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Comparsion of SPARK and Fundamental Motor Training

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
SPARK
Sponsored by
khadija liaquat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Motor Skill

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SPARK

Fundamental Motor training

Arm Description

The SPARK is an evidence based plan designed to improve health-related well-being and to maintain the positive socialization and enjoyment of physical activities or academic achievements.(4) The SPARK discipline is in line with NASPE (National Association of Sport and PE) guidelines. A standard SPARK lesson will be delivered in two parts: a health fitness activity and a skill-fitness activity. In the health fitness activity part, there will be 13 activities that include aerobic dance, running games and jump ropes. In this part, the main focus will be on developing cardiovascular endurance and promotion by modifying the intensity, duration and complexity of the activities. The activities will be mostly aimed to develop abdominal and upper body strength.

In terms of motor development, fundamental motor skills (FMS, e.g., locomotor and object manipulation)-such as running, jumping, throwing, and kicking-are considered the essential building blocks for further, more complex gross motor movement. (24) There will be 13 FMS activities including; running, jumping, Gallop, hopping, side gliding, skipping, leaping, catching, stationary dribbles, kicking, striking a stationary ball, overarm throw and underarm throw. FMS group will receive 30 sessions for 10 weeks (3 sessions per week, 60 min per session including CPT).

Outcomes

Primary Outcome Measures

Social skills
Gilliam Autism Rating Scale-Second Edition (GARS-2)
Motor Skills:
Bruininkse Oseretsky test of motor proficiency (BOTMP)

Secondary Outcome Measures

Full Information

First Posted
June 15, 2023
Last Updated
August 8, 2023
Sponsor
khadija liaquat
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1. Study Identification

Unique Protocol Identification Number
NCT05986760
Brief Title
Comparsion of SPARK and Fundamental Motor Training
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
May 27, 2023 (Actual)
Study Completion Date
May 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
khadija liaquat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Motor Skill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The SPARK is an evidence based plan designed to improve health-related well-being and to maintain the positive socialization and enjoyment of physical activities or academic achievements.(4) The SPARK discipline is in line with NASPE (National Association of Sport and PE) guidelines. A standard SPARK lesson will be delivered in two parts: a health fitness activity and a skill-fitness activity. In the health fitness activity part, there will be 13 activities that include aerobic dance, running games and jump ropes. In this part, the main focus will be on developing cardiovascular endurance and promotion by modifying the intensity, duration and complexity of the activities.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPARK
Arm Type
Experimental
Arm Description
The SPARK is an evidence based plan designed to improve health-related well-being and to maintain the positive socialization and enjoyment of physical activities or academic achievements.(4) The SPARK discipline is in line with NASPE (National Association of Sport and PE) guidelines. A standard SPARK lesson will be delivered in two parts: a health fitness activity and a skill-fitness activity. In the health fitness activity part, there will be 13 activities that include aerobic dance, running games and jump ropes. In this part, the main focus will be on developing cardiovascular endurance and promotion by modifying the intensity, duration and complexity of the activities. The activities will be mostly aimed to develop abdominal and upper body strength.
Arm Title
Fundamental Motor training
Arm Type
Experimental
Arm Description
In terms of motor development, fundamental motor skills (FMS, e.g., locomotor and object manipulation)-such as running, jumping, throwing, and kicking-are considered the essential building blocks for further, more complex gross motor movement. (24) There will be 13 FMS activities including; running, jumping, Gallop, hopping, side gliding, skipping, leaping, catching, stationary dribbles, kicking, striking a stationary ball, overarm throw and underarm throw. FMS group will receive 30 sessions for 10 weeks (3 sessions per week, 60 min per session including CPT).
Intervention Type
Behavioral
Intervention Name(s)
SPARK
Other Intervention Name(s)
FMS
Intervention Description
Functional Motor training
Primary Outcome Measure Information:
Title
Social skills
Description
Gilliam Autism Rating Scale-Second Edition (GARS-2)
Time Frame
Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
Title
Motor Skills:
Description
Bruininkse Oseretsky test of motor proficiency (BOTMP)
Time Frame
Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparsion of SPARK and Fundamental Motor Training

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