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Autism Spectrum DisorderBal-A-Vis-XNCT05013528

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

A study testing Bal-A-Vis-X training and Aerobic Training Group in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Bal-A-Vis-X training and Aerobic Training Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
11 Nov 2021to 30 Jan 2022
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 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Child Dream Center

    Faisalabad, Punjab Province, 38000

Other trials in Pakistan

About this study

Official title: Comparative Effect of Rhythmic Balance Auditory Vision Training (Bal-A-Vis-X) and Aerobic Training in Children With Autism Spectrum Disorder

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.

Read the 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.

Being tested
Bal-A-Vis-X training, Aerobic Training Group
Keywords
Aerobic Training, Autism Spectrum Disorder, Bal-A-Vis-X, Balance Auditory Vision Training
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.

  • Bal-A-Vis-X trainingOther

    Also called Group A

    Bal-A-Vis-X training Performed thrice a week for 10 minutes after baseline assessment Standard Physical therapy treatment along with following exercises.

    1. ball Rectangle
    2. ball rectangle and 2 ball drop/pass/catch two-foot jumping forward, tandem walking on ground and tandem walking on the balance beam. .
  • Aerobic Training GroupOther

    Also called Group B

    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

Study groups in NCT05013528
Study groupRoleWhat they receive
Bal-A-Vis-X training GroupExperimentalBal-A-Vis-X training Group
Receives: Other: Bal-A-Vis-X training; Other: Aerobic Training Group
Aerobic Training GroupActive comparatorAerobic Training Group
Receives: Other: Bal-A-Vis-X training; Other: Aerobic Training Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2021
  2. Study start11 Nov 2021
  3. Primary completion30 Jan 2022
  4. Study completion30 Jan 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05013528
Sponsor's protocol ID
REC/00826 Mahnoor Zia
Acronym
Bal-A-Vis-X
Status last verified
Apr 2022
First submitted
16 Aug 2021
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bal-A-Vis-X training and Aerobic Training Group in people with Autism Spectrum Disorder, run by Riphah International University 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 2 inclusion and 4 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 18 Apr 2022. 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?

Bruininks- Oseretsky Test of Motor Proficiency-2 (BOT-2) (time frame: 6 weeks). The study lists 3 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 18 Apr 2022.

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