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Sensory Integration Therapy in Children With Dyslexia (Dyslexia)

Primary Purpose

Dyslexia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sensory Integration Therapy+Special Education
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslexia focused on measuring Dyslexia, sensory integration therapy, MOHO.

Eligibility Criteria

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

Inclusion Criteria:

  • Were between the ages of 6 and 10 years
  • Diagnosed with dyslexia by a psychiatrist according to DSM-V criteria

Exclusion Criteria:

• Had any secondary diagnosis

Sites / Locations

  • Remziye Akarsu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sensory Integration Therapy+Special Education

Special Education

Arm Description

The therapy program was prepared and applied according to the Ayres theory and based on the basic principles of sensory integration therapy prepared by Parham depending on the evaluation results. Therapy was applied to the intervention group, with a 45-minute session+15 minutes of family information once a week for eight weeks, in addition to the special education sessions they received twice a week in special education institutions. The sensory integration therapy included sensory diet practices and activities consisting of vestibular, tactile, proprioceptive, auditory and visual stimuli. The intervention group continued special education sessions in special education and rehabilitation centers twice a week for eight weeks. In the special education sessions, reading, writing, sequencing, arithmetic, language, organization, memory studies were applied.

The control group continued special education sessions in special education and rehabilitation centers twice a week for eight weeks. Within the scope of special education sessions, reading, writing, sequencing, arithmetic, language, organization, memory studies were applied.

Outcomes

Primary Outcome Measures

The Sensory Profile Test
The Sensory Profile Test is an assessment tool for sensory modulation developed by Winnie Dunn and it is used to determine the types of sensory response during daily activities and which sensory systems are most affected. Functional performance is a valid and reliable assessment tool for measuring sensory processing skills. In the scale, there are 125 questions asked to parents, divided into three parts as sensory processing, modulation, and behavioral-emotional responses. It is evaluated according to the Likert scale (1 = Always, 2 = Frequently, 3 = Sometimes, 4 = Rarely, 5 = Never) with 9 factor scores consisting of these parameters. Typical performance, probably difference and definite difference score ranges are determined for each parameter. Total score for each parameter; There is an improvement from the absolute difference score range to the typical performance score range.
The Short Child Occupational Profile
The SCOPE is an assessment tool to evaluate children's activity participation within the framework of MOHO. This questionnaire consists 25 questions (4 questions from each performance area of MOHO and 5 questions for the environment) and it is scored 4-point likert scale. The higher scores mean better performance. The SCOPE is a scale with proven validity and reliability, in which activities, roles and tasks are evaluated comprehensively, the child's skills and environmental opportunities are examined.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
February 5, 2021
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT04740853
Brief Title
Sensory Integration Therapy in Children With Dyslexia
Acronym
Dyslexia
Official Title
Investigation of the Effectiveness of Sensory Integration Therapy in Children With Dyslexia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni 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
The aim of this study is to examine the sensory and functional effects of sensory integration therapy in children with dyslexia according to the Model of Human Occupation (MOHO). 35 participant (17 intervention, 18 control, aged 8.7;8.5 years) diagnosed with dyslexia were included in the study. In the special education and rehabilitation centers, where they were followed, both groups received special individual training sessions twice a week for eight weeks, and in addition to the intervention group, sensory integration therapy was applied once a week for eight weeks (45 minutes therapy, 15 minutes family briefing - 60 minutes in total). Sensory Profile Test was used for sensory processing evaluation and SCOPE (The Short Child Occupational Profile) for occupational performance analysis. Intervention results and intergroup scores were analyzed using the Wilcoxon Paired Two Sample Test and the Mann Whitney-U test.
Detailed Description
This study aims to examine the effect of sensory integration therapy on sensory modulation and daily functional performance in children with dyslexia, according to the occupational therapy model MOHO. The study was carried out in Biruni University Sensory Integration Unit on 35 participants ( intervention group:17, aged 8,7±0,85 years; control group:18, aged 8,5±1,1 years) with dyslexia. According to the results of the analysis made in the R program, it was calculated that the sample volume should be 35 at 80% Power. The investigators talked about the study with a special education and rehabilitation center. They will briefly ask the families of children with dyslexia who meet the inclusion criteria, during their routine education/therapy sessions, whether they might be interested in taking part in the study or not. Following this, the informed consent form was signed by the parents who accepted and were willing to volunteer to take part in the study, since the individuals participating in the study were under the age of 18. Children between the ages of 6 and 10 years who were diagnosed with dyslexia by a psychiatrist according to DSM-V criteria were included in the study. Children with any secondary diagnosis were excluded from the study. 40 participants were randomly divided into 20 control and 20 intervention groups using a random number table. Children in the intervention group were included in sensory integration therapy sessions at Biruni University Sensory Integration Unit for eight weeks, one session a week, 45 minutes sessions, and 15 minutes of family information. Both groups continued special education sessions in special education and rehabilitation centers twice a week for eight weeks. Three participants from the intervention group and two participants from the control group left the study. The socio-demographic data was collected and recorded, including age, parentage, gender, health status. During the evaluation phase, the Sensory Profile test and the SCOPE (The Short Child Occupational Profile) was applied to both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia
Keywords
Dyslexia, sensory integration therapy, MOHO.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensory Integration Therapy+Special Education
Arm Type
Experimental
Arm Description
The therapy program was prepared and applied according to the Ayres theory and based on the basic principles of sensory integration therapy prepared by Parham depending on the evaluation results. Therapy was applied to the intervention group, with a 45-minute session+15 minutes of family information once a week for eight weeks, in addition to the special education sessions they received twice a week in special education institutions. The sensory integration therapy included sensory diet practices and activities consisting of vestibular, tactile, proprioceptive, auditory and visual stimuli. The intervention group continued special education sessions in special education and rehabilitation centers twice a week for eight weeks. In the special education sessions, reading, writing, sequencing, arithmetic, language, organization, memory studies were applied.
Arm Title
Special Education
Arm Type
Active Comparator
Arm Description
The control group continued special education sessions in special education and rehabilitation centers twice a week for eight weeks. Within the scope of special education sessions, reading, writing, sequencing, arithmetic, language, organization, memory studies were applied.
Intervention Type
Behavioral
Intervention Name(s)
Sensory Integration Therapy+Special Education
Intervention Description
Sensory integration is a theory first put forward by Ayres in 1972. It is a neurological process that organizes sensory stimuli from our body and our environment for use in the daily life. When the sensory integrity organization of individuals is provided, it is possible to use their body effectively against the environment. Sensory integration therapy, which is defined as a physiologically based process by Ayres and Dunn, also provides changes in individuals' occupations.
Primary Outcome Measure Information:
Title
The Sensory Profile Test
Description
The Sensory Profile Test is an assessment tool for sensory modulation developed by Winnie Dunn and it is used to determine the types of sensory response during daily activities and which sensory systems are most affected. Functional performance is a valid and reliable assessment tool for measuring sensory processing skills. In the scale, there are 125 questions asked to parents, divided into three parts as sensory processing, modulation, and behavioral-emotional responses. It is evaluated according to the Likert scale (1 = Always, 2 = Frequently, 3 = Sometimes, 4 = Rarely, 5 = Never) with 9 factor scores consisting of these parameters. Typical performance, probably difference and definite difference score ranges are determined for each parameter. Total score for each parameter; There is an improvement from the absolute difference score range to the typical performance score range.
Time Frame
2 weeks
Title
The Short Child Occupational Profile
Description
The SCOPE is an assessment tool to evaluate children's activity participation within the framework of MOHO. This questionnaire consists 25 questions (4 questions from each performance area of MOHO and 5 questions for the environment) and it is scored 4-point likert scale. The higher scores mean better performance. The SCOPE is a scale with proven validity and reliability, in which activities, roles and tasks are evaluated comprehensively, the child's skills and environmental opportunities are examined.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Were between the ages of 6 and 10 years Diagnosed with dyslexia by a psychiatrist according to DSM-V criteria Exclusion Criteria: • Had any secondary diagnosis
Facility Information:
Facility Name
Remziye Akarsu
City
İstanbul
ZIP/Postal Code
34020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sensory Integration Therapy in Children With Dyslexia

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