Attention Deficit Disorder With HyperactivityASI-ADHDNCT05718427
Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD
A study testing Ayres Sensory Integration Therapy in people with Attention Deficit Disorder With Hyperactivity and Sensory Integration Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) is a very common neurodevelopmental disorder in childhood characterized by short attention span, impulsivity and hyperactivity. It is also known that sensory integration problems are seen together with the basic symptoms of ADHD. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Sensory Integration Disorder, Motor Activity
- What is being tested?
- Ayres Sensory Integration Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2023to 30 Aug 2024
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- According to the DSM-V criteria diagnosed with ADHD-C type,
- To be on medication,
- To be between the ages of 6 and 8,
- To attend school.
Who cannot join
- Having previously received sensory integration therapy,
- Having another diagnosis in addition to the ADHD diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ayres Sensory Integration Therapy on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial
Attention Deficit Hyperactivity Disorder (ADHD) is a very common neurodevelopmental disorder in childhood characterized by short attention span, impulsivity and hyperactivity. It is also known that sensory integration problems are seen together with the basic symptoms of ADHD. Studies indicate that children with ADHD have difficulties in perceiving and processing sensory stimuli, and in relation to this, they have difficulty in producing appropriate sensory responses at school, at home and in social environments. However, it was observed that the interventions related to ADHD did not focus on the sensory-motor dimension enough, and focused more on cognitive or social skills. Although current research indicates the presence of sensory integration disorder in children with ADHD, there are no studies showing the effectiveness of sensory integration intervention. Our study was planned to examine the effect of Ayres Sensory Integration intervention on sensory-motor, cognitive, behavioral skills and social participation in children with ADHD. Materials and Methods: After the evaluation, 90 children with ADHD will be included in the study by dividing them into intervention (n=45) and control (n=45) groups by simple randomization method. Ayres Sensory Integration Therapy intervention will be applied to the intervention group for 10 weeks, 3 times a week, with a session duration of 1 hour, while the control group will continue the drug treatment and after a waiting period of 10 weeks, Ayres Sensory Integration Therapy will be applied after the second evaluation. Participants, Sensory Profile (SP), Sensory Integration and Praxis Test (SIPT), Emotion Regulation Checklist (ERC), Stroop Test TBAG Form (Stroop TBAG), Childhood Executive Functions Inventory (CHEXI), Participation and Environment Scale for Children and Adolescents (PEM-CY), Conners Teacher Rating Scale (CTRS), Conners Parent Rating Scale (CPRS), Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) and Goal Achievement Scale (GAS) both before and before intervention. and post-group change as well as between-group differences will be evaluated.
Read the detailed description
Although there are studies in the literature showing the presence of Sensory Integration Disorder (SID) in children with ADHD, most researchers have studied a similar profile, such as sensory modulation disorder, and few have investigated all components of sensory integration (such as sensory perception, praxis). More research is needed to confirm the effects of Ayres Sensory Integration (ASI) therapy in children with ADHD and the possible relationship between SID-based difficulties in activities of daily living and ADHD symptoms. In our study, it was aimed to investigate the effect of Ayres Sensory Integration therapy on sensory, motor, cognitive, behavioral and social participation in children with ADHD in the light of extensive literature and recommendations.
ASI therapy will be applied to the intervention group, and the first assessment will be applied to the control group and the second assessment will be made 10 weeks later. However, after a 10-week waiting period, ASI therapy intervention will be applied after the second evaluation so that the children in the control group can also benefit from the intervention. ASI therapy intervention will be applied for 10 weeks, 3 times a week, with a session duration of 1 hour. Inclusion criteria: Being diagnosed with ADHD according to the DSM-V criteria, taking medication, being between the ages of 6 and 8 and attending school. Exclusion criteria: Having previously received sensory integration therapy, having another diagnosis in addition to the ADHD diagnosis.
In addition to drug therapy, ASI therapy will be applied to children in the intervention group. In the intervention group, ASI therapy will be performed 3 days a week for a total of 10 weeks, 60 minutes each session, in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM). A manualized protocol will be followed based on the principles of ASI-FM, Ayres sensory integration.
The children in the control group will be given only drug treatment. The second evaluation will be repeated 10 weeks after the first evaluation. In order for the children in the control group to benefit from sensory integration therapy, after a 10-week waiting period, after the result measurements are applied again, ASI therapy will be applied 3 days a week with 60 minutes each session in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM).
