NCT03957044

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

May 17, 2019

Last Update Submit

July 28, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • sensory profile test

    sensory profile test

    10 weeks

  • postrotary nystagmus test

    postrotary nystagmus test

    10 weeks

Study Arms (2)

sensory integration group

EXPERIMENTAL

This group was given the education of sensory integration with vestibular education.

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.

Interventions

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.

sensory integration group

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum DisorderVestibular Diseases

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD, Associate Professor

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 21, 2019

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share