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Ball Exercises and Stereotypic Behavior in Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ball Exercises
Sponsored by
University of Faisalabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring ball exercises, physical therapy

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children diagnosed with ASD through experts
  • Having recognized stereotypic behavior
  • Having Intellectual Deficit (ID) and Attention Deficit Hyperactive Disorder (ADHD)
  • Age ranging between 4-16 years
  • Consented to take part

Exclusion Criteria:

  • Having co-morbidities like schizophrenia and developmental delays
  • Severe cases of ASD
  • Showing aggressive behavior
  • Having disease of cardiovascular or respiratory system
  • Children unable to follow the command for exercise completely

Sites / Locations

  • The University of Faisalabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Group

Control Group

Arm Description

Five different ball exercises were implemented for 35 minutes, 3 sessions per week for 2 months.

No exercises were performed in control group

Outcomes

Primary Outcome Measures

Stereotypic Behaviors
Repetitive behavior scale revised (RBS-R) was used to rate stereotypic behaviors in children with ASD. It is a 43 items questionnaire that is placed under six subscales. Stereotyped behavior subscale, self-injurious behavior subscale, compulsive behavior subscale, ritualistic behavior subscale, sameness behavior subscale and restricted behavior subscale are the six subscales of RBS-R. Each subscale has different characteristics which are classified as 0 (behavior is not present at all), 1 (behavior is mildly present), 2 (behavior is moderately present) and 3 (behavior is severe). Moreover, each behavior was also rated that how much this behavior occurs, cause interruption in activity and how much child become agitated when he was interrupted.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2021
Last Updated
September 28, 2021
Sponsor
University of Faisalabad
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1. Study Identification

Unique Protocol Identification Number
NCT05045339
Brief Title
Ball Exercises and Stereotypic Behavior in Autism Spectrum Disorder
Official Title
Effectiveness of Ball Exercises on the Stereotypic Behavior of Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
May 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Faisalabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Autism spectrum disorder (ASD) is a neuro-behavioral disorder associated with repetitive movements. The role of physical therapist towards an autistic child is most neglected one. Therefore, the objective of this study was to see the effectiveness of different ball exercise on stereotypic behavior of children with ASD. Different ball exercises were implemented for 2 months, 3 sessions per week and every session consist of 35 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
ball exercises, physical therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Five different ball exercises were implemented for 35 minutes, 3 sessions per week for 2 months.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No exercises were performed in control group
Intervention Type
Procedure
Intervention Name(s)
Ball Exercises
Intervention Description
Different ball exercises which include stability ball roll, stability ball hug, catching, throwing was performed. Along with these exercises, ball tapping exercise was also performed. Exercises were performed with 55 and 65 inch gym ball and a small regular plastic ball.
Primary Outcome Measure Information:
Title
Stereotypic Behaviors
Description
Repetitive behavior scale revised (RBS-R) was used to rate stereotypic behaviors in children with ASD. It is a 43 items questionnaire that is placed under six subscales. Stereotyped behavior subscale, self-injurious behavior subscale, compulsive behavior subscale, ritualistic behavior subscale, sameness behavior subscale and restricted behavior subscale are the six subscales of RBS-R. Each subscale has different characteristics which are classified as 0 (behavior is not present at all), 1 (behavior is mildly present), 2 (behavior is moderately present) and 3 (behavior is severe). Moreover, each behavior was also rated that how much this behavior occurs, cause interruption in activity and how much child become agitated when he was interrupted.
Time Frame
Two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children diagnosed with ASD through experts Having recognized stereotypic behavior Having Intellectual Deficit (ID) and Attention Deficit Hyperactive Disorder (ADHD) Age ranging between 4-16 years Consented to take part Exclusion Criteria: Having co-morbidities like schizophrenia and developmental delays Severe cases of ASD Showing aggressive behavior Having disease of cardiovascular or respiratory system Children unable to follow the command for exercise completely
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Sidra Majeed; PT, MSPP
Organizational Affiliation
The University of Faisalabad
Official's Role
Study Director
Facility Information:
Facility Name
The University of Faisalabad
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ball Exercises and Stereotypic Behavior in Autism Spectrum Disorder

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