- Conditions
- Attention Deficit Disorder With Hyperactivity, Sensory Integration Disorder, Motor Activity, Cognitive Deficit in Attention, Behavior Hyperactive, Emotional Regulation
- Being tested
- Ayres Sensory Integration Therapy
- Keywords
- ADHD, Sensory Integration, Motor Performance
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Activity, Spasm, Emotional Regulation, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayres Sensory Integration TherapyBehavioural
Ayres sensory integration theory provides evidence from basic and applied science about the ability to receive, sort, process, and make use of the information originating from the body and the environment and perceived by our senses (touch, gravity, body position and movement, sight, smell, hearing, taste). This sensory information goes to the brain, where it is organized and interpreted. As a result, we form a plan of action that allows us to have an adaptive response appropriate for the demands of the environment. A thorough assessment guides the preparation of goals addressing the referring concerns and the recommendations for intervention. Ayres Sensory Integration intervention is provided within the context of professional practice. It is designed to improve sensory perceptual abilities, self-regulation, motor skills, and praxis. In doing so, it supports the client's ability to show improved behavior, learning, and social participation.
| Study group | Role | What they receive |
|---|---|---|
| Ayres Sensory Integration Therapy Group | Experimental | Ayres Sensory Integration (ASI) therapy will be applied to children in the intervention group. In the intervention group, Ayres Sensory Integration Therapy will be performed 3 days a week for a total of 10 weeks, 60 minutes each session, in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM). A manualized protocol will be followed based on the principles of ASI-FM, Ayres sensory integration. Receives: Behavioral: Ayres Sensory Integration Therapy |
| Waiting Group | No intervention | The children in the control group will be wait just 10 weeks. The second evaluation will be repeated 10 weeks after the first evaluation. In order for the children in the control group to benefit from sensory integration therapy, after a 10-week waiting period, after the result measurements are applied again, Ayres sensory integration therapy will be applied 3 days a week with 60 minutes each session in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Integration and Praxis Test (SIPT)
Developed by Ayres, is a standardized performance-based observational test that evaluates sensory perception and sensory perception-based skills in detail in children between the ages of 4 and 8 years and 11 months. SIPT, is one of the important gold tests in evaluating sensory development.
Measured: SIPT will also be used in the initial and final assessment at week 1 and week 12. SIPT measures the change in sensory skills.Getting a high score on the test means good performance.
Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2)
Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) is a test developed for children aged 4-21 and developed to measure the motor functions of children. BOT-2 is an observational assessment evaluating motor performance, consisting of 8 subtests and 12 items in total. It consists of fine motor accuracy, fine motor integration, dexterity, bilateral coordination, balance, upper extremity coordination, endurance, speed and agility subtests.
Measured: BOT-2 will also be used in the initial and final assessment at week 1 and week 12. BOT-2 measures the change in motor skills. Getting a high score on the test means good performance.
Goal Attainment Scale (GAS)
The Goal Attainment Scale (GAS) is used to evaluate the achievement of functional therapy goals in children receiving treatment in pediatric services. It helps to set priorities and clear goals for intervention. It provides the child's continuous interest in the set goals and offers a person-centered approach. The determined goals should be specific, measurable, achievable, relevant and well-timed. While applying GAS, goals are set for the child and possible outcomes are defined for each goal. After a certain intervention, the functional status of the child is determined again. GAS consists of 5 points as -2, -1, 0, +1 and +2. A score of -2 indicates the child's pre-intervention baseline level, a score of -1 indicates a development below the expected attainment level, a score of 0 indicates an expected attainment level, a score of +1 indicates a better-than-expected achievement, and a score of +2 indicates that the child performs much better than expected.
Measured: GAS will also be used in the initial and final assessment at week 1 and week 12. GAS measures the change in behavior. Maximum +2 and minimum -2 points are taken. +2 means the best result.
Secondary outcomes (4)
Emotional Regulation Checklist (ERC)
The Emotional Regulation Checklist (ERC) is a 24-item scale developed by Shields and Cicchetti to evaluate the emotion regulation competence of children aged 6-13 and can be evaluated by both parents and teachers.
Measured: ERC will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about emotional regulation behaviour in child. Getting a high score on the test means good performance.
Childhood Executive Functions Inventory (CHEXI)
Childhood Executive Functions Inventory (CHEXI) is a scale consisting of 26 questions for children aged 4-12 years, developed by Lisa B. Thorell and Lilianne Nyberg as a measurement focusing especially on executive functions.
Measured: CHEXI will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about executive functions skills in child. Getting a high score on the test means good performance.
Participation and Environment Scale for Children and Youth (PEM-CY)
The Participation and Environment Scale for Children and Youth (PEM-CY) is a 28-item questionnaire assessing participation in children aged 5-17 years. It is a family-reported scale that questions the child's participation in school, home and society.
Measured: PEM-CY will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about participation area in child. Getting a high score on the test means good performance.
Stroop Test TBAG Form (Stroop TBAG)
The Stroop Test TBAG Form (Stroop TBAG) is one of the golden tests used to measure selective attention and ability to shift attention, focusing on the color used in the spelling of the word and the disruptive effect of the color in the pronunciation of the word.
