RecruitingNANCT07519369

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

Sponsor: IRCCS San Raffaele Roma

Trial Details

ConditionAutism Spectrum Disorder (ASD
Interventionplacement of a wearable wrist sensor
PhaseNA
StatusRecruiting
Participants80
Est. Completion1 June 2026
Last Updated9 Apr 2026

Primary Outcome

Feasibility and adherence to continuous use of a wearable sensor in children with autism spectrum disorder (ASD)

Eligibility Criteria

Inclusion Criteria

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

Trial Sites

Countries

Italy
View Registry Entry

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