Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04740853 |
Other study ID # |
Rakarsu |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 15, 2020 |
Est. completion date |
December 30, 2020 |
Study information
Verified date |
February 2021 |
Source |
Biruni University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.