NCT05013528

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 11, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

August 16, 2021

Last Update Submit

April 15, 2022

Conditions

Autism Spectrum Disorder

Keywords

Aerobic TrainingAutism Spectrum DisorderBal-A-Vis-XBalance Auditory Vision Training

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 weeks

Study Arms (2)

Bal-A-Vis-X training Group

EXPERIMENTAL

Bal-A-Vis-X training Group

Other: Bal-A-Vis-X trainingOther: Aerobic Training Group

Aerobic Training Group

ACTIVE COMPARATOR

Aerobic Training Group

Other: Bal-A-Vis-X trainingOther: Aerobic Training Group

Interventions

Bal-A-Vis-X trainingOTHER

Bal-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. .

Also known as: Group A
Aerobic Training GroupBal-A-Vis-X training Group
Aerobic Training GroupOTHER

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

Also known as: Group B
Aerobic Training GroupBal-A-Vis-X training Group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Give Consent to take part
  • Children diagnosed with ASD by psychologist

You may not qualify if:

  • Having co-morbidities like schizophrenia and developmental delay
  • Showing aggressive behavior
  • Having disease of cardiovascular or respiratory system
  • Children with auditory and visual impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Dream Center

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Aruba Saeed, MS-NMPT*

    Riphah international university.pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Neither subjects nor the investigator who is assessing the patient are aware of the treatment assignment until the end of the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 19, 2021

Study Start

November 11, 2021

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)