NCT06893679

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

March 19, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

Qigong sensory trainingAutismSensory ModulationStrengthBehavior

Outcome Measures

Primary Outcomes (2)

  • Assessment of sensory modulation scale (ASMS)

    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.

    Baseline and 8 weeks

  • Strength and difficulty questionnaire (SDQ)

    "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

    Baseline and 8 weeks

Study Arms (1)

Qigong sensory training

EXPERIMENTAL

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.

Other: Qigong sensory training

Interventions

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.

Qigong sensory training

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nishtar Medical University, Multan

Multan Khurd, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Autistic DisorderBehavior

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Muhammad Yousaf, MSPT(Peads)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 25, 2025

Study Start

March 17, 2025

Primary Completion

August 17, 2025

Study Completion

September 17, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations