- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067361
Effectiveness of Aerobic Exercises on the Autistic Children
October 4, 2021 updated by: Dr Amna Ayub PT, University of Faisalabad
Effectiveness of Aerobic Exercises on the Stereotypic Behaviors and Task Performance of Autistic Children: A Randomized Clinical Trial
Autism spectrum disorder (ASD) is a neurodevelopmental disorder manifesting stereotypic behaviors and problem in communication and social interaction.
Different physical therapy interventions like aerobics help to improve recurrent behaviors and task performance of autistic children.
This study was focused to see the effect of jogging on the stereotypic behaviors and task performance of autistic children.
A single blinded randomized study was conducted on 38 autistic children, randomly allocated to two groups, performing jogging and ball exercises.
Repetitive Behavior Scale-revised(RBS-R) and Jebsen Hand Function Test (JHFT) was used for assessment.
Exercise was performed for 3 weeks and 4 sessions per week.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Faisalābad, Punjab, Pakistan, 38000
- University of Faisalabad
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed children of autism spectrum disorder (ASD) by experts
- Have recognized stereotypic behaviors
- Age 6 to 20 years
- Independent to walk
- Both genders
- Parent and teachers willing to give consent
Exclusion Criteria:
- Unable to understand commands
- Have co-morbidities like schizophrenia or ADHD
- Having respiratory or cardiovascular problems
- Severe ASD
- Lower limb injury and disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
|
Jogging was performed for 20 minutes.
Jogging was performed by experimental group for 3 weeks and 4 sessions per week.
Ball exercises like stability ball roll, stability ball hug, stability ball catching, ball throwing and ball tapping exercises were for 10 minutes.
Ball exercises was performed by both groups for 3 weeks and 4 times per week .
|
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Active Comparator: Active control Group
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Ball exercises like stability ball roll, stability ball hug, stability ball catching, ball throwing and ball tapping exercises were for 10 minutes.
Ball exercises was performed by both groups for 3 weeks and 4 times per week .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Repetitive behavior scale revised (RBS-R)
Time Frame: 3 weeks
|
RBS-R was used to assess the stereotypic behaviors of autistic children.
It is 43 items questionnaire that is placed under six subscales.
The sub-scales are Stereotyped Behavior Subscale Self-Injurious Behavior Subscale Compulsive Behavior Subscale Ritualistic Behavior Subscale Sameness Behavior Subscale Restricted Behavior Subscale Each subscale has different characteristics, which are classified from 0 to 3 (behavior is severe).
Moreover, each behavior is also rated that how much this behavior occurs, cause interruption in activity and how much a child become agitated when he was interrupted.
Global score rating was used by calculating the scores of all the six subscales and total score was given in range of 1 to 100.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jebsen Hand Function Test (JHFT)
Time Frame: 3 weeks
|
JHFT was used to evaluate the task performance of autistic children.JHFT has seven variants and time was recorded, in seconds, taken by children to complete these seven tasks.
These seven tasks are writing, card turning, small common objects, simulated feeding, stacking, lifting large lightweight objects and lifting large heavy objects.
These piece of work was first performed by the non-dominant hand then by the dominant hand and at the end time required during all the task was summed up in minutes
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dr Sidra Majeed;PT, MSPP, University of Faisalabad
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2020
Primary Completion (Actual)
August 8, 2020
Study Completion (Actual)
October 26, 2020
Study Registration Dates
First Submitted
September 23, 2021
First Submitted That Met QC Criteria
October 4, 2021
First Posted (Actual)
October 5, 2021
Study Record Updates
Last Update Posted (Actual)
October 5, 2021
Last Update Submitted That Met QC Criteria
October 4, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUF/DR/MSPP/173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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