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Monitoring Daily Mobility in Children With Autism

RecruitingNAAges 2 Years - 18 YearsAllIRCCS San Raffaele Roma
NCT07519369 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • placement of a wearable wrist sensor
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Where

1 site
IRCCS San Raffaele
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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