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CompletedNCT07240740Updated Nov 21, 2025

WittyChildren - Advanced Technology for Response Time Evaluation in Children Affected by Developmental Disorders

An observational study in Cerebral Palsy, sponsored by IRCCS Eugenio Medea. Completed at 1 site in Italy. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by IRCCS Eugenio Medea · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
7 Years to 18 Years
Sex
All
01

Study summary

The WittyChildren project aims to evaluate the response to visual stimuli in terms of reaction times and movement execution using advanced instruments. The evaluation is aimed at children with motor and cognitive deficits associated with various pathologies such as Down Syndrome, Infantile Cerebral Palsy, Autism. The evaluation protocol involves the execution of specific memory tasks: the child is asked to turn off light targets equipped with proximity sensors by approaching their hand. These visual signals, consisting of colored lights and symbols, are emitted according to pre-established patterns by a dedicated LED system (WittySEM - Microgate) capable of precisely measuring reaction times. During the execution of the task, quantitative and multifactorial analysis of movement and posture is also performed using an optoelectronic system (Smart DX - BTS Bioengineering) in order to obtain a complete analysis obtained from the combination of information regarding the child's motor and cognitive abilities. The analysis is repeated pre- and post-specific rehabilitation treatment, such as ARMEO, CIMT and occupational therapy, with the aim of evaluating the effects with objective and quantitative measurements through cutting-edge instruments, thus overcoming the intrinsic limits of commonly used scales and clinical tests. The project will be implemented in collaboration with the Politecnico di Milano - Lecco Territorial Campus and the IRCCS Eugenio Medea - Associazione la nostra famiglia. The first will provide the study with the necessary equipment at the "Human Performance Laboratory - E4Sport" of the Lecco Territorial Campus and the biomechanical engineering skills. The second, thanks to its consolidated experience in the treatment, rehabilitation and research of childhood pathologies, will provide the necessary support from a medical/rehabilitative point of view.

02

Conditions studied

  • Cerebral Palsy

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03

In context

Cerebral Palsy

1,852 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.

This study's enrollment of 20 is below the median of 63 across 454 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

IRCCS Eugenio Medea is the lead sponsor of 104 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients affected by unilateral cerebral palsy

Inclusion criteria

  • Pediatric age (\< 18 years);
  • Diagnosis of hemiplegia or hemiplegic CP;
  • Ability to understand and follow given motor instructions;
  • Ability to move such that the use of crutches or wheelchairs is not required.

Exclusion criteria

Exclusion Criteria:

  • Severe cognitive impairment.
  • Severe visual impairment
  • Uncontrolled epilepsy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Interventions

  • DeviceThe WittySEM system, in addition to simultaneously allowing the evaluation of the movement associated with the execution of the task, also provides for an active and "play-like" involvement of the sub

    The possibility of using tools for objective and quantitative evaluations can overcome these limitations. Added to this is the need to evaluate the beneficial effects of rehabilitation so as to understand its effectiveness and impact on quality of life. However, it is difficult to resort to tests that use dedicated devices such as the WittySEM system which, in addition to simultaneously allowing the evaluation of the movement associated with the execution of the task, also provides for an active and "play-like" involvement of the subject which should not be underestimated in the case of children.

06

What researchers measure

Primary outcomes

  1. Reaction time - before rehabilitation

    Reaction time as measured through optoelectronic data.

    Time frame: Baseline, before starting rehabilitation treatment

  2. Reaction time - after rehabilitation

    Reaction time as measured through optoelectronic data.

    Time frame: After one month

07

Study locations

1 site
  • IRCCS E. Medea
    Bosisio Parini, LC 23842, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07240740
Lead sponsor
IRCCS Eugenio Medea
Collaborators
Politecnico di Milano
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Jan 23, 2023
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Nov 21, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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