Measured: Stroop TBAG will also be used in the initial and final assessment at week 1 and week 12. Stroop TBAG measures the change in cognitive skills. Getting a high score on the test means good performance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start29 Mar 2023
- Primary completion18 Feb 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Medipol University
- Responsible party
- Principal investigator, Busra Kaplan Kilic, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718427
- Sponsor's protocol ID
- 2022/44353
- Acronym
- ASI-ADHD
- Status last verified
- Sep 2024
- First submitted
- 27 Dec 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ayres Sensory Integration Therapy on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05718427
- Acronym / sponsor ID
- ASI-ADHD / 2022/44353
- Conditions
- Attention Deficit Disorder With Hyperactivity, Sensory Integration Disorder, Motor Activity, Cognitive Deficit in Attention, Behavior Hyperactive, Emotional Regulation
- Keywords
- ADHD, Sensory Integration, Motor Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara Medipol University
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 8 Feb 2023 (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.
Attention Deficit Hyperactivity Disorder (ADHD) is a very common neurodevelopmental disorder in childhood characterized by short attention span, impulsivity and hyperactivity. It is also known that sensory integration problems are seen together with the basic symptoms of ADHD. Studies indicate that children with ADHD have difficulties in perceiving and processing sensory stimuli, and in relation to this, they have difficulty in producing appropriate sensory responses at school, at home and in social environments. However, it was observed that the interventions related to ADHD did not focus on the sensory-motor dimension enough, and focused more on cognitive or social skills. Although current research indicates the presence of sensory integration disorder in children with ADHD, there are no studies showing the effectiveness of sensory integration intervention. Our study was planned to examine the effect of Ayres Sensory Integration intervention on sensory-motor, cognitive, behavioral skills and social participation in children with ADHD. Materials and Methods: After the evaluation, 90 children with ADHD will be included in the study by dividing them into intervention (n=45) and control (n=45) groups by simple randomization method. Ayres Sensory Integration Therapy intervention will be applied to the intervention group for 10 weeks, 3 times a week, with a session duration of 1 hour, while the control group will continue the drug treatment and after a waiting period of 10 weeks, Ayres Sensory Integration Therapy will be applied after the second evaluation. Participants, Sensory Profile (SP), Sensory Integration and Praxis Test (SIPT), Emotion Regulation Checklist (ERC), Stroop Test TBAG Form (Stroop TBAG), Childhood Executive Functions Inventory (CHEXI), Participation and Environment Scale for Children and Adolescents (PEM-CY), Conners Teacher Rating Scale (CTRS), Conners Parent Rating Scale (CPRS), Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) and Goal Achievement Scale (GAS) both before and before intervention. and post-group change as well as between-group differences will be evaluated.
Detailed description
Although there are studies in the literature showing the presence of Sensory Integration Disorder (SID) in children with ADHD, most researchers have studied a similar profile, such as sensory modulation disorder, and few have investigated all components of sensory integration (such as sensory perception, praxis). More research is needed to confirm the effects of Ayres Sensory Integration (ASI) therapy in children with ADHD and the possible relationship between SID-based difficulties in activities of daily living and ADHD symptoms. In our study, it was aimed to investigate the effect of Ayres Sensory Integration therapy on sensory, motor, cognitive, behavioral and social participation in children with ADHD in the light of extensive literature and recommendations.
ASI therapy will be applied to the intervention group, and the first assessment will be applied to the control group and the second assessment will be made 10 weeks later. However, after a 10-week waiting period, ASI therapy intervention will be applied after the second evaluation so that the children in the control group can also benefit from the intervention. ASI therapy intervention will be applied for 10 weeks, 3 times a week, with a session duration of 1 hour. Inclusion criteria: Being diagnosed with ADHD according to the DSM-V criteria, taking medication, being between the ages of 6 and 8 and attending school. Exclusion criteria: Having previously received sensory integration therapy, having another diagnosis in addition to the ADHD diagnosis.
In addition to drug therapy, ASI therapy will be applied to children in the intervention group. In the intervention group, ASI therapy will be performed 3 days a week for a total of 10 weeks, 60 minutes each session, in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM). A manualized protocol will be followed based on the principles of ASI-FM, Ayres sensory integration.
