NCT05045339

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

First Submitted

Initial submission to the registry

September 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
3.4 years until next milestone

Study Start

First participant enrolled

February 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

September 6, 2021

Last Update Submit

July 29, 2025

Conditions

Keywords

ball exercisesphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Stereotypic Behaviors

    Stereotypic behavior was the sole parameter assessed in this study using the Repetitive Behavior Scale-Revised (RBS-R), a well-established instrument known for its strong reliability and validity. The RBS-R was employed to evaluate self-stimulatory behaviors in children with Autism Spectrum Disorder (ASD). This 43-item questionnaire is organized into six distinct subscales, each targeting a specific dimension of repetitive behavior.

    Two months

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Procedure: Ball Exercises

Control Group

NO INTERVENTION

No exercises were performed in control group

Interventions

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.

Exercise Group

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Dr Sidra Majeed; PT

    The University of Faisalabad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 16, 2021

Study Start

February 9, 2025

Primary Completion

May 20, 2025

Study Completion

May 28, 2025

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations