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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05718362
Other study ID # CORAKCI-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2023
Est. completion date May 24, 2023

Study information

Verified date May 2023
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address specific underlying sensorimotor issues that may affect children's performance during daily routines and occupations. The intervention takes place in the context of play, emphasizes the active participation of the child, involves a collaborative relationship between the occupational therapist and the child, and focuses on participation-oriented outcomes that are collected at regular intervals throughout the intervention program. In general, its content is to improve the child's occupational performance. The program, which will be carried out in accordance with the Ayres Sensory Integration Fidelity Measure®, it is aimed to reduce the autism-specific symptoms of the child with autism and the dependence of the child on the caregiver in self-care activities. It is predicted that this whole process will increase the participation and his performance of the child with autism in his occupations related to his daily life. H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the child with autism spectrum disorder.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date May 24, 2023
Est. primary completion date May 24, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 10 Years
Eligibility Inclusion Criteria: - Children diagnosed with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition - Level 1 (requiring support) and Level 2 (requiring substantial support) are severity levels for Autism Spectrum Disorder - Age at first and second test between 3 years and 10 years Exclusion Criteria: - Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Ayres Sensory Integration Therapy
It is an intervention method whose effectiveness is questioned. It is a therapy program applied according to Ayres Sensory Integration Fidelity Measure.
Home Program
These are the activities created for the participants (both intervention and control groups) and to be done in the home environment.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occupational Performance Occupational performance will be evaluated with Canadian Occupational Performance Measure (COPM). The measure is a goal-oriented, individualized, client-centered tool in which participants can set different goals in self-care, productivity, and leisure.
The measure is a semi-structured assessment applied to determine the daily activities that participants have difficulty with.
All activities said by the participants are scored between 1-10 points and the first five activities are selected.
These activities are also scored between 1-10 points according to performance and satisfaction.
Scores are compared by applying the same scale after the intervention.
4 months
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