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.
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.
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.
- Conditions
- 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.
- 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. .
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 group | Role | What they receive |
|---|---|---|
| Bal-A-Vis-X training Group | Experimental | Bal-A-Vis-X training Group Receives: Other: Bal-A-Vis-X training; Other: Aerobic Training Group |
| Aerobic Training Group | Active comparator | Aerobic 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.
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
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
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.
- First posted19 Aug 2021
- Study start11 Nov 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
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.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, MS-NMPT*, Principal investigator, Riphah international university.pakistan
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Rhythmic Balance Auditory Vision Training (Bal-A-Vis-X) and Aerobic Training in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05013528
- Acronym / sponsor ID
- Bal-A-Vis-X / REC/00826 Mahnoor Zia
- Conditions
- Autism Spectrum Disorder
- Keywords
- Aerobic Training, Autism Spectrum Disorder, Bal-A-Vis-X, Balance Auditory Vision Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 19 Aug 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bal-A-Vis-X training Group | Experimental | Other: Bal-A-Vis-X training, Other: Aerobic Training GroupBal-A-Vis-X training Group |
| Aerobic Training Group | Active comparator | Other: Bal-A-Vis-X training, Other: Aerobic Training GroupAerobic Training Group |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Give Consent to take part
- Children diagnosed with ASD by psychologist
Key exclusion criteria (4 listed)
- Having co-morbidities like schizophrenia and developmental delay
- Showing aggressive behavior
- Having disease of cardiovascular or respiratory system
- Children with auditory and visual 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 |
|---|---|---|
| Bal-A-Vis-X trainingAlso: Group ABal-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. . | Other | Aerobic Training Group, Bal-A-Vis-X training Group |
| Aerobic Training GroupAlso: Group BAerobic 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 | Other | Aerobic Training Group, Bal-A-Vis-X training Group |
Primary outcome
Bruininks- Oseretsky Test of Motor Proficiency-2 (BOT-2)
Time frame: 6 weeks
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
Time frame: 6 weeks
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
Time frame: 6 weeks
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.
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 18 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Aruba Saeed, MS-NMPT* principal investigator
Riphah international university.pakistan
1 site in 1 country: see every site and its status.
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.