Autism Spectrum DisorderNCT06308315
Effects of Rhythmic Balance Auditory Vision Training And Strength Training With Autism Spectrum Disorder.
A study testing Rhythmic balance visual auditory exercise + Routine physical therapy and Strength Training + Routine Physical Therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
Autism, a complex neurodevelopmental disorder that is marked by limited interests, and challenges in communication and social interactions and problem includes difficulties in understanding and responding to social cues, repetitive behaviors, intense focus on specific interests, and challenges with verbal and… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Rhythmic balance visual auditory exercise + Routine physical therapy and Strength Training + Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2024to 30 Sep 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range between 6 and 12 years.
- Rating Scale (CARS) with scores ranging from 30 to 36.
- Confirmation of the diagnosis of autism by a psychiatrist based on Diagnostic and Statistical manual of Mental Disorders.
- Physical and cognitive ability
Who cannot join
- Children with history of auditory, visual, or respiratory deficits, or fixed deformities of the extremities.
- Medical contraindications such as orthopedic or acute conditions that hinder participation in the exercise program.
- History of psychotropic medication within the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54660
About this study
Official title: Effects of Rhythmic Balance Auditory Vision Training And Strength Training On Motor Function And Cognition In Children With Autism Spectrum Disorder.
Autism, a complex neurodevelopmental disorder that is marked by limited interests, and challenges in communication and social interactions and problem includes difficulties in understanding and responding to social cues, repetitive behaviors, intense focus on specific interests, and challenges with verbal and nonverbal communication. Rhythmic Balance Auditory Vision Training (RBAVT) a therapeutic approach which helps in improving coordination and balance in individuals with various neurological conditions. Strength training enhance physical health and muscle development. Thus, the purpose of this study is to compare the effects of rhythmic balance auditory vision training and strength training on motor function and cognition in children with autism spectrum disorder.
Read the detailed description
This randomized clinical trial will be conducted in Autism center Lahore. Sample of 76 patients will be recruited in this trial by using the convenience sampling technique. Participants will be randomly allocated in two groups using lottery method. Group A will receive Rhythmic balance visual auditory exercise. Group B will receive strength training exercises. Both groups will receive routine physical therapy as baseline treatment. All the participants will receive 3 sessions per week for 12 weeks.Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) will be used assessment tool to measure fine and gross motor skills and Wisconsin Card Sorting Test (WCST) will be assessment tool that evaluates cognitive flexibility and problem-solving abilities.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Rhythmic balance visual auditory exercise + Routine physical therapy, Strength Training + Routine Physical Therapy
- Keywords
- Autism, Cognition, Motor function, Strength training
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic balance visual auditory exercise + Routine physical therapyOther
5 minute warm-up activities.
Bal-A-Vis-X training includes:
- Ball Rectangle; A and B hold one ball in each hand, simultaneously bounce right balls to patient left hand; while balls bounce, clap left balls on right hand; catch patient ball with left hand; continue pattern. Bounces must be simultaneous. (10 minutes)
- Ball rectangle in which one hand has to toss a ball to a partner and the other hand catch an incoming bag from the partner and 2 ball drop/pass/catch, two-foot jumping forward, tandem walking on ground. (10 minutes)
Routine Physical therapy treatment includes:
Range of Motion exercises, Stretching, Strength, balance training for 15 minutes
5 minute cool-down activities.
Strength Training + Routine Physical TherapyOther
The expert managed sessions based on:
5 minute warm-up activities. 5 minute cool-down activities. Strength training includes 5 tasks for 20 minutes
- core strengthening,
- upper and lower limbs strength in both static positions as well as with dynamic movements
- standing long jump,
- knee push-ups,
- sit-ups
Routine Physical therapy treatment will be given for 15 minutes.
It includes:
Range of Motion exercises, Stretching, Strength, balance training.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Rhythmic Training+ Routine Physical therapy) | Experimental | Rhythmic balance auditory vision training will be given thrice a week for 8 weeks. it is a 45 minute training program that consist of:
1. 5 minute warm up activities (arm swings).
2. Bal-A-Vis-X training thrice a week for 20 minutes.
3. 5-minute cool down activities.
Routine Physical therapy treatment for 15 minutes Receives: Other: Rhythmic balance visual auditory exercise + Routine physical therapy |
| Group B (Strength Training+ Routine Physical Therapy) | Experimental | Strength training Program will be performed thrice a week for 8 weeks. session of 45 minute will be given to the patient. The expert managed sessions based on:
10-min warm-up activities, 25-min basic exercise 10- min cool-down activities. Receives: Other: Strength Training + Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) is a widely used assessment tool to measure fine and gross motor skills in individuals aged 4 to 20. It evaluates various aspects of motor proficiency, including running speed, balance, coordination, and fine motor control. The test helps identify motor skill strengths and weaknesses to aid in intervention and treatment planning. The BOTMP test is a valid assessment tool with 8 subscales (53 sections) for evaluating motor functions. The shortened version has 8 subscales (14 sections), assessing gross motor skills (4 subscales), fine motor skills (3 subscales), and a subscale evaluating both. Its test-retest reliability stands at 87%.
