NCT04740853

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

June 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

February 2, 2021

Last Update Submit

February 5, 2021

Conditions

Keywords

Dyslexia, sensory integration therapy, MOHO.

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 weeks

  • 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.

    2 weeks

Study Arms (2)

Sensory Integration Therapy+Special Education

EXPERIMENTAL

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.

Behavioral: Sensory Integration Therapy+Special Education

Special Education

ACTIVE COMPARATOR

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.

Behavioral: Sensory Integration Therapy+Special Education

Interventions

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.

Sensory Integration Therapy+Special EducationSpecial Education

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Had any secondary diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Remziye Akarsu

Istanbul, 34020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

June 15, 2020

Primary Completion

November 20, 2020

Study Completion

December 30, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations