Monitoring Daily Mobility in Children With Autism

NCT07519369 | Recruiting

• 1 other identifier: 425/SR/25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder (ASD

Keywords

Autism Spectrum Disorder; ASD; sleep; movement disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

ASD patient cohort

EXPERIMENTAL

Device: placement of a wearable wrist sensor

cohort of healthy controls

ACTIVE COMPARATOR

Device: placement of a wearable wrist sensor

Interventions

placement of a wearable wrist sensor DEVICE

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.

Also known as: polysomnography, gait analysis

ASD patient cohort; cohort of healthy controls

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele

Roma, RM, 00163, Italy

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Movement Disorders

Interventions

Polysomnography; Gait Analysis

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Gait; Physical Examination; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study examines motor activity and sleep patterns in children and adolescents with autism spectrum disorder (ASD) using a multimodal, non-invasive approach. It includes: (A) continuous monitoring with wearable sensors, (B) laboratory gait analysis, and (C) home video-EEG polysomnography (PSG), with a control group. Participants aged 2-18 years complete a standardized protocol. At baseline, clinical data are collected, wearable devices (AX6 wrist sensor and F-Scan GO insoles) are applied, and gait is assessed using both marker-based and AI markerless systems. Sensory processing is evaluated with the Sensory Profile 2. Over a 7-day home phase, devices record daily activity and sleep-wake patterns. Sleep is also assessed with 1-2 nights of home PSG, allowing comparison with wearable data. At follow-up, devices are returned, data are checked, and caregiver feedback is collected. The study evaluates feasibility and explores links between movement, sleep, and sensory processing.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: February 18, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-03

Locations

IT (1)