Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06073522
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-10-04
Brief Title:
Validation of AI for Personalized Assessment and Rehabilitation of Upper Limb in Children With Unilateral Cerebral Palsy
Sponsor:
IRCCS Fondazione Stella Maris
Organization:
IRCCS Fondazione Stella Maris
Study Overview
Official Title:
Clinical Validation of Artificial INtelligence for Providing a Personalized Motor Clinical Profile Assessment and Rehabilitation of Upper Limb in Children With Unilateral Cerebral Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AInCP
Brief Summary:
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
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
Detailed Description:
The project is configured as an international observational clinical non-profit study that aims to change the current management of care and intervention of children and adolescents with UCP providing a new model of approach
This study has international dimensions in fact it involves 12 partners from 7 countries children will be enrolled and tested by the four clinical centers namely the IRCCS Stella Maris Foundation the Universidad De Castilla - La Mancha Spain the Katholieke Universiteit of Leuven Belgium and the David Tvildiani Medical University Georgia
Enrollment and clinical and kinematic evaluations will be carried out by the centers involved in the study as regards the analysis of all neuroimaging data the Queensland Cerebral Palsy Research Centre of the University of Queensland Australia will be involved as this center is an international expert on this
Participation in the study will be voluntary and a signature of informed consent by the parent will be required
For the group of children with UCP the inclusion criteria will be
1 Confirmed diagnosis of CP with predominantly spastic hemiplegia
2 Mild to moderately severe impairment of upper limb function MACS level I-III
The exclusion criteria will be
1 Severe impairment of the upper limbs MACS level IV or V
2 Botulinum toxin injection in the upper limb within 6 months prior to study entry
3 Upper limb surgery in the 6 months prior to study entry
4 Presence of severe comorbidities andor severe intellectual disability For the sample of children with typical development they will be defined with the exclusion criteria of clinically documented disorders
Recruitment will take place only after the signature of the informed consent Upon recruitment some personal data will be acquired and a special database will be created built on the REDCap platform and processed anonymously
The data will come from the following areas
1 Multiaxial clinical assessments and questionnaires
Before the start of the evaluation a screening of the clinical measures that are part of the protocol will be carried out in order to report any recent administrations of the same tests in order to if necessary choose a better time window in which to start participation in this study The protocol is in fact composed of standardized tests and questionnaires usually used in clinical practice The clinical evaluation which will be organized in two consecutive days and will be divided into different tests some directed to the child and others such as questionnaires carried out by with the parents included in the following areas
Clinical motor evaluation strength spasticity and mirror movements and sensitivity
Evaluation of the functionality of the upper limbs with structured and semi-structured tests
Cognitive and neuropsychological evaluation
Classification systems and questionnaires for upper limb skills independence in everyday life and aspects related to participation and quality of life
For the children with TD only a very small part of the evaluations provided for children with UCP will be carried out that is
Evaluation of upper limb function with a semi-structured assessment session
Questionnaires for coordination skills to define laterality and to explore aspects related to behavior
Finally a survey will be proposed consisting of questionnaires on sleep quality quality of life and familiarity and ability with technologies for all children both those with UCP and those with TD their parents and also health professionals
2 Neuroimaging Structural Magnetic Resonance MRI images of the brain of children with UCP commonly acquired for clinical purposes will be collected and evaluated according to the semiquantitative evaluation scale developed by the Stella Maris Foundation FSM in order to quantify the severity of brain injury For children andor adolescents who have already performed MRI parental consent will be requested to access this data Image evaluation will be carried out by anonymizing and transferring the images to the University of QueenslandCSIRO in Australia and then analysed by expert evaluators using automated software producing quantitative measurements
3 Analysis of upper limb movement during clinical evaluation and daily life All children andor adolescents enrolled will be asked to wear sensors on both wrists during clinical evaluations and for 2 weeks in order to investigate upper limb activity also during daily life During this period parents will have to fill out a diary reporting the main daily activities for example the time of wake-up falling asleep lunch and dinner any sporting activity etc Questionnaires will also be administered to evaluate the feasibility and acceptability of the sensors by children andor adolescents and their parents with a short daily form and a more extensive form at the end of the period of recording At the end of the 2 weeks parents will be contacted to pick up the sensors directly from their home
To protect privacy and anonymity each subject will be assigned a numerical code that will be kept separately In this way the database will not contain any identification data of the subject Access to such data will be limited only to personnel directly involved in the study and all data will be processed anonymously
Once all the data coming from the three domains clinical assessment neuroimaging and kinematic analysis together with the questionnaires will be collected they will be inserted in a dedicated RedCap database