Measured: 12th week
Secondary outcomes (1)
Wisconsin Card Sorting Test (WCST)
The Wisconsin Card Sorting Test (WCST) is a psychological assessment tool that evaluates cognitive flexibility and problem-solving abilities. The WCST includes 4 stimulus cards and 128 response Cards. One red triangle, 2 green stars, 3 yellow crosses, or 4 blue circles are demonstrated in the stimulus cards. The 128 response cards contain pictures combining different shapes (triangles, stars, crosses, \& circles), colors (red, blue, yellow, \& green), and numbers (1, 2, 3, or 4). The cards are presented on a screen in the computer Version of the WCST. The participant has to choose an Answer card for matching with one of the 4 key cards Based on its potential characteristics with 4 cards. The reliability estimates for the accurate sorts, categories, and perseverative errors were within the favorable range (rel ≥ .90)
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start25 Feb 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, PhD-PT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308315
- Sponsor's protocol ID
- REC/RCR&AHS/23/0297
- Status last verified
- Oct 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic Balance Auditory Vision Training And Strength Training On Motor Function And Cognition In Children With Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT06308315
- Acronym / sponsor ID
- REC/RCR&AHS/23/0297
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Cognition, Motor function, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Mar 2024 (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.
Autism, a complex neurodevelopmental disorder that is marked by limited interests, and challenges in communication and social interactions and problem includes difficulties in understanding and responding to social cues, repetitive behaviors, intense focus on specific interests, and challenges with verbal and nonverbal communication. Rhythmic Balance Auditory Vision Training (RBAVT) a therapeutic approach which helps in improving coordination and balance in individuals with various neurological conditions. Strength training enhance physical health and muscle development. Thus, the purpose of this study is to compare the effects of rhythmic balance auditory vision training and strength training on motor function and cognition in children with autism spectrum disorder.
Detailed description
This randomized clinical trial will be conducted in Autism center Lahore. Sample of 76 patients will be recruited in this trial by using the convenience sampling technique. Participants will be randomly allocated in two groups using lottery method. Group A will receive Rhythmic balance visual auditory exercise. Group B will receive strength training exercises. Both groups will receive routine physical therapy as baseline treatment. All the participants will receive 3 sessions per week for 12 weeks.Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) will be used assessment tool to measure fine and gross motor skills and Wisconsin Card Sorting Test (WCST) will be assessment tool that evaluates cognitive flexibility and problem-solving abilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Rhythmic Training+ Routine Physical therapy) | Experimental | Other: Rhythmic balance visual auditory exercise + Routine physical therapyRhythmic balance auditory vision training will be given thrice a week for 8 weeks. it is a 45 minute training program that consist of: 1. 5 minute warm up activities (arm swings). 2. Bal-A-Vis-X training thrice a week for 20 minutes. 3. 5-minute cool down activities. Routine Physical therapy treatment for 15 minutes |
| Group B (Strength Training+ Routine Physical Therapy) | Experimental | Other: Strength Training + Routine Physical TherapyStrength training Program will be performed thrice a week for 8 weeks. session of 45 minute will be given to the patient. The expert managed sessions based on: 10-min warm-up activities, 25-min basic exercise 10- min cool-down activities. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age range between 6 and 12 years.
- Rating Scale (CARS) with scores ranging from 30 to 36.
- Confirmation of the diagnosis of autism by a psychiatrist based on Diagnostic and Statistical manual of Mental Disorders.
- Physical and cognitive ability
Key exclusion criteria (3 listed)
- Children with history of auditory, visual, or respiratory deficits, or fixed deformities of the extremities.
- Medical contraindications such as orthopedic or acute conditions that hinder participation in the exercise program.
- History of psychotropic medication within the last 4 weeks.
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 |
|---|---|---|
| Rhythmic balance visual auditory exercise + Routine physical therapy5 minute warm-up activities. Bal-A-Vis-X training includes: 1. Ball Rectangle; A and B hold one ball in each hand, simultaneously bounce right balls to patient left hand; while balls bounce, clap left balls on right hand; catch patient ball with left hand; continue pattern. Bounces must be simultaneous. (10 minutes) 2. Ball rectangle in which one hand has to toss a ball to a partner and the other hand catch an incoming bag from the partner and 2 ball drop/pass/catch, two-foot jumping forward, tandem walking on ground. (10 minutes) Routine Physical therapy treatment includes: Range of Motion exercises, Stretching, Strength, balance training for 15 minutes 5 minute cool-down activities. | Other | Group A (Rhythmic Training+ Routine Physical therapy) |
| Strength Training + Routine Physical TherapyThe expert managed sessions based on: 5 minute warm-up activities. 5 minute cool-down activities. Strength training includes 5 tasks for 20 minutes 1. core strengthening, 2. upper and lower limbs strength in both static positions as well as with dynamic movements 3. standing long jump, 4. knee push-ups, 5. sit-ups Routine Physical therapy treatment will be given for 15 minutes. It includes: Range of Motion exercises, Stretching, Strength, balance training. | Other | Group B (Strength Training+ Routine Physical Therapy) |
Primary outcome
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
Time frame: 12th week
The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) is a widely used assessment tool to measure fine and gross motor skills in individuals aged 4 to 20. It evaluates various aspects of motor proficiency, including running speed, balance, coordination, and fine motor control. The test helps identify motor skill strengths and weaknesses to aid in intervention and treatment planning. The BOTMP test is a valid assessment tool with 8 subscales (53 sections) for evaluating motor functions. The shortened version has 8 subscales (14 sections), assessing gross motor skills (4 subscales), fine motor skills (3 subscales), and a subscale evaluating both. Its test-retest reliability stands at 87%.
1 secondary outcome
Wisconsin Card Sorting Test (WCST)
Time frame: 12th week
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 15 Oct 2024.
- 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.
Muhammad Kashif, PhD-PT study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic balance visual auditory exercise + Routine physical therapy and Strength Training + Routine Physical Therapy 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 4 inclusion and 3 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 15 Oct 2024. 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 (BOT-2) (time frame: 12th week). 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 15 Oct 2024.