NCT06308315

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

March 4, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

AutismCognitionMotor functionStrength training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Wisconsin Card Sorting Test (WCST)

    12th week

Study Arms (2)

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

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.

Other: Strength Training + Routine Physical Therapy

Interventions

5 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.

Group A (Rhythmic 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 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.

Group B (Strength Training+ Routine Physical Therapy)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Kashif, PhD-PT

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient would be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 13, 2024

Study Start

February 25, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations