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临床试验/NCT04740853
NCT04740853已完成不适用

Investigation of the Effectiveness of Sensory Integration Therapy in Children With Dyslexia

Biruni University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
The Sensory Profile Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Had any secondary diagnosis

结局指标

主要结局

The Sensory Profile Test

时间窗: 2 weeks

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

时间窗: 2 weeks

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.

次要结局

未报告次要终点

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Remziye Akarsu

Lecturer

Biruni University

研究点 (2)

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