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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05986760
Other study ID # RiphahIU-ASAD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 27, 2022
Est. completion date May 27, 2023

Study information

Verified date August 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It was a Randomized Clinical Trial.Data will be collected from Life care rehabilitation and special child facility.The study was completed within 6 months after approval of synopsis.The calculated sample size, through WHO sample size calculator, using Bruininks- Oseretsky test's mean and standard deviation (Mean Dynamic Balance) as outcome measure was 20 in each group. After adding 10% dropout the sample size will be 20+4=24 in each group; hence, overall sample size n= 20. Age range 5-12 years. Children with diagnosed Autism and age ranges between 5-12 will be included in the study.Convenient Sampling Technique was used to collect the data.There was two groups.In Group A SPARK therapy will be provided and in group 2 fundamental motor skill training will be provided. To assess the social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) and for motor skills Bruininkse Oseretsky test of motor proficiency (BOTMP) was used.


Description:

Autism Spectrum Disorder affects the social communication and fundamental motor skills of children. The current study will evaluate the effects of sports play and active recreation for kids (SPARK) versus fundamental motor skill training on social and motor skills in children with Autism spectrum disorder. It was a Randomized Clinical Trial.Data will be collected from Life care rehabilitation and special child facility.The study was completed within 6 months after approval of synopsis.The calculated sample size, through WHO sample size calculator, using Bruininks- Oseretsky test's mean and standard deviation (Mean Dynamic Balance) as outcome measure was 20 in each group. After adding 10% dropout the sample size will be 20+4=24 in each group; hence, overall sample size n= 20. Age range 5-12 years. Children with diagnosed Autism and age ranges between 5-12 will be included in the study.Convenient Sampling Technique was used to collect the data.There was two groups.In Group A SPARK therapy will be provided and in group 2 fundamental motor skill training will be provided. To assess the social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) and for motor skills Bruininkse Oseretsky test of motor proficiency (BOTMP) was used. Analysis was carried out on SPSS version 27.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 27, 2023
Est. primary completion date May 27, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 9 Years
Eligibility Inclusion Criteria: - Age range 5-9 years (11) • Diagnosed with an Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, - Pervasive developmental disorder-not otherwise specified - Asperger's disorder based on clinical judgment and supported by the Autism Diagnostic Observation Schedule - Having moderate or greater behavioral problems as measured by a pretreatment score of >15 on the Aberrant Behavior Checklist-Irritability subscale - Ability to follow directions and perform requested motor skill proficiency and executive function measures Exclusion Criteria: - Participants with diagnosed cognitive impairments - Unable to walk independently - History of traumatic injury - History of previous surgery history - Inability to understand the procedure and unwillingness to participate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SPARK
Functional Motor training

Locations

Country Name City State
Pakistan Riphah Rehabilitation Center Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
khadija liaquat

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
Primary Motor Skills: Bruininkse Oseretsky test of motor proficiency (BOTMP) Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
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