- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07634107
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:
- 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistán, 54782
- Dr. Saqib Rabbani
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Exercise Capacity
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Trunk Motor Control
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UHS/IRB-26/1974
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .