Autism Spectrum Disorder (ASDSIMBANCT07519369
Monitoring Daily Mobility in Children With Autism
A study testing placement of a wearable wrist sensor in people with Autism Spectrum Disorder (ASD, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD
- What is being tested?
- placement of a wearable wrist sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 18 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Roma, RM, 00163
Federico Vigevano, MD, +39 06660581, federico.vigevano@sanraffaele.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder (ASD
- Being tested
- placement of a wearable wrist sensor
- Keywords
- Autism Spectrum Disorder, ASD, sleep, movement disorders
- Medical subject headings
- Autism Spectrum Disorder, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of a wearable wrist sensorDevice
Also called polysomnography, gait analysis
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 group | Role | What they receive |
|---|---|---|
| ASD patient cohort | Experimental | Not described Receives: Device: placement of a wearable wrist sensor |
| cohort of healthy controls | Active comparator | Not described Receives: Device: placement of a wearable wrist sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (3)
Gait Pattern
To characterize gait patterns in children and adolescents with autism spectrum disorder
Measured: 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)
Measured: 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.
Measured: during the enrollment period using a wearable sensor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start18 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519369
- Sponsor's protocol ID
- 425/SR/25
- Acronym
- SIMBA
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Solution With Wearable Sensors for Monitoring Daily Mobility in Children With Autism
- ClinicalTrials.gov ID
- NCT07519369
- Acronym / sponsor ID
- SIMBA / 425/SR/25
- Conditions
- Autism Spectrum Disorder (ASD
- Keywords
- Autism Spectrum Disorder, ASD, sleep, movement disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ASD patient cohort | Experimental | Device: placement of a wearable wrist sensor |
| cohort of healthy controls | Active comparator | Device: placement of a wearable wrist sensor |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placement of a wearable wrist sensorAlso: polysomnography, gait analysisThe 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. | Device | ASD patient cohort, cohort of healthy controls |
Primary outcome
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.
3 secondary outcomes
Gait Pattern
Time frame: during the enrollment period with wearable sensor
ASD subgroups
Time frame: during the enrollment period using the wearable sensor
Daily activity and sleep quality
Time frame: during the enrollment period using a wearable sensor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing placement of a wearable wrist sensor in people with Autism Spectrum Disorder (ASD, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.