Monitoring Daily Mobility in Children With Autism (SIMBA)

April 2, 2026 updated by: IRCCS San Raffaele Roma

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD)
Time Frame: 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.
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait Pattern
Time Frame: during the enrollment period with wearable sensor
To characterize gait patterns in children and adolescents with autism spectrum disorder
during the enrollment period with wearable sensor
ASD subgroups
Time Frame: during the enrollment period using the wearable sensor
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
Time Frame: during the enrollment period using a wearable sensor
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Raffaele Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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