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

6 juni 2026 bijgewerkt door: Dr. Mehak Naeem

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional Exercise Capacity
Tijdsspanne: 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 Day

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Trunk Motor Control
Tijdsspanne: 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.
1 Day

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 juli 2026

Studie voltooiing (Geschat)

1 juli 2026

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

6 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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