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

Trunk Control Mediates the Association Between Autism Severity and Functional Exercise Capacity in Children With Autism Spectrum Disorder

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder (ASD)

Detailed Description

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by decreased cardiorespiratory fitness and motor impairments that limit participation in daily activities. Children with ASD commonly show reduced postural stability and trunk motor control (the ability to maintain and adjust the position of the upper body during movement). These impairments are increasingly recognized as significant contributors to functional limitations in individuals with ASD, yet the precise mechanism linking autism severity to reduced functional exercise capacity has not been formally tested.

This cross-sectional study tests a mediation model: whether trunk motor control explains the relationship between ASD severity and functional exercise capacity. ASD severity is classified using DSM-5 levels (Level 1, 2, and 3) from existing clinical records. Trunk motor control is assessed using the Trunk Impairment Scale (TIS), a validated tool measuring static balance, dynamic balance, and trunk coordination. Functional exercise capacity is measured using the Six-Minute Walk Test (6MWT), conducted per American Thoracic Society guidelines.

Statistical analysis uses bootstrap mediation (PROCESS Model 4, 5,000 resamples), controlling for age, sex, and BMI. This is the first study to examine this mediation pathway in a paediatric hospital setting in Pakistan, where no motor profile has been described in the literature for children with ASD.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54782
      • Dr. Saqib Rabbani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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
• Able to attempt the Six-Minute Walk Test (6MWT) with or without verbal prompting
• Written informed consent from parent or legal guardian; verbal assent from child where developmentally appropriate (aged 7 years and above)

Exclusion Criteria:

• 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
• Caregiver refusal of consent or participant non-cooperation with either assessment tool at the time of the visit

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
ASD Level 1 - Requiring Support; Children aged 4-12 years with a confirmed DSM-5 diagnosis of ASD at severity Level 1 (requiring support). Participants undergo a single assessment session comprising the Trunk Impairment Scale (TIS) to measure trunk motor control and the Six-Minute Walk Test (6MWT) to measure functional exercise capacity. No intervention is administered.
ASD Level 2 - Requiring Substantial Support; Children aged 4-12 years with a confirmed DSM-5 diagnosis of ASD at severity Level 2 (requiring substantial support). Participants undergo a single assessment session comprising the Trunk Impairment Scale (TIS) to measure trunk motor control and the Six-Minute Walk Test (6MWT) to measure functional exercise capacity. No intervention is administered.
ASD Level 3 - Requiring Very Substantial Support; Children aged 4-12 years with a confirmed DSM-5 diagnosis of ASD at severity Level 3 (requiring very substantial support). Participants undergo a single assessment session comprising the Trunk Impairment Scale (TIS) to measure trunk motor control and the Six-Minute Walk Test (6MWT) to measure functional exercise capacity. No intervention is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Day

Collaborators and Investigators

• Sponsor: Dr. Mehak Naeem

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: UHS/IRB-26/1974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data will not be shared, as the study involves a vulnerable paediatric population. Participant confidentiality and privacy are protected under the study's ethical approval conditions and applicable national research regulations of Pakistan.

Drug and device information, study documents

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