The children in the control group will be given only drug treatment. The second evaluation will be repeated 10 weeks after the first evaluation. In order for the children in the control group to benefit from sensory integration therapy, after a 10-week waiting period, after the result measurements are applied again, ASI therapy will be applied 3 days a week with 60 minutes each session in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Ayres Sensory Integration Therapy Group | Experimental | Behavioral: Ayres Sensory Integration TherapyAyres Sensory Integration (ASI) therapy will be applied to children in the intervention group. In the intervention group, Ayres Sensory Integration Therapy will be performed 3 days a week for a total of 10 weeks, 60 minutes each session, in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM). A manualized protocol will be followed based on the principles of ASI-FM, Ayres sensory integration. |
| Waiting Group | No intervention | –The children in the control group will be wait just 10 weeks. The second evaluation will be repeated 10 weeks after the first evaluation. In order for the children in the control group to benefit from sensory integration therapy, after a 10-week waiting period, after the result measurements are applied again, Ayres sensory integration therapy will be applied 3 days a week with 60 minutes each session in accordance with the Ayres Sensory Integration Fidelity Measure (ASI-FM). |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- According to the DSM-V criteria diagnosed with ADHD-C type,
- To be on medication,
- To be between the ages of 6 and 8,
- To attend school.
Key exclusion criteria (2 listed)
- Having previously received sensory integration therapy,
- Having another diagnosis in addition to the ADHD 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 |
|---|---|---|
| Ayres Sensory Integration TherapyAyres sensory integration theory provides evidence from basic and applied science about the ability to receive, sort, process, and make use of the information originating from the body and the environment and perceived by our senses (touch, gravity, body position and movement, sight, smell, hearing, taste). This sensory information goes to the brain, where it is organized and interpreted. As a result, we form a plan of action that allows us to have an adaptive response appropriate for the demands of the environment. A thorough assessment guides the preparation of goals addressing the referring concerns and the recommendations for intervention. Ayres Sensory Integration intervention is provided within the context of professional practice. It is designed to improve sensory perceptual abilities, self-regulation, motor skills, and praxis. In doing so, it supports the client's ability to show improved behavior, learning, and social participation. | Behavioural | Ayres Sensory Integration Therapy Group |
Primary outcome
Sensory Integration and Praxis Test (SIPT)
Time frame: SIPT will also be used in the initial and final assessment at week 1 and week 12. SIPT measures the change in sensory skills.Getting a high score on the test means good performance.
Developed by Ayres, is a standardized performance-based observational test that evaluates sensory perception and sensory perception-based skills in detail in children between the ages of 4 and 8 years and 11 months. SIPT, is one of the important gold tests in evaluating sensory development.
Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2)
Time frame: BOT-2 will also be used in the initial and final assessment at week 1 and week 12. BOT-2 measures the change in motor skills. Getting a high score on the test means good performance.
Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) is a test developed for children aged 4-21 and developed to measure the motor functions of children. BOT-2 is an observational assessment evaluating motor performance, consisting of 8 subtests and 12 items in total. It consists of fine motor accuracy, fine motor integration, dexterity, bilateral coordination, balance, upper extremity coordination, endurance, speed and agility subtests.
Goal Attainment Scale (GAS)
Time frame: GAS will also be used in the initial and final assessment at week 1 and week 12. GAS measures the change in behavior. Maximum +2 and minimum -2 points are taken. +2 means the best result.
The Goal Attainment Scale (GAS) is used to evaluate the achievement of functional therapy goals in children receiving treatment in pediatric services. It helps to set priorities and clear goals for intervention. It provides the child's continuous interest in the set goals and offers a person-centered approach. The determined goals should be specific, measurable, achievable, relevant and well-timed. While applying GAS, goals are set for the child and possible outcomes are defined for each goal. After a certain intervention, the functional status of the child is determined again. GAS consists of 5 points as -2, -1, 0, +1 and +2. A score of -2 indicates the child's pre-intervention baseline level, a score of -1 indicates a development below the expected attainment level, a score of 0 indicates an expected attainment level, a score of +1 indicates a better-than-expected achievement, and a score of +2 indicates that the child performs much better than expected.
4 secondary outcomes
Emotional Regulation Checklist (ERC)
Time frame: ERC will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about emotional regulation behaviour in child. Getting a high score on the test means good performance.
Childhood Executive Functions Inventory (CHEXI)
Time frame: CHEXI will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about executive functions skills in child. Getting a high score on the test means good performance.
Participation and Environment Scale for Children and Youth (PEM-CY)
Time frame: PEM-CY will also be used in the initial and final assessment at week 1 and week 12. The test provides subjective data about participation area in child. Getting a high score on the test means good performance.
Stroop Test TBAG Form (Stroop TBAG)
Time frame: Stroop TBAG will also be used in the initial and final assessment at week 1 and week 12. Stroop TBAG measures the change in cognitive skills. Getting a high score on the test means good performance.
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 2 Oct 2024.
- 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 Ayres Sensory Integration Therapy in people with Attention Deficit Disorder With Hyperactivity and Sensory Integration Disorder, run by Hacettepe 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 4 inclusion and 2 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 2 Oct 2024. 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?
Sensory Integration and Praxis Test (SIPT) (time frame: SIPT will also be used in the initial and final assessment at week 1 and week 12. SIPT measures the change in sensory skills.Getting a high score on the test means good performance.). The study lists 3 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 2 Oct 2024.