How Trunk Control Links Autism Severity to Functional Exercise Capacity in Children With ASD

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-12
SponsorDr. Mehak Naeem

About this trial

The goal of this observational study is to learn if trunk control (the ability to balance and stabilize the upper body while sitting or moving) links autism severity to functional exercise capacity in children aged 4-12 years with Autism Spectrum Disorder (ASD). The main questions it aims to answer are:

1. Does trunk control explain why children with more severe ASD have lower functional exercise capacity? 2. Do trunk control and functional exercise capacity differ across ASD severity levels (Level 1, 2, and 3)?

Participants will complete two assessments in a single 30-40 minute session during their routine clinic visit:

1. A trunk control test, where a trained physiotherapist observes seated balance and movement. 2. A 6-Minute Walk Test (6MWT), where the child moves along a flat hospital corridor for 6 minutes and the total distance covered is recorded as a measure of functional exercise capacity.

No treatment or intervention is involved. All assessments are safe, non-invasive, and conducted at a tertiary care children's hospital in Pakistan.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 4-12 years (inclusive) at the time of assessment

Confirmed diagnosis of ASD according to DSM-5 criteria, documented in the hospital record by a licensed clinical psychologist or developmental paediatrician

Classified at DSM-5 severity Level 1, 2, or 3 in the existing clinical file

Currently attending physiotherapy or developmental rehabilitation outpatient services at the hospital

Disqualifiers

Co-existing neurological condition independently affecting gait (e.g., cerebral palsy, uncontrolled epilepsy)

Orthopaedic condition precluding walking or safe execution of the Trunk Impairment Scale

Acute illness, fever, or significant behavioural crisis at the time of the scheduled assessment session

Current enrolment in a structured physiotherapy or physical activity intervention programme

Trial population

Participants will be recruited consecutively from the developmental and rehabilitation paediatric physiotherapy outpatient department of a tertiary care children's hospital in Pakistan.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 3 trial groups
Group A: ASD Level 1 - Requiring Support
Group B: ASD Level 2 - Requiring Substantial Support
Group C: ASD Level 3 - Requiring Very Substantial Support

Trial outcomes

Primary outcomes

1

Functional Exercise Capacity

Total distance covered in metres during the Six-Minute Walk Test (6MWT), administered in accordance with American Thoracic Society (ATS) guidelines along a 30-metre flat hospital corridor. The 6MWT is a validated, low-cost index of functional exercise capacity applicable to paediatric clinical settings. There is no fixed minimum or maximum value. A greater distance indicates better functional exercise capacity. Whereas a shorter distance indicates poorer functional exercise capacity. 6MWT distance will be analysed as a continuous variable and compared across DSM-5 severity levels.

Time frame
1 Day

Secondary outcomes

1

Trunk Motor Control

Total score on the Trunk Impairment Scale (TIS), a validated clinician-administered tool scored from 0 to 23 across three subscales: static sitting balance (0-7), dynamic sitting balance (0-10), and trunk coordination (0-6). Higher scores indicate better trunk motor control.

Time frame
1 Day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Mehak Naeem

Lead sponsor

University of Health Sciences Lahore

Sponsor institution

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