the Effect of Vestibular Rehabilitation in Autistic Children
Primary Purpose
Autistic Spectrum Disorder, Vestibular Disorder, Sensory Integration Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The education of sensory integration with vestibular education
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sensory integration group
Control group
Arm Description
This group was given the education of sensory integration with vestibular education.
The control group was given the education of sensory integration without vestibular education.
Outcomes
Primary Outcome Measures
sensory profile test
sensory profile test
postrotary nystagmus test
postrotary nystagmus test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03957044
Brief Title
the Effect of Vestibular Rehabilitation in Autistic Children
Official Title
The Effect of Vestibular Rehabilitation on Sensory Profile and Postrotary Nystagmus in Autistic Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
June 1, 2013 (Actual)
Study Completion Date
July 1, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istinye University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Spectrum Disorder, Vestibular Disorder, Sensory Integration Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sensory integration group
Arm Type
Experimental
Arm Description
This group was given the education of sensory integration with vestibular education.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group was given the education of sensory integration without vestibular education.
Intervention Type
Other
Intervention Name(s)
The education of sensory integration with vestibular education
Intervention Description
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.
Primary Outcome Measure Information:
Title
sensory profile test
Description
sensory profile test
Time Frame
10 weeks
Title
postrotary nystagmus test
Description
postrotary nystagmus test
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
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the Effect of Vestibular Rehabilitation in Autistic Children
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