Investigators of UNIPI will use AI algorithms to process and analyze all data collected at the Green Data Center clinical outcome measures trackers data results of the questionnaires and the outcome from neuroimaging analysis The results of analysis will be packaged into the diagnostic Decision Support Tool dDST a software tool that will support clinicians in managing functional diagnosis This tool will be accessed by the clinicians through a specifically designed dashboard The purpose of the AI analysis is to understand how these data are correlated with the different clinical features and treatment responses that distinguish one individual from another The clinician can be supported both in diagnostic and rehabilitative processes positively impacting both the clinical decision-making and the subject healthcare
This study has international dimensions in fact it involves 12 partners from 7 countries children will be enrolled and tested by the four clinical centers namely the IRCCS Stella Maris Foundation the Universidad De Castilla - La Mancha Spain the Katholieke Universiteit of Leuven Belgium and the David Tvildiani Medical University Georgia
Enrollment and clinical and kinematic evaluations will be carried out by the centers involved in the study as regards the analysis of all neuroimaging data the Queensland Cerebral Palsy Research Centre of the University of Queensland Australia will be involved as this center is an international expert on this
Participation in the study will be voluntary and a signature of informed consent by the parent will be required
For the group of children with UCP the inclusion criteria will be
1 Confirmed diagnosis of CP with predominantly spastic hemiplegia
2 Mild to moderately severe impairment of upper limb function MACS level I-III
The exclusion criteria will be
1 Severe impairment of the upper limbs MACS level IV or V
2 Botulinum toxin injection in the upper limb within 6 months prior to study entry
3 Upper limb surgery in the 6 months prior to study entry
4 Presence of severe comorbidities andor severe intellectual disability For the sample of children with typical development they will be defined with the exclusion criteria of clinically documented disorders
Recruitment will take place only after the signature of the informed consent Upon recruitment some personal data will be acquired and a special database will be created built on the REDCap platform and processed anonymously
The data will come from the following areas
1 Multiaxial clinical assessments and questionnaires
Before the start of the evaluation a screening of the clinical measures that are part of the protocol will be carried out in order to report any recent administrations of the same tests in order to if necessary choose a better time window in which to start participation in this study The protocol is in fact composed of standardized tests and questionnaires usually used in clinical practice The clinical evaluation which will be organized in two consecutive days and will be divided into different tests some directed to the child and others such as questionnaires carried out by with the parents included in the following areas
Clinical motor evaluation strength spasticity and mirror movements and sensitivity
Evaluation of the functionality of the upper limbs with structured and semi-structured tests
Cognitive and neuropsychological evaluation
Classification systems and questionnaires for upper limb skills independence in everyday life and aspects related to participation and quality of life
For the children with TD only a very small part of the evaluations provided for children with UCP will be carried out that is
Evaluation of upper limb function with a semi-structured assessment session
Questionnaires for coordination skills to define laterality and to explore aspects related to behavior
Finally a survey will be proposed consisting of questionnaires on sleep quality quality of life and familiarity and ability with technologies for all children both those with UCP and those with TD their parents and also health professionals
2 Neuroimaging Structural Magnetic Resonance MRI images of the brain of children with UCP commonly acquired for clinical purposes will be collected and evaluated according to the semiquantitative evaluation scale developed by the Stella Maris Foundation FSM in order to quantify the severity of brain injury For children andor adolescents who have already performed MRI parental consent will be requested to access this data Image evaluation will be carried out by anonymizing and transferring the images to the University of QueenslandCSIRO in Australia and then analysed by expert evaluators using automated software producing quantitative measurements
3 Analysis of upper limb movement during clinical evaluation and daily life All children andor adolescents enrolled will be asked to wear sensors on both wrists during clinical evaluations and for 2 weeks in order to investigate upper limb activity also during daily life During this period parents will have to fill out a diary reporting the main daily activities for example the time of wake-up falling asleep lunch and dinner any sporting activity etc Questionnaires will also be administered to evaluate the feasibility and acceptability of the sensors by children andor adolescents and their parents with a short daily form and a more extensive form at the end of the period of recording At the end of the 2 weeks parents will be contacted to pick up the sensors directly from their home
To protect privacy and anonymity each subject will be assigned a numerical code that will be kept separately In this way the database will not contain any identification data of the subject Access to such data will be limited only to personnel directly involved in the study and all data will be processed anonymously
Once all the data coming from the three domains clinical assessment neuroimaging and kinematic analysis together with the questionnaires will be collected they will be inserted in a dedicated RedCap database
Investigators of UNIPI will use AI algorithms to process and analyze all data collected at the Green Data Center clinical outcome measures trackers data results of the questionnaires and the outcome from neuroimaging analysis The results of analysis will be packaged into the diagnostic Decision Support Tool dDST a software tool that will support clinicians in managing functional diagnosis This tool will be accessed by the clinicians through a specifically designed dashboard The purpose of the AI analysis is to understand how these data are correlated with the different clinical features and treatment responses that distinguish one individual from another The clinician can be supported both in diagnostic and rehabilitative processes positively impacting both the clinical decision-making and the subject healthcare
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None