Unilateral Cerebral palsy (UCP) is the most common neurological chronic disease in childhood with a significant burden on children, their families and health care system.
AInCP aims to develop evidence-based clinical Decision Support Tools (DST) for personalized functional diagnosis, Upper Limb (UpL) assessment and home-based intervention for children with UCP, by developing, testing and validating trustworthy Artificial Intelligence (AI) and cost-effective strategies. The AInCP approach will: i) establish a clinical diagnosis and accurate prognosis for treatment response of individual UCP profiles, by employing a multimodal approach including clinical phenotyping, advanced brain imaging and real-life monitoring of UpL function, and ii) provide personalized home-based treatment, from advanced ICT and AI technologies.
The AInCP will build upon personalized diagnostic and rehabilitative DST (dDST and rDST) to be developed and validated through large observational and rehabilitation studies, including at least 200 and 150 children with UCP, respectively. Using data driven and AI approach, dDST and rDST will be combined for developing a theranostic DST (tDST) that will allow the re-designing of an economical, ethical, sustainable decision-making process for delivering a personalized and validated approach, focused on the care, monitoring and rehabilitation of UpL in children with UCP. AInCP is a significant example of a transdisciplinary approach, where all project collaborators (clinicians, data scientists, physicists, engineers, economists, ethicists, SMEs, children and parent associations) will work closely together in building the AInCP approach. This approach will, therefore, hinge on transdisciplinary contributions, multi- dimensional data, sets of innovative devices and fair AI-based algorithms, clinically effective and able to reduce users? and market barriers of acceptability, reimbursability and adoption of the proposed solution.
Children with confirmed diagnosis of UCP mainly spastic form
Ages from 5 to 15 years old
Manual ability levels from I to III in the Manual Ability Classification System (MACS)
Severe Upper Limb (UpL) impairment (MACS ≥ level IV: inability to grasp)
Botulinum toxin-A injections in UpL within 6 months prior to study entry
UpL surgery within 12 months prior to study entry
Severe comobordities and/or severe cognitive disability
Children aged from 5 to 15 years old with a diagnosis of Unilateral Cerebral Palsy, mainly spastic form, with an impairment at the Upper Limb from mild to severe. Children aged from 5 to 15 years old with a typical development.
Case-control
Prospective
Artificial Intelligence for combining multi-domain data acquisition
Other interventionArtificial Intelligence and machine learning techniques to combine data coming from multidomains data collection (such as clinical multiaxial assessments and questionnaires, Neuroimaging, Upper limb movement analysis during clinical assessment and daily life )
score of modified Ashworth Scale (MAS)
Test for estimating the muscle tone (i.e., the resistance felt by the examiner when performing a passive stretch of a muscle), which will be apply to the muscles of the upper limb. The child will lie or sit in a comfortable position, and the examiner will stretch the upper limb in different ways, in order to assess the tension each muscle imposes when stretched.
score of grip strenght by means of Jamar dynamometer Grip strength will be assessed with the Jamar dynamometer
Jamar is a regular hydraulic dynamometer and is the most widely reported device used to measure grip strength. The child will perform three trials for each hand, where he/she will be asked to squeeze the handle of the dynamometer as strongly as possible. The values shown on the monitor will be noted for each trial.
score of mirror movements
Mirror movements of the hands refer to the involuntary movements of the less-affected hand, which mimic voluntary movements of the more affected hand. These movements will be assessed with the Woods and Teuber scale (Woods \& Teuber, 1978), which is a five-point scale describing the degree of mirror movements. The child will be asked to perform three tasks shown in figure 2: (1) fist opening and clenching, (2) finger opposition (thumb sequentially touches other four digits), and (3) finger tapping (fingers are sequentially lifted from the table surface) and after observation of the examiner, the mirror movements will be classified.
score of Stereognosis (tactile object identification)
The ability to identify objects only by touching them will be assessed with a simple test that includes 12 daily objects (e.g., a spoon, a toothbrush, a coin). The child will be asked to touch some items one-by-one, with his/her vision occluded and will have to report the name of the item touched in every trial.
Click on the lead sponsor to view all of their trials.
IRCCS Fondazione Stella Maris
Lead sponsor
University of Pisa
Collaborator
University of Castilla-La Mancha
Collaborator
Fight The Stroke
Collaborator
SCUOLA SUPERIORE DI STUDI UNIVERSITARI E DI PERFEZIONAMENTO S ANNA
Collaborator
Noldus Information Technology Bv
Collaborator
Khymeia
Collaborator
Tyromotion GMBH
Collaborator
The University of Queensland
Collaborator
University of Salento
Collaborator
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