NCT05986760

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

June 15, 2023

Last Update Submit

August 8, 2023

Conditions

Keywords

Autism Spectrum DisorderMotor Skill

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

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).

Behavioral: SPARK

Interventions

SPARKBEHAVIORAL

Functional Motor training

Also known as: FMS
Fundamental Motor trainingSPARK

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

June 15, 2023

First Posted

August 14, 2023

Study Start

December 27, 2022

Primary Completion

May 27, 2023

Study Completion

May 27, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations