- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 54782
- Dr. Saqib Rabbani
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional Exercise Capacity
기간: 1 Day
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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.
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1 Day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Trunk Motor Control
기간: 1 Day
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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.
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1 Day
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UHS/IRB-26/1974
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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