Impact of Sports Activity on Pragmatic Skills of Children
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04593576 |
|
Recruitment Status :
Completed
First Posted : October 20, 2020
Last Update Posted : June 29, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Autistic Disorder of Childhood Onset With Full Syndrome | Other: Physical activity protocol/out door sports Other: Intensive table teaching speech therapy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Outdoor Sports Activities on Pragmatic Language Skills for Children With Autism in Pakistan. |
| Actual Study Start Date : | October 20, 2020 |
| Actual Primary Completion Date : | April 10, 2021 |
| Actual Study Completion Date : | April 10, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Structured physical activity/outdoor sports.
Out door sports and structured physical activity protocol will be administered on children with Autism.
|
Other: Physical activity protocol/out door sports
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. |
|
Active Comparator: Intensive table teaching control group
Control group will only be exposed to intensive table teaching instead of physical activity protocol.
|
Other: Intensive table teaching speech therapy
Control group participants will be given speech therapy session based on intensive table teaching for 30 minutes twice a week. |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 5 Years to 7 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593576
| Pakistan | |
| Profiles | |
| Rawalpindi, Pakistan, 46000 | |
| Principal Investigator: | Rabia Zubair, MS-SLP/T | Riphah International University |
| Responsible Party: | Riphah International University |
| ClinicalTrials.gov Identifier: | NCT04593576 |
| Other Study ID Numbers: |
REC/00807 Saman Javaid |
| First Posted: | October 20, 2020 Key Record Dates |
| Last Update Posted: | June 29, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
outdoor sports physical activity communication skills |
|
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |