Autistic Disorder of Childhood Onset With Full SyndromeNCT04593576
Impact of Sports Activity on Pragmatic Skills of Children
A study testing Physical activity protocol/out door sports and Intensive table teaching speech therapy in people with Autistic Disorder of Childhood Onset With Full Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
To investigate the effects of structured physical exercises/outdoor sports on social interaction/communication skills of children with Autism in Pakistan. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Autistic Disorder of Childhood Onset With Full Syndrome
- What is being tested?
- Physical activity protocol/out door sports and Intensive table teaching speech therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2020to 10 Apr 2021
- 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 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female students with Autism (mild-moderate)
- Participants will be screened on short sensory profile, fulfilling the criteria of typical performance and probable difference will be included.
Who cannot join
- individuals with Autism along with any comorbid condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Outdoor Sports Activities on Pragmatic Language Skills for Children With Autism in Pakistan.
To investigate the effects of structured physical exercises/outdoor sports on social interaction/communication skills of children with Autism in Pakistan.
Read the detailed description
The word Autism is derived from the Latin word "Autos'' which means "self" - immersion in one's own world. Autism is a disorder that manifests itself in early childhood, is disabling in many cases and is characterized by severe deficits in communication, social interaction, speech/language delays, sensory issues, repetitive and stereotyped behavior, limited interests. Autism was first described as a disease, by an American physician; Autism later came to be known as ASD (Autism spectrum Disorder) due to numerous disorders, various combinations of disorders, multiple unknown etiologies, subtypes and dynamics of the evolving disease. Autism is on the rise with a prevalence rate of 1-2% of infant population. In 2014, the 67th World Health assembly passed a resolution for "Comprehensive and Co-ordinated efforts for the management of the Autism Spectrum Disorders "which was supported by 60 countries, showing the relevance of the pathology. Research on Autism has increased recently, and publications have nearly doubled in the last 5 years, as this spectrum of disorders continues to baffle doctors and scientists and has no cure till now, but can only be managed.
Benefits of physical exercises/sports have been researched, discussed and documented in great detail in the past. But the purpose of this research study is to explore the (Pragmatic communication and social interaction) benefits of specific sports/physical exercises for children aged 5-7 years who are on the spectrum, children with ASD diagnosis. Psychiatrists maintain that certain brain connections develop in ASD children if they regularly indulge / participate in particular sports like athletics (running, jogging, other track events), hiking (exposure to nature), swimming, cycling, horse- back riding, team sports like; basketball, soccer etc. The co-ordination between right and left sides of the body is more important in these sports. Team sports are also a great way of involving ASD children in a social situation where they are more receptive to learning communication skills while opening up with peers, in a relaxed and happy environment. Endorphin; a neurotransmitter, is released in our body during exercise, which triggers a positive/happy feeling, making ASD children more receptive to learning / acquiring new skills through this mode of intervention.
Since all ASD children are unique, it is important to find the right choice of physical exercise/sport that fits their particular profile/symptoms, biomechanics for this mode of intervention to be effective in improving their pragmatic communication skills and social interaction.
The study aims to research the positive effects of outdoor sports activities on pragmatic language skills development amongst the Autistic children aged 5-7 years in Pakistani population. It will help establish a great mode of therapeutic intervention for developing Pragmatic language skills amongst children with Autism. Once established, this mode of intervention will also assist in creating a platform for much needed community based recreational activities for the Autism families in Pakistan.
- Being tested
- Physical activity protocol/out door sports, Intensive table teaching speech therapy
- Keywords
- outdoor sports, physical activity, communication skills
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity protocol/out door sportsOther
Warm up exercise will be administered for 10 minutes, then one-to-five small group of instruction based activity will be administered for 15 minutes. After this whole group will be engaged in ball exercise and cooperative ball games for 20 minutes. At the end cool down and reward activity will be done with participants for 15v minutes.
Total 1 hour physical activity protocol will be administered twice a week.
Intensive table teaching speech therapyOther
Control group participants will be given speech therapy session based on intensive table teaching for 30 minutes twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Structured physical activity/outdoor sports. | Experimental | Out door sports and structured physical activity protocol will be administered on children with Autism. Receives: Other: Physical activity protocol/out door sports |
| Intensive table teaching control group | Active comparator | Control group will only be exposed to intensive table teaching instead of physical activity protocol. Receives: Other: Intensive table teaching speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Interaction tasks ABLLS-R (Assessment of basic language learning Skills-Revised)
Changes from baseline, It provides a comprehensive review of the social interaction. It has 34 tasks having 0-4 scoring. Minimum score is 0 and maximum score is 134.
It provides a comprehensive review of areas including language, social interaction, self-help, academic and motor skills. The task items within each skill area are arranged from simpler to more complex tasks. Social Interaction comprises of 34 tasks that would be used as a measuring tool in this study.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start20 Oct 2020
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Autistic Disorder of Childhood Onset With Full SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabia Zubair, MS-SLP/T, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593576
- Sponsor's protocol ID
- REC/00807 Saman Javaid
- Status last verified
- Jun 2021
- First submitted
- 13 Oct 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fedotchev AI, Dvoryaninova VV, Velikova SD, Zemlyanaya АА. Modern Technologies in Studying the Mechanisms, Diagnostics, and Treatment of Autism Spectrum Disorders. Современные технологии в медицине. 2019;11(1 (eng)).
Tse CYA, Pang CL, Lee PH. Choosing an Appropriate Physical Exercise to Reduce Stereotypic Behavior in Children with Autism Spectrum Disorders: A Non-randomized Crossover Study. J Autism Dev Disord. 2018 May;48(5):1666-1672. doi: 10.1007/s10803-017-3419-3.
PubMed 29196864Zhao M, Chen S. The Effects of Structured Physical Activity Program on Social Interaction and Communication for Children with Autism. Biomed Res Int. 2018 Jan 15;2018:1825046. doi: 10.1155/2018/1825046. eCollection 2018.
PubMed 29568743DAN YJ, SU LY, LIU YH. Case Study on PE Intervention of the Communicative Behaviors of Autistic Infants [J]. Journal of Tianjin University of Sport. 2006;2. (Article in Chinese)
MA K. Examining the perceived impacts of recreational swimming lessons for children with autism spectrum disorder. International Journal of Aquatic Research and Education. 2019;10(4):6.
Cei A, Franceschi P, Rosci M, Sepio D, Ruscello B. Motor and psychosocial development in children with autism spectrum disorder through soccer. International Journal of Sport Psychology. 2017;48(5):485-507.
Howells K, Sivaratnam C, Lindor E, Hyde C, McGillivray J, Whitehouse A, Rinehart N. Can Participation in a Community Organized Football Program Improve Social, Behavioural Functioning and Communication in Children with Autism Spectrum Disorder? A Pilot Study. J Autism Dev Disord. 2020 Oct;50(10):3714-3727. doi: 10.1007/s10803-020-04423-5.
PubMed 32107700Howells K, Sivaratnam C, May T, Lindor E, McGillivray J, Rinehart N. Efficacy of Group-Based Organised Physical Activity Participation for Social Outcomes in Children with Autism Spectrum Disorder: A Systematic Review and Meta-analysis. J Autism Dev Disord. 2019 Aug;49(8):3290-3308. doi: 10.1007/s10803-019-04050-9.
PubMed 31102193Yu CCW, Wong SWL, Lo FSF, So RCH, Chan DFY. Study protocol: a randomized controlled trial study on the effect of a game-based exercise training program on promoting physical fitness and mental health in children with autism spectrum disorder. BMC Psychiatry. 2018 Feb 27;18(1):56. doi: 10.1186/s12888-018-1635-9.
