Impact of Sports Activity on Pragmatic Skills of Children
Primary Purpose
Autistic Disorder of Childhood Onset With Full Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Physical activity protocol/out door sports
Intensive table teaching speech therapy
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder of Childhood Onset With Full Syndrome focused on measuring outdoor sports, physical activity, communication skills
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- individuals with Autism along with any comorbid condition.
Sites / Locations
- Profiles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Structured physical activity/outdoor sports.
Intensive table teaching control group
Arm Description
Out door sports and structured physical activity protocol will be administered on children with Autism.
Control group will only be exposed to intensive table teaching instead of physical activity protocol.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04593576
First Posted
October 13, 2020
Last Updated
June 26, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04593576
Brief Title
Impact of Sports Activity on Pragmatic Skills of Children
Official Title
Effects of Outdoor Sports Activities on Pragmatic Language Skills for Children With Autism in Pakistan.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
April 10, 2021 (Actual)
Study Completion Date
April 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder of Childhood Onset With Full Syndrome
Keywords
outdoor sports, physical activity, communication skills
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Structured physical activity/outdoor sports.
Arm Type
Experimental
Arm Description
Out door sports and structured physical activity protocol will be administered on children with Autism.
Arm Title
Intensive table teaching control group
Arm Type
Active Comparator
Arm Description
Control group will only be exposed to intensive table teaching instead of physical activity protocol.
Intervention Type
Other
Intervention Name(s)
Physical activity protocol/out door sports
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intensive table teaching speech therapy
Intervention Description
Control group participants will be given speech therapy session based on intensive table teaching for 30 minutes twice a week.
Primary Outcome Measure Information:
Title
Social Interaction tasks ABLLS-R (Assessment of basic language learning Skills-Revised)
Description
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.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
individuals with Autism along with any comorbid condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Zubair, MS-SLP/T
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profiles
City
Rawalpindi
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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)).
Results Reference
background
PubMed Identifier
29196864
Citation
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.
Results Reference
background
PubMed Identifier
29568743
Citation
Zhao 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.
Results Reference
background
Citation
DAN 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)
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
32107700
Citation
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.
Results Reference
background
PubMed Identifier
31102193
Citation
Howells 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.
Results Reference
background
PubMed Identifier
29486750
Citation
Yu 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.
Results Reference
background
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Impact of Sports Activity on Pragmatic Skills of Children
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