DyslexiaDyslexiaNCT04740853
Sensory Integration Therapy in Children With Dyslexia
A study testing Sensory Integration Therapy+Special Education in people with Dyslexia, run by Biruni University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- Sensory Integration Therapy+Special Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Were between the ages of 6 and 10 years
- Diagnosed with dyslexia by a psychiatrist according to DSM-V criteria
Who cannot join
- Had any secondary diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Sensory Integration Therapy in Children With Dyslexia
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.
Read the 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.
- Conditions
- Dyslexia
- Being tested
- Sensory Integration Therapy+Special Education
- Keywords
- Dyslexia, sensory integration therapy, MOHO.
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Integration Therapy+Special EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sensory Integration Therapy+Special Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start15 Jun 2020
- Primary completion20 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remziye Akarsu, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740853
- Sponsor's protocol ID
- Rakarsu
- Acronym
- Dyslexia
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Sensory Integration Therapy in Children With Dyslexia
- ClinicalTrials.gov ID
- NCT04740853
- Acronym / sponsor ID
- Dyslexia / Rakarsu
- Conditions
- Dyslexia
- Keywords
- Dyslexia, sensory integration therapy, MOHO.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Integration Therapy+Special Education | Experimental | Behavioral: Sensory Integration Therapy+Special EducationThe 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. |
| Special Education | Active comparator | Behavioral: Sensory Integration Therapy+Special EducationThe 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Were between the ages of 6 and 10 years
- Diagnosed with dyslexia by a psychiatrist according to DSM-V criteria
Key exclusion criteria (1 listed)
- Had any secondary diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Integration Therapy+Special EducationSensory 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. | Behavioural | Sensory Integration Therapy+Special Education, Special Education |
Primary outcome
The Sensory Profile Test
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Integration Therapy+Special Education in people with Dyslexia, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sensory Profile Test (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.