Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288971
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-26
Brief Title:
Personalized Innovative Intervention Pathways to Promote EF in Children With CP
Sponsor:
IRCCS Fondazione Stella Maris
Organization:
IRCCS Fondazione Stella Maris
Study Overview
Official Title:
Personalized Innovative Intervention Pathways to Promote Executive Function in Children With Cerebral Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Cerebral palsy CP is an umbrella term covering a group of disorders of movement and posture It is now accepted that CP represents much more than a disorder of movements considering the frequent association with a broad range of impairments including cognitive impairments In general multiple clinical characteristics that define and determine different functional profiles Several studies on children with unilateral and bilateral CP have been shown that despite the overall preserved intellectual functioning there are specific neuropsychological impairments distinguishing the two forms including deficits in different Executive Functions EF components Executive Functions EFs represent a complex cognitive domain consisting of a set of top-down functions essential for adaptive goal-directed behaviour allowing to formulate plan and organise ideas cope with challenges and novelties resist temptations and stay focused EF represents general domain abilities transversal to several cognitive processes and underling different daily life activities and school learning skills Empowering EF becomes therefore crucial in children with CP both to strengthen specific functional EF weaknesses and to achieve far transfer effects on other compromised domains such as motor planning academic skillsandor visuospatial processing To pursue this the EF training needs to be integrated into the complex and multidisciplinary care context promoting innovative intervention methodologies based on scientific evidence Recent researches and clinical practice carried out in our Institute supports the effectiveness of innovative interventions on EF using new technologies in typical and atypical development such as Self-adapting web based softwares Game-based tools or Educational Robotics Literature suggests these technologies allow to promote timely intervention within a user-friendly context while respecting the key criteria of evidence-based neuropsychological rehabilitation both reducing hospitalisation times and supporting interest and motivation for participation The primary aim of this study is to evaluate the applicability of technological intervention integrated with psychomotor activities to promote EF and then secondary to measure the effect on the functional profile of children with CP including motor planning visuo-spatial processing and learning skills evaluating both short-term T2 and long-term changes T3
Detailed Description:
Cerebral Palsy CP is an umbrella term covering a group of permanent disorders of movement and posture development causing activity limitation It is now widely accepted that CP motor disorders are frequently associated with a broad range of functional impairments including cognitive and neuropsychological functions The presence of epilepsy premature birth low birth weight reduced fetal growth lesion characteristics and severe gross motor impairment are significant risk factors for cognitive deficit development Due to the great heterogeneity of the clinical pictures which depend on the extent magnitude and timing of the lesion it is possible to distinguish different forms of CP International Classification of 2013 spastic forms approx 90 of total cases dyskinetic and ataxic forms Research indicates a better functional outcome in children with spastic hemiplegia and diplegia compared to those with tetraplegic and ataxic CP where severe intellectual deficits are more commonly reported although significant challenges in the standardized assessment of these children are due to more severe motor and oro-motor impairment Ballester-Plane et al 2018 A more substantial number of studies have been conducted on children with spastic hemiplegia and diplegia revealing that despite overall preserved intellectual functioning there are specific neuropsychological impairments distinguishing unilateral and bilateral CP Deficits in different Executive functions EF components playing an important role in behaviour regulation problem solving social abilities and the successful completion of everyday activities are also often reported in literature One of the reference theoretical models for EFs is the one proposed by Adele Diamond who starting from Miyakes fractional model described EFs as made up of three main components inhibitory control working memory and cognitive flexibility which allow the structuring of higher order EFs reasoning planning and problem solving Several studies have identified a close association between EF and other domains considering such processes as transversal to several cognitive and motor functions also underlying different daily life activities and school learning skills such as mathematics reading or writing The role of specific training on EF becomes crucial in children with CP both to strengthen specific EF weaknesses and to achieve generalised benefits in other compromised domains such as motor planning visuospatial processing or academic achievements To pursue this the training needs to be integrated into the complex and multidisciplinary care context in which the child with neuromotor disorder is already placed Recent years have seen the spread of innovative rehabilitation methods such as Self-adapting web-based software Game-based systems or Educational Robotics Literature suggests these technologies have the advantage of intervening in a timely manner within a home-based context while following the the key criteria of evidence-based neuropsychological rehabilitation intensity self-adaptivity of the exercise and planning fun enjoyable and motivating activities In particular Self-adapting web-based software improving the difficulties of the activities delivered according to the childrens performance is used in several neurodevelopmental disorders for the treatment of motor cognitive learning and language impairments eg Capodieci et al 2022
Game-based tools facilitate meaningful learning through serious game activities exploiting playful elements and delivering continuous feedback on childrens performance As its video-game nature the difficulty is adapted to the children skills and rises progressively according to the learning aims Educational Robotic ER refers to a learning approach requiring children to design assemble and program robots through play and hands-on activities Robot programming may be a tool to increase problem solving skills cognitive flexibility and inhibition in both typical and atypical development Di Lieto et al 2019 and 2020 It is possible to profitably use all of these tools in children with Cerebral Palsy CP considering their neuropsychological and motor function impairments
The aim of this study is to evaluate the applicability and effect of technological intervention integrated with psychomotor activities to promote EF and secondary the impact on academic skills and motor planning in children with CP evaluating both short-term T2 and long-term changes T3 More specific outcomes will be
To verify the feasibility of using new intervention technologies adopting intensive and self-adaptive methodologies and encouraging interaction and learning between peers