PubMed 29486750
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Outdoor Sports Activities on Pragmatic Language Skills for Children With Autism in Pakistan.
- ClinicalTrials.gov ID
- NCT04593576
- Acronym / sponsor ID
- REC/00807 Saman Javaid
- Keywords
- outdoor sports, physical activity, communication skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 20 Oct 2020 (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.
To investigate the effects of structured physical exercises/outdoor sports on social interaction/communication skills of children with Autism in Pakistan.
Detailed description
The word Autism is derived from the Latin word "Autos'' which means "self" - immersion in one's own world. Autism is a disorder that manifests itself in early childhood, is disabling in many cases and is characterized by severe deficits in communication, social interaction, speech/language delays, sensory issues, repetitive and stereotyped behavior, limited interests. Autism was first described as a disease, by an American physician; Autism later came to be known as ASD (Autism spectrum Disorder) due to numerous disorders, various combinations of disorders, multiple unknown etiologies, subtypes and dynamics of the evolving disease. Autism is on the rise with a prevalence rate of 1-2% of infant population. In 2014, the 67th World Health assembly passed a resolution for "Comprehensive and Co-ordinated efforts for the management of the Autism Spectrum Disorders "which was supported by 60 countries, showing the relevance of the pathology. Research on Autism has increased recently, and publications have nearly doubled in the last 5 years, as this spectrum of disorders continues to baffle doctors and scientists and has no cure till now, but can only be managed.
Benefits of physical exercises/sports have been researched, discussed and documented in great detail in the past. But the purpose of this research study is to explore the (Pragmatic communication and social interaction) benefits of specific sports/physical exercises for children aged 5-7 years who are on the spectrum, children with ASD diagnosis. Psychiatrists maintain that certain brain connections develop in ASD children if they regularly indulge / participate in particular sports like athletics (running, jogging, other track events), hiking (exposure to nature), swimming, cycling, horse- back riding, team sports like; basketball, soccer etc. The co-ordination between right and left sides of the body is more important in these sports. Team sports are also a great way of involving ASD children in a social situation where they are more receptive to learning communication skills while opening up with peers, in a relaxed and happy environment. Endorphin; a neurotransmitter, is released in our body during exercise, which triggers a positive/happy feeling, making ASD children more receptive to learning / acquiring new skills through this mode of intervention.
Since all ASD children are unique, it is important to find the right choice of physical exercise/sport that fits their particular profile/symptoms, biomechanics for this mode of intervention to be effective in improving their pragmatic communication skills and social interaction.
The study aims to research the positive effects of outdoor sports activities on pragmatic language skills development amongst the Autistic children aged 5-7 years in Pakistani population. It will help establish a great mode of therapeutic intervention for developing Pragmatic language skills amongst children with Autism. Once established, this mode of intervention will also assist in creating a platform for much needed community based recreational activities for the Autism families in Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured physical activity/outdoor sports. | Experimental | Other: Physical activity protocol/out door sportsOut door sports and structured physical activity protocol will be administered on children with Autism. |
| Intensive table teaching control group | Active comparator | Other: Intensive table teaching speech therapyControl group will only be exposed to intensive table teaching instead of physical activity protocol. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female students with Autism (mild-moderate)
- Participants will be screened on short sensory profile, fulfilling the criteria of typical performance and probable difference will be included.
Key exclusion criteria (1 listed)
- individuals with Autism along with any comorbid condition.
