Artificial Intelligence for developing a personalised functional profile and supporting upper-limb rehabilitation decision-making in children with unilateral Cerebral Palsy (AInCP): protocol for an observational study

@article{sgandurra2026artificial,
  title = {{Artificial Intelligence for developing a personalised functional profile and supporting upper-limb rehabilitation decision-making in children with unilateral Cerebral Palsy (AInCP): protocol for an observational study}},
  author = {Giuseppina Sgandurra and Alexandra Kalkantzi and Elena Beani and Giovanni Cioni and Rocio Palomo Carrión and Hilde Feys and Nana Nino Tatishvili and Matteo Cianchetti and Fiorella Battaglia and Giuseppe Turchetti and Wil Van Dommelen and Marco Pirini and Francesca Fedeli and Clara Bombonato and Maria Chiara Di Lieto and Benedetta Del Lucchese and Veronica Barzacchi and Valentina Menici and Annalisa Cotardo and Marta Rizzo and Eleonora Bieber and Pietro Ilio Gatti and Federica Camuncoli and Michela Tosetti and Paolo Bosco and Laura Biagi and Luca Peretti and Francy Cruz-Sanabria and Cristina Lirio-Romero and María Coello-Villalón and Purificación López-Muñoz and Julián Ángel Basco-López and Helena Romay Barrero and Lisa Mailleux and Sofia Tatishvili and Anna Bedoshvili and Nino Valishvili and Martina Maselli and Giovanna De Luca and Corrado Claverini and Leopoldo Trieste and Giorgio Manfroni and Harold Bult and David Berghold and Iris Jakob and Alex Michael Pagnozzi and Jurgen Fripp and Kerstin Pannek and Els Ortibus and Antea Scrocco and Gemma D’alessandro and Giovanni Arras and Tommaso Turchi and Paolo Ferragina and Roslyn N Boyd and Silvia Filogna and Giuseppe Prencipe},
  journal = {BMJ Open},
  year = {2026},
  month = nov,
  doi = {10.1136/bmjopen-2026-117833},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-117833},
  note = {CC BY 4.0},
}

TY  - JOUR
TI  - Artificial Intelligence for developing a personalised functional profile and supporting upper-limb rehabilitation decision-making in children with unilateral Cerebral Palsy (AInCP): protocol for an observational study
AU  - Giuseppina Sgandurra
AU  - Alexandra Kalkantzi
AU  - Elena Beani
AU  - Giovanni Cioni
AU  - Rocio Palomo Carrión
AU  - Hilde Feys
AU  - Nana Nino Tatishvili
AU  - Matteo Cianchetti
AU  - Fiorella Battaglia
AU  - Giuseppe Turchetti
AU  - Wil Van Dommelen
AU  - Marco Pirini
AU  - Francesca Fedeli
AU  - Clara Bombonato
AU  - Maria Chiara Di Lieto
AU  - Benedetta Del Lucchese
AU  - Veronica Barzacchi
AU  - Valentina Menici
AU  - Annalisa Cotardo
AU  - Marta Rizzo
AU  - Eleonora Bieber
AU  - Pietro Ilio Gatti
AU  - Federica Camuncoli
AU  - Michela Tosetti
AU  - Paolo Bosco
AU  - Laura Biagi
AU  - Luca Peretti
AU  - Francy Cruz-Sanabria
AU  - Cristina Lirio-Romero
AU  - María Coello-Villalón
AU  - Purificación López-Muñoz
AU  - Julián Ángel Basco-López
AU  - Helena Romay Barrero
AU  - Lisa Mailleux
AU  - Sofia Tatishvili
AU  - Anna Bedoshvili
AU  - Nino Valishvili
AU  - Martina Maselli
AU  - Giovanna De Luca
AU  - Corrado Claverini
AU  - Leopoldo Trieste
AU  - Giorgio Manfroni
AU  - Harold Bult
AU  - David Berghold
AU  - Iris Jakob
AU  - Alex Michael Pagnozzi
AU  - Jurgen Fripp
AU  - Kerstin Pannek
AU  - Els Ortibus
AU  - Antea Scrocco
AU  - Gemma D’alessandro
AU  - Giovanni Arras
AU  - Tommaso Turchi
AU  - Paolo Ferragina
AU  - Roslyn N Boyd
AU  - Silvia Filogna
AU  - Giuseppe Prencipe
PY  - 2026
DA  - 2026/11/02
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-117833
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-117833
AB  - Introduction: Cerebral palsy (CP) is a lifelong non-progressive disorder, resulting from disturbances in the developing or infant brain, with approximately 17 million people worldwide being diagnosed. More than one-third of the population with CP has unilateral CP (UCP), whereby the primary sensorimotor impairments affect predominantly one side of the body, mainly the upper limb (UpL), compromising independence and quality of life. Associated comorbidities (eg, cognitive, visual, behavioural impairments and epilepsy) can impede the establishment of a clear functional diagnosis, consequently compromising the formation of effective intervention strategies. Driven by the clinical presentation complexity of UCP, the main objective of the Artificial Intelligence in Cerebral Palsy (AInCP) study is to establish a valid functional diagnosis supporting accurate rehabilitative priorities, identifying multidimensional functional profiles that may inform personalised rehabilitation planning, utilising AI. Through the integration of multimodal data, the ultimate goal is to develop and test evidence-based clinical decision support tools for the personalised functional diagnosis and UpL assessment in children with UCP by developing, testing and validating AI-cost-effective strategies. This will enable more accurate, personalised functional diagnoses and treatment planning, enhancing quality of life and efficiency of care for children with UCP.  Methods and analysis: This prospective, multicentre, observational clinical study will include 250 children with UCP and 250 typically developing children (TDC). Participants will be enrolled and assessed within four clinical centres distributed across Europe. Data from children with UCP will be collected by three broad domains: clinical assessments and questionnaires, neuroimaging data and data from UpL daily-life monitoring using wearable sensors. TDC will be evaluated using clinical tests and wearable sensors. All the items identified and the whole methodology have been co-created and co-designed among a multidisciplinary team, including caregivers and persons with lived experience. Data will be analysed with AI and machine-learning algorithms to understand the interdependencies across functional domains and create functional profiles that can guide personalised treatment planning. Non-clinical data such as sleep quality, technology familiarity and technology acceptance will also be collected to provide an empirical foundation for conducting an early health technology assessment of the solutions developed within the AInCP project.  Ethics and dissemination: Ethical approval has been obtained by all involved clinical sites. Written informed consent will be obtained from the legal representatives of all participating children, and age-appropriate assent will be obtained from children according to local ethical requirements. All procedures will be closely monitored by ethicists during the implementation of AI to ensure patient privacy, prevent bias and avoid unintended harm while developing robust, fair and trustworthy AI solutions. The results of this study will be disseminated through open-access peer-reviewed journals relevant for paediatrics to ensure wide accessibility. Results will be communicated by the professionals directly involved in the clinical study through national and international academic conferences, relevant associations and organisations, including policy makers.  Trial registration number: NCT06073522.
SN  - 2044-6055
SN  - 2044-6055
ER  -