Monitoring Daily Mobility in Children With Autism
ConditionAutism Spectrum Disorder (ASD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorIRCCS San Raffaele Roma
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
placement of a wearable wrist sensor
DeviceThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ASD patient cohortExperimental treatment 1 intervention
Group B: cohort of healthy controlsActive comparator 1 intervention
Trial outcomes
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.
Time frame
7 daysSecondary outcomes
1
Gait Pattern
To characterize gait patterns in children and adolescents with autism spectrum disorder
Time frame
during the enrollment period with wearable sensor2
ASD subgroups
To identify potential phenotypic subgroups within the ASD population (e.g., different gait patterns according to age or phenotypic severity)
Time frame
during the enrollment period using the wearable sensor3
Daily activity and sleep quality
To investigate the relationship between sleep quality, daily motor activity (daytime activity, fragmentation/variability), and sensory processing.
Time frame
during the enrollment period using a wearable sensorSponsors and contacts
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Source ClinicalTrials.gov