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

NCT07634107 | Not Yet Recruiting DMC

• 1 other identifier: UHS/IRB-26/1974
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does trunk control explain why children with more severe ASD have lower functional exercise capacity?
2. 2.Do trunk control and functional exercise capacity differ across ASD severity levels (Level 1, 2, and 3)?
3. 3.A trunk control test, where a trained physiotherapist observes seated balance and movement.
4. 4.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.

Conditions

Autism Spectrum Disorder (ASD)

Outcome Measures

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.

  1 Day

Secondary Outcomes (1)

• Trunk Motor Control

  1 Day

Study Arms (3)

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.

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Mehak Naeem: lead

Study Sites (1)

Dr. Saqib Rabbani

Lahore, Punjab Province, 54782, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

PA (1)