Cerebral PalsyNCT07240740
WittyChildren - Advanced Technology for Response Time Evaluation in Children Affected by Developmental Disorders
An observational study of Cerebral Palsy, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- The 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
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jan 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients affected by unilateral cerebral palsy
Who may be able to join
- 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.
Who cannot join
- Severe cognitive impairment.
- Severe visual impairment
- Uncontrolled epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cerebral Palsy
- Being tested
- The 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
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 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 subDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time - before rehabilitation
Reaction time as measured through optoelectronic data.
Measured: Baseline, before starting rehabilitation treatment
Reaction time - after rehabilitation
Reaction time as measured through optoelectronic data.
Measured: After one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start23 Jan 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240740
- Sponsor's protocol ID
- 984
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WittyChildren: a Quantitative Evaluation of Motor-cognitive Coordination
- ClinicalTrials.gov ID
- NCT07240740
- Acronym / sponsor ID
- 984
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Politecnico di Milano
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients affected by unilateral cerebral palsy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Severe cognitive impairment.
- Severe visual impairment
- Uncontrolled epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 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 subThe 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. | Device | – |
Primary outcome
Reaction time - before rehabilitation
Time frame: Baseline, before starting rehabilitation treatment
Reaction time as measured through optoelectronic data.
Reaction time - after rehabilitation
Time frame: After one month
Reaction time as measured through optoelectronic data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time - before rehabilitation (time frame: Baseline, before starting rehabilitation treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.