exercise, Sensory integration training and Regular physical education courses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Individuals with abnormal physical appearance; individuals with severe illnesses; individuals with severe cognitive impairments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial on the Impact of Gamification Movement on the Motor Skills of Children With Sensory Integration Disorders
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.
- Conditions
- Sensory Integration Dysfunction
- Being tested
- Gamified exercise, Sensory integration training, Regular physical education courses
- Keywords
- Gamified sports, Sensory integration dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified exerciseBehavioural
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.
Sensory integration trainingBehavioural
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.
Regular physical education coursesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Gamified exercise | Experimental | Not described Receives: Behavioral: Gamified exercise |
| Sensory Integration Training Group | Active comparator | Not described Receives: Behavioral: Sensory integration training |
| Regular physical education courses | Active comparator | Not described Receives: Behavioral: Regular physical education courses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion25 May 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Integration DysfunctionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
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
- NCT07446530
- Sponsor's protocol ID
- CCEE202603
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Impact of Gamification Movement on the Motor Skills of Children With Sensory Integration Disorders
- ClinicalTrials.gov ID
- NCT07446530
- Acronym / sponsor ID
- CCEE202603
- Conditions
- Sensory Integration Dysfunction
- Keywords
- Gamified sports, Sensory integration dysfunction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Northeast Normal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 3 Mar 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals with abnormal physical appearance; individuals with severe illnesses; individuals with severe cognitive impairments.
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 exerciseStudents 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. | Behavioural | Gamified exercise |
| Sensory integration trainingStudents 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. | Behavioural | Sensory Integration Training Group |
| Regular physical education coursesStudents 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. | Behavioural | Regular physical education courses |
Primary outcome
Sensory integration ability
Time frame: month 3
The sensory integration ability of young children was evaluated by measuring their scores on the sensory integration scale before and after the intervention.
Basic motor skills
Time frame: month 3
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.
physical fitness
Time frame: Three months
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.
Pediatric Balance Scale，PBS
Time frame: Three months
The balance ability of the participants was evaluated by measuring their scores in the balance test before and after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Sensory Mechanisms of Manual Dexterity Recovery After Stroke: a Prospective Cohort Study of Prediction and Cerebral Correlates
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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.
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 exercise, Sensory integration training and Regular physical education courses in people with Sensory Integration Dysfunction, 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 3 Mar 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?
This study is still under way. Results are not available in the source record yet.
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 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 3 Mar 2026.