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 |
|---|---|---|
| Physical activity protocol/out door sportsWarm up exercise will be administered for 10 minutes, then one-to-five small group of instruction based activity will be administered for 15 minutes. After this whole group will be engaged in ball exercise and cooperative ball games for 20 minutes. At the end cool down and reward activity will be done with participants for 15v minutes. Total 1 hour physical activity protocol will be administered twice a week. | Other | Structured physical activity/outdoor sports. |
| Intensive table teaching speech therapyControl group participants will be given speech therapy session based on intensive table teaching for 30 minutes twice a week. | Other | Intensive table teaching control group |
Primary outcome
Social Interaction tasks ABLLS-R (Assessment of basic language learning Skills-Revised)
Time frame: 15 days
Changes from baseline, It provides a comprehensive review of the social interaction. It has 34 tasks having 0-4 scoring. Minimum score is 0 and maximum score is 134. It provides a comprehensive review of areas including language, social interaction, self-help, academic and motor skills. The task items within each skill area are arranged from simpler to more complex tasks. Social Interaction comprises of 34 tasks that would be used as a measuring tool in this study.
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 29 Jun 2021.
- BackgroundFedotchev AI, Dvoryaninova VV, Velikova SD, Zemlyanaya АА. Modern Technologies in Studying the Mechanisms, Diagnostics, and Treatment of Autism Spectrum Disorders. Современные технологии в медицине. 2019;11(1 (eng)).
- Background: PubMed 29196864Tse CYA, Pang CL, Lee PH. Choosing an Appropriate Physical Exercise to Reduce Stereotypic Behavior in Children with Autism Spectrum Disorders: A Non-randomized Crossover Study. J Autism Dev Disord. 2018 May;48(5):1666-1672. doi: 10.1007/s10803-017-3419-3.
- Background: PubMed 29568743Zhao M, Chen S. The Effects of Structured Physical Activity Program on Social Interaction and Communication for Children with Autism. Biomed Res Int. 2018 Jan 15;2018:1825046. doi: 10.1155/2018/1825046. eCollection 2018.
- BackgroundDAN YJ, SU LY, LIU YH. Case Study on PE Intervention of the Communicative Behaviors of Autistic Infants [J]. Journal of Tianjin University of Sport. 2006;2. (Article in Chinese)
- BackgroundMA K. Examining the perceived impacts of recreational swimming lessons for children with autism spectrum disorder. International Journal of Aquatic Research and Education. 2019;10(4):6.
- BackgroundCei A, Franceschi P, Rosci M, Sepio D, Ruscello B. Motor and psychosocial development in children with autism spectrum disorder through soccer. International Journal of Sport Psychology. 2017;48(5):485-507.
- Background: PubMed 32107700Howells K, Sivaratnam C, Lindor E, Hyde C, McGillivray J, Whitehouse A, Rinehart N. Can Participation in a Community Organized Football Program Improve Social, Behavioural Functioning and Communication in Children with Autism Spectrum Disorder? A Pilot Study. J Autism Dev Disord. 2020 Oct;50(10):3714-3727. doi: 10.1007/s10803-020-04423-5.
- Background: PubMed 31102193Howells K, Sivaratnam C, May T, Lindor E, McGillivray J, Rinehart N. Efficacy of Group-Based Organised Physical Activity Participation for Social Outcomes in Children with Autism Spectrum Disorder: A Systematic Review and Meta-analysis. J Autism Dev Disord. 2019 Aug;49(8):3290-3308. doi: 10.1007/s10803-019-04050-9.
- Background: PubMed 29486750Yu CCW, Wong SWL, Lo FSF, So RCH, Chan DFY. Study protocol: a randomized controlled trial study on the effect of a game-based exercise training program on promoting physical fitness and mental health in children with autism spectrum disorder. BMC Psychiatry. 2018 Feb 27;18(1):56. doi: 10.1186/s12888-018-1635-9.
- Individual participant dataSharing planned: No
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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.
Rabia Zubair, MS-SLP/T principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity protocol/out door sports and Intensive table teaching speech therapy in people with Autistic Disorder of Childhood Onset With Full Syndrome, run by Riphah International University 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 2 inclusion and 1 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 29 Jun 2021. 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?
Social Interaction tasks ABLLS-R (Assessment of basic language learning Skills-Revised) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593576, which also lists 9 linked publications.
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 29 Jun 2021.