- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240740
WittyChildren - Advanced Technology for Response Time Evaluation in Children Affected by Developmental Disorders
November 18, 2025 updated by: IRCCS Eugenio Medea
WittyChildren: a Quantitative Evaluation of Motor-cognitive Coordination
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
LC
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Bosisio Parini, LC, Italy, 23842
- IRCCS E. Medea
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients affected by unilateral cerebral palsy
Description
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:
- Severe cognitive impairment.
- Severe visual impairment
- Uncontrolled epilepsy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reaction time - before rehabilitation
Time Frame: Baseline, before starting rehabilitation treatment
|
Reaction time as measured through optoelectronic data.
|
Baseline, before starting rehabilitation treatment
|
|
Reaction time - after rehabilitation
Time Frame: After one month
|
Reaction time as measured through optoelectronic data.
|
After one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2023
Primary Completion (Actual)
January 31, 2025
Study Completion (Actual)
January 31, 2025
Study Registration Dates
First Submitted
April 30, 2025
First Submitted That Met QC Criteria
November 18, 2025
First Posted (Actual)
November 21, 2025
Study Record Updates
Last Update Posted (Actual)
November 21, 2025
Last Update Submitted That Met QC Criteria
November 18, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 984
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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