跳至主要内容
临床试验/NCT07519369
NCT07519369招募中不适用

Innovative Solution With Wearable Sensors for Monitoring Daily Mobility in Children With Autism

IRCCS San Raffaele Roma1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD)

研究概览

简要总结

Children with autism spectrum disorder (ASD) often show motor abnormalities and sleep disturbances that affect behavior, learning, and family quality of life. Emerging technologies such as wearable devices and markerless systems provide accessible tools for gait and sleep assessment, with actigraphy recommended for long-term monitoring in natural settings. Evidence also suggests links between sleep problems and sensory processing differences. This project, aims to integrate these approaches in a clinical-translational framework.

详细描述

This study aims to better understand how children with autism spectrum disorder (ASD) move and sleep in their everyday lives, and how these aspects may be connected to their overall development and well-being. Children with ASD often experience differences in motor skills, such as walking and coordination, as well as sleep difficulties, which can affect their behavior, learning, and family life. To address these challenges, the study uses innovative and non-invasive technologies, including wearable devices (such as wrist sensors and smart insoles) and video-based systems that can analyze movement without the need for markers or complex laboratory setups. These tools allow researchers to monitor children in more natural environments, such as at home, over several days. The project combines three main components: continuous monitoring of daily activity through wearable sensors, detailed gait analysis in a clinical setting, and sleep evaluation using both wearable devices and home-based sleep recordings. By integrating these data, the study seeks to identify patterns in movement and sleep, and to explore how they relate to sensory processing differences often seen in children with ASD. The ultimate goal is to develop more personalized and accessible approaches to assessment and care, helping clinicians and families better understand each child's needs and support their development through targeted interventions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria
  • Age between 2 and 18 years
  • Ability to walk independently
  • Willingness to wear a wearable device (wrist sensor) continuously for 7 days and pedobarographic insoles for reproducible gait monitoring
  • Willingness to undergo one night of home polysomnography with video-EEG/polygraphy during the wearable monitoring period
  • Informed consent signed by both parents/legal guardian; assent from the minor when applicable

排除标准

  • Skin contraindications to the wristband/fixation systems (known material allergies, active wrist dermatitis, or skin lesions preventing prolonged use)
  • Severe motor impairments
  • Recent orthopedic surgery (<6 months)
  • Use of orthoses or assistive devices during walking
  • Severe behavioral disorder making device use impracticable despite acclimatization strategies

研究组 & 干预措施

ASD patient cohort

Experimental

干预措施: placement of a wearable wrist sensor (Device)

cohort of healthy controls

Active Comparator

干预措施: placement of a wearable wrist sensor (Device)

结局指标

主要结局

Feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD)

时间窗: 7 days

This objective aims to assess the feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD), evaluating tolerability, compliance, and data quality in real-life conditions over a 7-day monitoring period. Feasibility is primarily defined as the proportion of participants completing the protocol with valid data, while adherence is assessed through wear time, data completeness, and caregiver-reported acceptability.

次要结局

  • Gait Pattern(during the enrollment period with wearable sensor)
  • ASD subgroups(during the enrollment period using the wearable sensor)
  • Daily activity and sleep quality(during the enrollment period using a wearable sensor)

研究者

发起方
IRCCS San Raffaele Roma
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验