Autism Spectrum DisorderNCT05986760
Comparsion of SPARK and Fundamental Motor Training
A study testing SPARK in people with Autism Spectrum Disorder, run by khadija liaquat at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- SPARK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Dec 2022to 27 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- SPARK
- Keywords
- Autism Spectrum Disorder, Motor Skill
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARKBehavioural
Also called FMS
Functional Motor training
| Study group | Role | What they receive |
|---|---|---|
| SPARK | Experimental | 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. Receives: Behavioral: SPARK |
| Fundamental Motor training | Experimental | 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). Receives: Behavioral: SPARK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social skills
Gilliam Autism Rating Scale-Second Edition (GARS-2)
Measured: Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
Motor Skills:
Bruininkse Oseretsky test of motor proficiency (BOTMP)
Measured: Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start27 Dec 2022
- Primary completion27 May 2023
- Study completion27 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- khadija liaquat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, khadija liaquat, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986760
- Sponsor's protocol ID
- RiphahIU-ASAD
- Status last verified
- Aug 2023
- First submitted
- 15 Jun 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05986760
- Acronym / sponsor ID
- RiphahIU-ASAD
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Motor Skill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- khadija liaquatUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 27 May 2023 (actual)
- Study completion
- 27 May 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SPARK | Experimental | Behavioral: SPARKThe 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. |
| Fundamental Motor training | Experimental | Behavioral: SPARKIn 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). |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Participants with diagnosed cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARKAlso: FMSFunctional Motor training | Behavioural | Fundamental Motor training, SPARK |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK in people with Autism Spectrum Disorder, run by khadija liaquat at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social skills (time frame: Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.