Autism Spectrum DisorderNCT05045339
Ball Exercises and Stereotypic Behavior in Autism Spectrum Disorder
A study testing Ball Exercises in people with Autism Spectrum Disorder, run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Ball Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Feb 2025to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Faisalabad
Faisalābad, Punjab Province, 38000
About this study
Official title: Effectiveness of Ball Exercises on the Stereotypic Behavior of Children With Autism Spectrum Disorder
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Ball Exercises
- Keywords
- ball exercises, physical therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ball ExercisesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Five different ball exercises were implemented for 35 minutes, 3 sessions per week for 2 months. Receives: Procedure: Ball Exercises |
| Control Group | No intervention | No exercises were performed in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start9 Feb 2025
- Primary completion20 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Izza Ayub; PT, University of Faisalabad
- Investigators
- Dr Sidra Majeed; PT, Study director, The University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045339
- Sponsor's protocol ID
- TUF/DR/DPT/157
- Status last verified
- Jul 2025
- First submitted
- 6 Sep 2021
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ball Exercises on the Stereotypic Behavior of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05045339
- Acronym / sponsor ID
- TUF/DR/DPT/157
- Conditions
- Autism Spectrum Disorder
- Keywords
- ball exercises, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 9 Feb 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Procedure: Ball ExercisesFive different ball exercises were implemented for 35 minutes, 3 sessions per week for 2 months. |
| Control Group | No intervention | –No exercises were performed in control group |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ball ExercisesDifferent ball exercises which include stability ball roll, stability ball hug, catching, throwing was performed. Along with these exercises, ball tapping exercise was also performed. | Procedure or surgery | Exercise Group |
Primary outcome
Stereotypic Behaviors
Time frame: Two months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Sidra Majeed; PT study director
The University of Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ball Exercises in people with Autism Spectrum Disorder, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stereotypic Behaviors (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.