Monitoring Daily Mobility in Children With Autism (SIMBA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder (ASD
• Intervention / Treatment: Device: placement of a wearable wrist sensor

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00163
      • Recruiting
      • IRCCS San Raffaele
      • Contact: Federico Vigevano, MD; Phone Number: +39 06660581; Email: federico.vigevano@sanraffaele.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASD patient cohort	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.; Other Names: polysomnography; gait analysis
Active Comparator: cohort of healthy controls	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.; Other Names: polysomnography; gait analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD)	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Pattern	To characterize gait patterns in children and adolescents with autism spectrum disorder	during the enrollment period with wearable sensor
ASD subgroups	To identify potential phenotypic subgroups within the ASD population (e.g., different gait patterns according to age or phenotypic severity)	during the enrollment period using the wearable sensor
Daily activity and sleep quality	To investigate the relationship between sleep quality, daily motor activity (daytime activity, fragmentation/variability), and sensory processing.	during the enrollment period using a wearable sensor

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: sleep; ASD; movement disorders; Autism Spectrum Disorder
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Movement Disorders; Diagnostic Techniques and Procedures; Diagnosis; Population Characteristics; Physical Examination; Health; Monitoring, Physiologic; Physical Fitness; Gait; Physical Functional Performance; Polysomnography; Gait Analysis
• Other Study ID Numbers: 425/SR/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No