Dr. Saqib Rabbani
Lahore, Punjab Province, 54782, Pakistan
NCT Number: NCT07634107
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.
Trial opening soon.
Get Notified4 year–12 year
All sexes
Observational
Lahore, Punjab Province, 54782, Pakistan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 Day
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
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.
Dr. Mehak Naeem
Other
Trunk Control Mediates the Association Between Autism Severity and Functional Exercise Capacity in Children With Autism Spectrum Disorder
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