RecruitingNot ApplicableNCT07519369

Monitoring Daily Mobility in Children With Autism

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


Sponsor

IRCCS San Raffaele Roma

Enrollment

80 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEplacement 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.


Locations(1)

IRCCS San Raffaele

Roma, RM, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07519369


Related Trials