Autistic Spectrum DisorderNCT03957044
the Effect of Vestibular Rehabilitation in Autistic Children
A study testing The education of sensory integration with vestibular education in people with Autistic Spectrum Disorder and Vestibular Disorder, run by Istinye University.
Trial summary
This study was conducted to clarify the effect of vestibular education for autistic children on "sensory profile" and "postrotary nystagmus". In the study, the results of the two groups were compared through the treatment of sensory integration: the once who got the education and the once who did not. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autistic Spectrum Disorder, Vestibular Disorder, Sensory Integration Disorder
- What is being tested?
- The education of sensory integration with vestibular education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 1 Jul 2013
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The study included autistic children aged between 3 and 10 years (36 months, 11 years old) who were diagnosed with autism according to the Diagnostic and Statistical Manual of Mental Disorders criteria. The families of all children who participated in the study were informed and their written permissions were obtained.
Who cannot join
- Children who were not diagnosed with autism and who had previously received treatment for sensory integrity were excluded. The children who participated in the study had independent walking problems, those with lack of extremity, those with hip dislocation, those with postural anomalies, those who had an operation, those with infectious diseases, those with additional diagnoses with autism (such as cerebral palsy), patients with seizures, traumatic postpartum trauma, and motor development disorder. those with the postural disorder were not included in the study
About this study
Official title: The Effect of Vestibular Rehabilitation on Sensory Profile and Postrotary Nystagmus in Autistic Children
This study was conducted to clarify the effect of vestibular education for autistic children on "sensory profile" and "postrotary nystagmus". In the study, the results of the two groups were compared through the treatment of sensory integration: the once who got the education and the once who did not. For this study, 26 autistic children were included who joined the " Çatalca District Unit of Disabled the Project of No Disabilities ", who was diagnosed with autism, who was 3-10 years (older than 36 months younger than 11 years). For each child, the analysis of the sensory integration and nystagmus was applied twice; at the beginning and at the end of the research. At the beginning of the research, the children were divided into two groups randomly drawn by lots. The first group was given the education of sensory integration with vestibular education and the second group was given the education of sensory integration without vestibular education. Both groups were educated for 10 weeks, 2 days a week with 40- minute sessions.
- Being tested
- The education of sensory integration with vestibular education
- Medical subject headings
- Autism Spectrum Disorder, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The education of sensory integration with vestibular educationOther
Tactical, proprioceptive, visual and auditory senses were used in sensory integrity training sessions. In this group, the training program on tactile, proprioceptive, visual and auditory sensory activities was carried out for 2 weeks and 40 minutes. Sensory integrity training was performed by the physiotherapist and in the sensory room.
At the end of the training sessions, mothers were informed about the application of sensory integrity training to daily activities.Sensory integrity therapy room added tactile, proprioceptive, visual and auditory sensory materials as well as materials for vestibular sensation. Vestibular sensory materials, skateboard, swing, hammock, bowl, ball, ball pool, slide, climbing bar, trampoline, and balance board were used.
| Study group | Role | What they receive |
|---|---|---|
| sensory integration group | Experimental | This group was given the education of sensory integration with vestibular education. Receives: Other: The education of sensory integration with vestibular education |
| Control group | No intervention | The control group was given the education of sensory integration without vestibular education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory profile test
sensory profile test
Measured: 10 weeks
postrotary nystagmus test
postrotary nystagmus test
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Mar 2013
- Primary completion1 Jun 2013
- Study completion1 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957044
- Sponsor's protocol ID
- University
- Status last verified
- Jul 2020
- First submitted
- 17 May 2019
- Last updated
- 30 Jul 2020
- 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 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Rehabilitation on Sensory Profile and Postrotary Nystagmus in Autistic Children
- ClinicalTrials.gov ID
- NCT03957044
- Acronym / sponsor ID
- University
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Jul 2013 (actual)
- First posted
- 21 May 2019 (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 was conducted to clarify the effect of vestibular education for autistic children on "sensory profile" and "postrotary nystagmus". In the study, the results of the two groups were compared through the treatment of sensory integration: the once who got the education and the once who did not. For this study, 26 autistic children were included who joined the " Çatalca District Unit of Disabled the Project of No Disabilities ", who was diagnosed with autism, who was 3-10 years (older than 36 months younger than 11 years). For each child, the analysis of the sensory integration and nystagmus was applied twice; at the beginning and at the end of the research. At the beginning of the research, the children were divided into two groups randomly drawn by lots. The first group was given the education of sensory integration with vestibular education and the second group was given the education of sensory integration without vestibular education. Both groups were educated for 10 weeks, 2 days a week with 40- minute sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sensory integration group | Experimental | Other: The education of sensory integration with vestibular educationThis group was given the education of sensory integration with vestibular education. |
| Control group | No intervention | –The control group was given the education of sensory integration without vestibular education. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The study included autistic children aged between 3 and 10 years (36 months, 11 years old) who were diagnosed with autism according to the Diagnostic and Statistical Manual of Mental Disorders criteria. The families of all children who participated in the study were informed and their written permissions were obtained.
Key exclusion criteria (1 listed)
- Children who were not diagnosed with autism and who had previously received treatment for sensory integrity were excluded. The children who participated in the study had independent walking problems, those with lack of extremity, those with hip dislocation, those with postural anomalies, those who had an operation, those with infectious diseases, those with additional diagnoses with autism (such as cerebral palsy), patients with seizures, traumatic postpartum trauma, and motor development disorder. those with the postural disorder were not included in the study
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 |
|---|---|---|
| The education of sensory integration with vestibular educationTactical, proprioceptive, visual and auditory senses were used in sensory integrity training sessions. In this group, the training program on tactile, proprioceptive, visual and auditory sensory activities was carried out for 2 weeks and 40 minutes. Sensory integrity training was performed by the physiotherapist and in the sensory room. At the end of the training sessions, mothers were informed about the application of sensory integrity training to daily activities.Sensory integrity therapy room added tactile, proprioceptive, visual and auditory sensory materials as well as materials for vestibular sensation. Vestibular sensory materials, skateboard, swing, hammock, bowl, ball, ball pool, slide, climbing bar, trampoline, and balance board were used. | Other | sensory integration group |
Primary outcome
sensory profile test
Time frame: 10 weeks
sensory profile test
postrotary nystagmus test
Time frame: 10 weeks
postrotary nystagmus test
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 30 Jul 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing The education of sensory integration with vestibular education in people with Autistic Spectrum Disorder and Vestibular Disorder, run by Istinye University.
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: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 profile test (time frame: 10 weeks). The study lists 2 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 30 Jul 2020.