- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893679
Effects of Qigong Sensory Training on Sensory Modulation and Behavior in Children With Autism
Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by challenges in social interaction, communication, and a range of repetitive behaviors. Among these challenges, sensory processing abnormalities are highly prevalent, manifesting as hyper- or hypo-sensitivity to sensory stimuli, and can significantly impact daily functioning and quality of life. In sensory modulation there are difficulties in regulating and responding appropriately to sensory input from the environment. Sensory modulation can have a significant impact on the daily lives of individuals with autism, affecting their ability to engage in various activities and navigate social interactions. Autistic children also have repetitive behaviors, such as repetitive actions like self-stimulation behavior, or stimming. These behaviors can involve one part of the body, the entire body or an object. QST in which deep pressure with thumb apply on head, neck, trunk and limbs along deep breathing which give relaxation to body and have effect on sensory modulation and behavior in children with Autism. The intended project aims to evaluate the sensory modulation and behavior in children with autism spectrum disorder (ASD) through Qigong Sensory Training (QST).
A quasi-Experimental study will be conduct to evaluate the effect of QST on the sensory modulation and behavior of autistic children. 21 Participants will be included in the study with age of 4-12 years diagnosed with ASD. Participants will be received 15 mints massage therapy 2 times in a day and 5 days a week for 8 weeks. Before and after 8 week of intervention, Assessment of sensory modulation scale (ASMS) will be used to check the sensory modulation level and strength and difficulties questionnaire (SDQ) will be used to check the behavior. Data will be collected from Nishtar Hospital Multan. The pre and post intervention assessments will be done. The reliability and validity of tools are mentioned. The duration of study will be 10-months. Data will be analyzed with the help of SPSS 25.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Multan Khurd, Punjab Province, Pakistan, 60000
- Nishtar Medical University, Multan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 4 to12 years diagnosed with autism spectrum disorder.
- Male and Female will be included in study.
- Parental/guardian consent to participate in the study.
- Children do not receive any other intervention therapy during study
Exclusion Criteria:
- Children with severe physical disabilities that significantly impair their ability to participate in touch-based interventions, as determined by a qualified healthcare provider.
- Children diagnosed with severe psychiatric conditions other than autism spectrum disorder (ASD), including but not limited to schizophrenia, bipolar disorder, and severe anxiety disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Qigong sensory training
Participants will be received 15 mints massage therapy 2 times in a day and 5 days a week for 8 weeks.
Before and after 8 week of intervention, Assessment of sensory modulation scale (ASMS) will be used to check the sensory modulation level and strength and difficulties questionnaire (SDQ) will be used to check the behavior.
Data will be collected from Nishtar Hospital Multan.
The pre and post intervention assessments will be done.
|
Participants will be received 15 mints massage therapy 2 times in a day and 5 days a week for 8 weeks.
Before and after 8 week of intervention, Assessment of sensory modulation scale (ASMS) will be used to check the sensory modulation level and strength and difficulties questionnaire (SDQ) will be used to check the behavior.
Data will be collected from Nishtar Hospital Multan.
The pre and post intervention assessments will be done.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of sensory modulation scale (ASMS)
Time Frame: Baseline and 8 weeks
|
The 141 items in the ASMS comprise 3 scales of 30, 30 and 21 items in these scales.
First 30 items consist question of sensory over-responsive (SOR) and second 30 items consist questions of sensory under-responsive (SUR) and third 21 items consist questions of sensory seeking (SS) these all items use to evaluate children with mental, behavioural and neuro-developmental disorders, the cut of values of this questionnaire is given here.
The participant will be given 1 score of each item if they answer "Yes" and will be given 2 score if they answer "No", the total score of 1ST & 2ND items SOR and SUR are 60.
Minimum score, less than 30 show SOR and maximum score, greater than 30 show SUR and in 3rd item score less than 21 show SS.
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Baseline and 8 weeks
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Strength and difficulty questionnaire (SDQ)
Time Frame: Baseline and 8 weeks
|
"Strengths and Difficulties" Parent and Teacher reported questionnaire for children aged 04-17 years is a behavioral measuring tool.
The SDQ includes 25 items that examine a range of 'strengths and difficulties' as behavioral indicators of probable mental health disorders.
The items contribute to 5 subscales, each with 5 items and a minimum score ranging from 0 (lowest score) to 10 (highest score): conduct difficulties, hyperactivity/inattention, emotional signs, problems with peers, and social conduct.
The sum of the first 4 subscales yields a total difficulty score that ranges from 0 to 40
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Baseline and 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Yousaf, MSPT(Peads), Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR/AHS/24/0738
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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