Effects of Rhythmic Balance Auditory Vision Training And Strength Training With Autism Spectrum Disorder.

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Rhythmic balance visual auditory exercise + Routine physical therapy; Other: Strength Training + Routine Physical Therapy

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54660
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range between 6 and 12 years.
2. Rating Scale (CARS) with scores ranging from 30 to 36.
3. Confirmation of the diagnosis of autism by a psychiatrist based on Diagnostic and Statistical manual of Mental Disorders.
4. Physical and cognitive ability

Exclusion Criteria:

1. Children with history of auditory, visual, or respiratory deficits, or fixed deformities of the extremities.
2. Medical contraindications such as orthopedic or acute conditions that hinder participation in the exercise program.
3. History of psychotropic medication within the last 4 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Rhythmic Training+ Routine Physical therapy); Rhythmic balance auditory vision training will be given thrice a week for 8 weeks. it is a 45 minute training program that consist of: 5 minute warm up activities (arm swings).; Bal-A-Vis-X training thrice a week for 20 minutes.; 5-minute cool down activities. Routine Physical therapy treatment for 15 minutes	Other: Rhythmic balance visual auditory exercise + Routine physical therapy; 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.
Experimental: Group B (Strength Training+ Routine Physical Therapy); 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.	Other: Strength Training + Routine Physical Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12th week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Muhammad Kashif, PhD-PT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Autism; Cognition; Motor function; Strength training
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: REC/RCR&AHS/23/0297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No