- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05986760
Comparsion of SPARK and Fundamental Motor Training
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah Rehabilitation Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SPARK
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.
|
Functional Motor training
Other Names:
|
|
Experimental: Fundamental Motor training
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).
|
Functional Motor training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social skills
Time Frame: Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
|
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
|
|
Motor Skills:
Time Frame: Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
|
Bruininkse Oseretsky test of motor proficiency (BOTMP)
|
Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU-ASAD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Greater Atlanta Integrative PediatricsRecruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Adia Med of Winter Park LLCRecruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Blinklab LimitedRecruitingAutism Spectrum Disorder | Autism | Neurodevelopmental Conditions | Autism Spectrum Disorder (ASD)United States
-
Poznan University of Physical EducationNational Science Centre, PolandCompletedAutism Spectrum Disorder | ASD | Autism Spectrum Disorder High-Functioning | Autism SpectrumPoland
-
National Cheng-Kung University HospitalCompletedAutism Spectrum Disorder (ASD) | Autism Spectrum Disorder High-FunctioningTaiwan
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
Stanford UniversityCalifornia Department of Developmental ServicesActive, not recruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
Clinical Trials on SPARK
-
Radicle ScienceCompletedSexual Function | Sexual SatisfactionUnited States
-
The Hospital for Sick ChildrenNot yet recruiting
-
The Hospital for Sick ChildrenCompleted
-
Johns Hopkins UniversityRecruitingPain | Aging | Depressive SymptomsUnited States
-
Karolinska InstitutetLinkoeping University; Region ÖstergötlandRecruitingGestational Diabetes MellitusSweden
-
Radicle ScienceCompletedSexual Function | Sexual SatisfactionUnited States
-
Spark Neuro Inc.Completed
-
North Shore Therapeutics, Inc.University of Pennsylvania; Northwell HealthNot yet recruitingSchizophrenia / Schizoaffective DisorderUnited States
-
University of WashingtonNational Institute of Mental Health (NIMH)Completed
-
Duke UniversityNational Cancer Institute (NCI)CompletedFertility Issues | Childhood CancerUnited States