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Balance Auditory Vision Training (Bal-A-Vis-X) and Aerobic Training in Children With Autism Spectrum Disorder (Bal-A-Vis-X)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Bal-A-Vis-X training
Aerobic Training Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Aerobic Training, Autism Spectrum Disorder, Bal-A-Vis-X, Balance Auditory Vision Training

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Give Consent to take part
  • Children diagnosed with ASD by psychologist

Exclusion Criteria:

  • Having co-morbidities like schizophrenia and developmental delay
  • Showing aggressive behavior
  • Having disease of cardiovascular or respiratory system
  • Children with auditory and visual impairments

Sites / Locations

  • Child Dream Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bal-A-Vis-X training Group

Aerobic Training Group

Arm Description

Bal-A-Vis-X training Group

Aerobic Training Group

Outcomes

Primary Outcome Measures

Bruininks- Oseretsky Test of Motor Proficiency-2 (BOT-2)
Changes are measured from baseline. This test is used to measure 1. Fine Manual Control: Fine Motor Precision, Fine Motor Integration; 2. Manual Coordination: Manual Dexterity, Upper-Limb Coordination; 3. Body Coordination: Bilateral Coordination, Balance; 4. Strength and Agility: Running Speed and Agility.
Childhood Executive Functioning Inventory
Changes are measured from baseline. The Childhood Executive Functioning Inventory (CHEXI) is a rating instruments for parents and teachers that was developed in 2008 for measuring executive functioning in children.
Color Trail Test
Changes are measured from baseline. The Color Trails Test (CTT) is a language-free version of the Trail Making Test (TMT). The CTT is comprised of two tasks. The CTT manual reports that it takes 3-8 minutes to complete the CTT.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
April 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05013528
Brief Title
Balance Auditory Vision Training (Bal-A-Vis-X) and Aerobic Training in Children With Autism Spectrum Disorder
Acronym
Bal-A-Vis-X
Official Title
Comparative Effect of Rhythmic Balance Auditory Vision Training (Bal-A-Vis-X) and Aerobic Training in Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
the aim of this study is to compare the effects of Rhythmic Balance, Auditory, and Vision Exercises and Aerobic training in children with Autism Spectrum Disorder.
Detailed Description
Autism is an Umbrella term for a lifelong neuropsychiatric disorder which falls into the category of pervasive developmental disabilities. Autistic Spectrum Disorder (ASD) is a syndrome that often develops in early childhood, characterized by impairment of speech, the problems encountered in communication with the environment, display of certain skills, and developmental retardation in almost all cognitive functions. Autism is a "spectrum disorder'' ranging in severity in every individual. Symptoms of autistic disorder arise during the initial 2 years of life. Problem with language advancement and social interaction are the major concerns reported by parents by 2 years of age. Evidence has recommended that motor disability is quite possibly the most predictable markers, close by socio communicative challenges, for mental imbalance range issue such as autism spectrum disorder. These motor anomalies could have basic ramifications for resulting psychological and social turn of events. In any case, this territory of improvement is especially under examined in the mental imbalance related setting, and early mediation programs normally center around the core symptoms of the Autism disorder. Although the confined nature of the literature prevents researchers from drawing definitive conclusions, the outcomes from the research mentioned in this study verified probably huge upgrades in the motor skills of autistic children after the physical therapy interventions. Physical activity plays important role in improving cognition, enhancing executive functions of children to perform daily life activities in children with Autism Spectrum disorders and mental retardation A case report organized and ratified by Rehabilitation department of the University of Lowa, to determine the efficacy of Rhythmic Balance, Auditory, and Vision Exercises as an adjunctive intervention to conventional physical therapy protocol administered in child with Autism and ADHD.A 6 year old child diagnosed with ADHD and Autism was recruited in the study with major recognized difficulties in strength and agility. A 9 week protocol of Bal-A-Vis-X program involving a multi system approach was incorporated in addition to basic pediatric rehabilitation protocol. A notable improvement in child gross motor functions was observed as measured by Bruininks-Oseretsky Test of Motor Proficiency, Second Edition after the intervention. A pilot study was conducted to ascertain the effect of Rhythmic Balance, Auditory, and Vision Exercises on selective attention of the students. A 10-minutes of Bal-A-Vis-X training twice per week for eight weeks was administered. Significant gains in focused attention and concentration was reported and measured after the intervention in students. A research investigating the effect of Bal-A-Vis-X protocol on elementary school students of special education department was carried on. A positive effect of Bal-A-Vis-X training is observed in on task attention during academic activities in children with ADHD , Autism and other mentally disabled individuals The past research records are evident that therapists have determined the individual effect of Aerobic training and Rhythmic Balance, Auditory, and Vision Exercises training for rehabilitation of ASD children. The evidence for implementation of two protocols for rehabilitation of ASD children is sparse. So the aim of this study is to compare the effects of Rhythmic Balance, Auditory, and Vision Exercises and Aerobic training in children with Autism Spectrum Disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Aerobic Training, Autism Spectrum Disorder, Bal-A-Vis-X, Balance Auditory Vision Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Neither subjects nor the investigator who is assessing the patient are aware of the treatment assignment until the end of the study
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bal-A-Vis-X training Group
Arm Type
Experimental
Arm Description
Bal-A-Vis-X training Group
Arm Title
Aerobic Training Group
Arm Type
Active Comparator
Arm Description
Aerobic Training Group
Intervention Type
Other
Intervention Name(s)
Bal-A-Vis-X training
Other Intervention Name(s)
Group A
Intervention Description
Bal-A-Vis-X training Performed thrice a week for 10 minutes after baseline assessment Standard Physical therapy treatment along with following exercises. ball Rectangle ball rectangle and 2 ball drop/pass/catch two-foot jumping forward, tandem walking on ground and tandem walking on the balance beam. .
Intervention Type
Other
Intervention Name(s)
Aerobic Training Group
Other Intervention Name(s)
Group B
Intervention Description
Aerobic training group performed exercises thrice a week for 10 minutes after baseline assessment. Standard Physical therapy treatment along with aerobic training as Running is performed
Primary Outcome Measure Information:
Title
Bruininks- Oseretsky Test of Motor Proficiency-2 (BOT-2)
Description
Changes are measured from baseline. This test is used to measure 1. Fine Manual Control: Fine Motor Precision, Fine Motor Integration; 2. Manual Coordination: Manual Dexterity, Upper-Limb Coordination; 3. Body Coordination: Bilateral Coordination, Balance; 4. Strength and Agility: Running Speed and Agility.
Time Frame
6 weeks
Title
Childhood Executive Functioning Inventory
Description
Changes are measured from baseline. The Childhood Executive Functioning Inventory (CHEXI) is a rating instruments for parents and teachers that was developed in 2008 for measuring executive functioning in children.
Time Frame
6 weeks
Title
Color Trail Test
Description
Changes are measured from baseline. The Color Trails Test (CTT) is a language-free version of the Trail Making Test (TMT). The CTT is comprised of two tasks. The CTT manual reports that it takes 3-8 minutes to complete the CTT.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Give Consent to take part Children diagnosed with ASD by psychologist Exclusion Criteria: Having co-morbidities like schizophrenia and developmental delay Showing aggressive behavior Having disease of cardiovascular or respiratory system Children with auditory and visual impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aruba Saeed, MS-NMPT*
Organizational Affiliation
Riphah international university.pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Dream Center
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Balance Auditory Vision Training (Bal-A-Vis-X) and Aerobic Training in Children With Autism Spectrum Disorder

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