- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06373770
Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
"This study named effects of ayres sensory integration therapy versus conservative treatment in autism spectrum is a randomized clinical trail study.There is no evidence-based intervention protocol to treat sensory integration dysfunction in autism spectrum. This study may help finding best therapeutic treatment approach for sensory integration dysfunction results in repetitive behavior and impairments in functionality in autism spectrum.This study helps
- To evaluate best intervention plan for sensory integration dysfunction, Ayres sensory integration therapy versus conservative treatment in autism spectrum.
- To determine how many patients will be having what type of sensory integration dysfunction that come with autism spectrum leading to certain level of functional restrictions in Activity of Daily Livings (ADLs).
- Which type of sensory integration dysfunction having greater functional impairment and need to be focused more for intervention?
- To make better individualized rehabilitation treatment plan being an Occupational Therapist."
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Faisalabad, Punjab, Pakistan
- RICCER Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed cases of autism age range from 2 year to 8 years.
- All patients will be assed using sensory profile by Winnie Dunn.
- All the patients fulfilling the above-mentioned inclusion criteria will be assessed and evaluated by occupational therapist for sensory integration dysfunction.
Exclusion Criteria:
- All other patients not having diagnosed as autism spectrum criteria are excluded.
- All patients with sensory processing disorder assessed by using sensory profile.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ayres sensory integration therapy
A. Jean Ayres, is a theory and practice that targets a person's ability to process and internally integrate sensory information from their body and environment.
|
A. Jean Ayres, is a theory and practice that targets a person's ability to process and internally integrate sensory information from their body and environment.
Sensory information may be visual, auditory, tactile, proprioceptive, and/or vestibular in nature.
ASI uses individually tailored activities that utilize "just right" challenges to an individual's existing patterns of sensory processing and motor planning and encourage movement and organization of self in time and space.
ASI incorporates specialized equipment and materials in purposeful and playful activities in order to improve adaptive behavior.
|
|
Other: Behaviour therapy
The current treatment options for the core symptoms of autism are limited to psychosocial therapies, such as applied behavior analysis.
|
The current treatment options for the core symptoms of autism are limited to psychosocial therapies, such as applied behavior analysis.
Medications have been most effective in treating the associated behavioral symptoms of autism, though studies have examined potential benefits in some of the core symptoms of autism with certain medications, especially the repetitive behaviors often seen with this diagnosis.
Risperidone and aripiprazole are currently the only medications FDA approved for symptoms associated with autism spectrum disorders, targeting the irritability often seen with this diagnosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sensory profile by winnie dunn
Time Frame: 12 Months
|
sensory profile by winnie dunn willl be used to measure primary outcomes or initial assessment
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sensory profile by winnie dunn
Time Frame: 12 Months
|
sensory profile by winnie dunn will be used to measure secondary outcomes or post intervention/treatment reassessment
|
12 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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