search
Back to results

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
Istinye University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Spectrum Disorder

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 17, 2019
    Last Updated
    July 28, 2020
    Sponsor
    Istinye University
    search

    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

    Learn more about this trial

    the Effect of Vestibular Rehabilitation in Autistic Children

    We'll reach out to this number within 24 hrs