NCT04593576

Brief Summary

To investigate the effects of structured physical exercises/outdoor sports on social interaction/communication skills of children with Autism in Pakistan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

October 13, 2020

Last Update Submit

June 26, 2021

Conditions

Keywords

outdoor sportsphysical activitycommunication skills

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 days

Study Arms (2)

Structured physical activity/outdoor sports.

EXPERIMENTAL

Out door sports and structured physical activity protocol will be administered on children with Autism.

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.

Other: Intensive table teaching speech therapy

Interventions

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.

Structured physical activity/outdoor sports.

Control group participants will be given speech therapy session based on intensive table teaching for 30 minutes twice a week.

Intensive table teaching control group

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • individuals with Autism along with any comorbid condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profiles

Rawalpindi, 46000, Pakistan

Location

Related Publications (9)

  • 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)).

    BACKGROUND
  • 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.

    PMID: 29196864BACKGROUND
  • 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.

    PMID: 29568743BACKGROUND
  • 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)

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32107700BACKGROUND
  • 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.

    PMID: 31102193BACKGROUND
  • 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.

    PMID: 29486750BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rabia Zubair, MS-SLP/T

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

October 20, 2020

Primary Completion

April 10, 2021

Study Completion

April 10, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations