Ireland
--:--IST
Recruiting Not applicable

Monitoring Daily Mobility in Children With Autism

NCT07519369 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2026-02-18
Last updated
2026-04-09

Condition(s) studied

Autism Spectrum Disorder (ASD

Investigational drug(s) / intervention(s)

placement of a wearable wrist sensor

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.

Study 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

Sex
ALL
Min age
2 Years
Max age
18 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Roma RM Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07519369 on ClinicalTrials.gov ↗ ← All trials in Italy