Autism Spectrum Disorder (ASD)NCT07634107
How Trunk Control Links Autism Severity to Functional Exercise Capacity in Children With ASD
An observational study of Autism Spectrum Disorder (ASD), run by Dr. Mehak Naeem at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2026to Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- Does trunk control explain why children with more severe ASD have lower functional exercise capacity?
- Do trunk control and functional exercise capacity differ across ASD severity levels (Level 1, 2, and 3)?
Read more
Participants will complete two assessments in a single 30-40 minute session during their routine clinic visit:
- A trunk control test, where a trained physiotherapist observes seated balance and movement.
- 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder (ASD)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dr. Mehak Naeem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Mehak Naeem, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634107
- Sponsor's protocol ID
- UHS/IRB-26/1974
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Control Mediates the Association Between Autism Severity and Functional Exercise Capacity in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07634107
- Acronym / sponsor ID
- UHS/IRB-26/1974
- Conditions
- Autism Spectrum Disorder (ASD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Mehak NaeemUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does trunk control explain why children with more severe ASD have lower functional exercise capacity?
- 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:
- A trunk control test, where a trained physiotherapist observes seated balance and movement.
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Exercise Capacity
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.
1 secondary outcome
Trunk Motor Control
Time frame: 1 Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder (ASD), run by Dr. Mehak Naeem at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Exercise Capacity (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.