Monitoring Daily Mobility in Children With Autism

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device placement of a wearable wrist sensor
  The project integrates three complementary modules on the same participant: (A) monitoring with wearable sensors (primary objective), (B) laboratory-based gait analysis, and (C) sleep assessment using home video-EEG polysomnography (PSG). The reference wearable instrumentation follows the technical protocols established by the Politecnico di Milano, which already include the use of the AX6 device and F-Scan GO insoles among the wearable devices available within the research program.

Primary outcome measures

• Feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD) [Time frame: 7 days]

Secondary outcome measures (3)

• Gait Pattern [Time frame: during the enrollment period with wearable sensor]
• ASD subgroups [Time frame: during the enrollment period using the wearable sensor]
• Daily activity and sleep quality [Time frame: during the enrollment period using a wearable sensor]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Italy · 1 center

• IRCCS San Raffaele — Roma

Identifiers

NCT: NCT07519369 · 425/SR/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