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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06308315
Other study ID # REC/RCR&AHS/23/0297
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 25, 2024
Est. completion date May 15, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact Muhammad Kashif, PhD-PT
Phone 03333125303
Email Kashif.shaffi@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date May 15, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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