To build three personalised intervention protocols based on the different neuropsychological profiles
To analyse the effect of such intervention on the EF directly targeted
To evaluate the generalised effect of the EF intervention on other domains such as academic skills visuo-spatial processing and motor planning
Both short-term T2 and long-term T3 changes will be considered
The attribution to the following treatment paths will not be completely randomised because based on specific children rehabilitation needs both considering age and neuropsychological profile
Educational Robotics integrated with psychomotor activities ERi in small groups to strengthen EF The training will take place bi-weekly for 3 months for approximately 60 minutes per meeting For Educational Robotics will be used the Bee-bot a robot bee-like to program its movement using some directional buttons on the back in order to achieve and reach objectives set in space therefore allowing to stimulate navigation visuospatial working memory and planning skills the activities will be taken from those already used in our previous studies in children with typical development and BES Di Lieto et al 2020
Self-adaptive web-based software on EF RuntheRAN and MemoRAN httpswwwanastasisit The training will be conducted at home for 3 months for approximately 45 days a week for approximately 3040 minutes per day An adult eg a family member will support the child in the treatment and ensure that the exercises are carried out adequately at home The clinician can monitor and control the intervention progress also intervening manually on the auto-adaptation both in online sessions and offline For the intervention will be used RuntheRAN RidiNet Coopertiva Anastasis a software that aims to strengthen the prerequisites of reading by requiring the timed and progressively faster naming of colour matrices or black and white figures MemoRAN RidiNet Cooperativa Anastasis which involves rapid naming exercises of stimuli figures and colours presented in matrices within tasks that require inhibition cognitive flexibility and updating in working memory
The ELLIs WORLD httpswwwanastasisitil-mondo-degli-elli integrated with psychomotor activities The game-based app involves activities in small groups to promote various components of EF interference control inhibition working memory flexibility The activities are organised with increasing difficulty according to the self-adaptive algorithm and within a narrative context
The clinical sample will be evaluated at different times during the study period T1 T2 T3
The study involves 3 functional assessments pre-training T1 after 3 months from T1 assessment for post-training T2 and after 6 months from T2 assessment for follow-up T3
The short-term effect of the treatment will be evaluated by comparing pre- post assessment and the degree of improvement during the training Percentage of Nonoverlapping Data httpsktarlowcomstatspnd The long-term effect will be analysed 6 months after the end of the intervention by comparing the performances post intervention with those at the follow-up
Game-based tools facilitate meaningful learning through serious game activities exploiting playful elements and delivering continuous feedback on childrens performance As its video-game nature the difficulty is adapted to the children skills and rises progressively according to the learning aims Educational Robotic ER refers to a learning approach requiring children to design assemble and program robots through play and hands-on activities Robot programming may be a tool to increase problem solving skills cognitive flexibility and inhibition in both typical and atypical development Di Lieto et al 2019 and 2020 It is possible to profitably use all of these tools in children with Cerebral Palsy CP considering their neuropsychological and motor function impairments
The aim of this study is to evaluate the applicability and effect of technological intervention integrated with psychomotor activities to promote EF and secondary the impact on academic skills and motor planning in children with CP evaluating both short-term T2 and long-term changes T3 More specific outcomes will be
To verify the feasibility of using new intervention technologies adopting intensive and self-adaptive methodologies and encouraging interaction and learning between peers
To build three personalised intervention protocols based on the different neuropsychological profiles
To analyse the effect of such intervention on the EF directly targeted
To evaluate the generalised effect of the EF intervention on other domains such as academic skills visuo-spatial processing and motor planning
Both short-term T2 and long-term T3 changes will be considered
The attribution to the following treatment paths will not be completely randomised because based on specific children rehabilitation needs both considering age and neuropsychological profile
Educational Robotics integrated with psychomotor activities ERi in small groups to strengthen EF The training will take place bi-weekly for 3 months for approximately 60 minutes per meeting For Educational Robotics will be used the Bee-bot a robot bee-like to program its movement using some directional buttons on the back in order to achieve and reach objectives set in space therefore allowing to stimulate navigation visuospatial working memory and planning skills the activities will be taken from those already used in our previous studies in children with typical development and BES Di Lieto et al 2020
Self-adaptive web-based software on EF RuntheRAN and MemoRAN httpswwwanastasisit The training will be conducted at home for 3 months for approximately 45 days a week for approximately 3040 minutes per day An adult eg a family member will support the child in the treatment and ensure that the exercises are carried out adequately at home The clinician can monitor and control the intervention progress also intervening manually on the auto-adaptation both in online sessions and offline For the intervention will be used RuntheRAN RidiNet Coopertiva Anastasis a software that aims to strengthen the prerequisites of reading by requiring the timed and progressively faster naming of colour matrices or black and white figures MemoRAN RidiNet Cooperativa Anastasis which involves rapid naming exercises of stimuli figures and colours presented in matrices within tasks that require inhibition cognitive flexibility and updating in working memory
The ELLIs WORLD httpswwwanastasisitil-mondo-degli-elli integrated with psychomotor activities The game-based app involves activities in small groups to promote various components of EF interference control inhibition working memory flexibility The activities are organised with increasing difficulty according to the self-adaptive algorithm and within a narrative context
The clinical sample will be evaluated at different times during the study period T1 T2 T3
The study involves 3 functional assessments pre-training T1 after 3 months from T1 assessment for post-training T2 and after 6 months from T2 assessment for follow-up T3
The short-term effect of the treatment will be evaluated by comparing pre- post assessment and the degree of improvement during the training Percentage of Nonoverlapping Data httpsktarlowcomstatspnd The long-term effect will be analysed 6 months after the end of the intervention by comparing the performances post intervention with those at the follow-up
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