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NCT07519369Recruiting

Monitoring Daily Mobility in Children With Autism

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
2 Apr 2026
Start date
18 Feb 2026
Primary completion date
Dec 2026
Lead sponsor
IRCCS San Raffaele Roma
Diseases
Autism
NCT number
NCT07519369

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 18 Feb 2026 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent orthopedic surgery (\<6 months)

Other illness

  • Skin contraindications to the wristband/fixation systems (known material allergies, active wrist dermatitis, or skin lesions preventing prolonged use)
  • Severe behavioral disorder making device use impracticable despite acclimatization strategies

Other

  • Severe motor impairments
  • Use of orthoses or assistive devices during walking

Who the study is looking for

  • 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

Age in the registry: 2 years to 18 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS San Raffaele
Coordinator of this site? Confirm its status
RomaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.