Actively Recruiting

Phase Not Applicable
Age: 2Years - 18Years
All Genders
Healthy Volunteers
NCT07519369

Monitoring Daily Mobility in Children With Autism

Led by IRCCS San Raffaele Roma · Updated on 2026-04-09

80

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Monitoring Daily Mobility in Children With Autism

Who Can Participate

Age: 2Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Skin contraindications to the wristband/fixation systems such as known material allergies, active wrist dermatitis, or skin lesions preventing prolonged use
  • Severe motor impairments
  • Recent orthopedic surgery within the last 6 months
  • Use of orthoses or assistive devices during walking
  • Severe behavioral disorder making device use impracticable despite acclimatization strategies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

IRCCS San Raffaele

Roma, RM, Italy, 00163

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here