IRCCS Fondazione Stella Maris
Pisa, 56128, Italy
NCT Number: NCT06288971
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 skills,and/or 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).
Trial opening soon.
Get Notified5 year–13 year
All sexes
Interventional
Not applicable
Pisa, 56128, Italy
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 Miyake's 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 children's performance is used in several neurodevelopmental disorders for the treatment of motor, cognitive, learning and language impairments (e.g. Capodieci et al., 2022).
Game-based tools facilitate meaningful learning, through serious game activities exploiting playful elements and delivering continuous feedback on children's 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:
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:
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, https://ktarlow.com/stats/pnd). 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Children with Cerebral Palsy:
Inclusion criteria
Exclusion criteria
For Typically developing children:
Time frame: 1-36 months
In the study the investigators will assess the Inhibition subtest at the NEPSY-II (Urgesi et al., 2011). that valuates the ability to inhibit automatic responses in favour of novel responses and to switch between response types. It is divided into three conditions: naming, inhibition and switching. Both accuracy and speed are obtained for each condition, with standardised score range from 1 to 19. Higher scores revealed better performances.
Time frame: 1-36 months
In this study, the investigators will use the Sustained Attention subtest at the Leiter International Performance Scale (Leiter-3) (Roid et al., 2013), which assesses visual attention and consists of repetitive barrage tasks to be performed in a predefined time. The number of correctly selected target elements are recorded. Raw scores range from 0 to 217, while standardised score range from 1 to19. Higher scores revealed better performances.
Time frame: 1-36 months
VMI (Beery & Buktenica, 2000) is a paper-pencil test used to determine the level of integration between visual and motor systems. The child will be asked to copy different geometric forms shown on the paper within a certain time frame. The number of figures correctly reproduced is recorded and then converted in standardized scores. Raw scores range from 0 to 27. Higher scores reveal a better performance.
Time frame: 1-36 months
MOXO evaluates sustained attention and is provided via a computer. The test requires the child to sustain attention over a continuous stream of stimuli (visual or auditory) and to respond to a specific target stimulus. Four scales are extracted and converted in z scores: attentiveness, timeliness, impulsiveness, hyper-reactivity. Higher scores reveal a better performance.
Time frame: 1-36 months
The Corsi block-tapping subtest at the BVS-corsi (Mammarella et al., 2008) evaluates visuo-spatial short-term and working memory. The child is asked to retrieve a sequence previously seen by the examiner by tapping blocks with the preferred finger following the same order for the forward condition or reversing the order for the backward condition. The length of the last sequence correctly retrieved is recorded as the span, ranging from 3 to 8 in the forward condition and from 2 to 7 in the backward. Higher span reveals better performance.
Time frame: 1-36 months
BRIEF-P/2 (Gerard et al, 2016) is a questionnaire filled in by the parents/legal guardians and dives into everyday behaviour associated with specific domains of the executive functions (i.e., mental processes that enable us to plan, focus attention, remember instructions). Parents rate items (e.g., "does not think before doing") on a three-point scale ranging from 1 (never) to 3 (often). In the BRIEF 2 version, 9 scales are then extracted and converted in T scores: inhibition (ranging 8-24), self-monitoring (ranging 4-12), shift (ranging 8-24), emotional regulation (ranging 8-24), initiate (ranging 5-15), working memory (ranging 8-24), plan/organize (ranging 8-24), task monitoring (ranging 5-15), material organization (ranging 6-18); in the BRIEF P version, 5 scales are then extracted and converted in T scores: inhibition (ranging 16-48), shift (ranging 10-30), emotional regulation (ranging 10-30), working memory (ranging 17-51), plan/organize (ranging 10-30).
Time frame: 1-36 months
In the study the investigators will assess the subtest rapid visual naming (RAN) at the rapid automatized naming and visual search of colours, figures and numbers test (De Luca et al., 2005): the task consists in naming aloud all the stimuli contained in each matrix (colours, figures and numbers). For both tests time and number of errors are measured.
Time frame: 1-36 months
ALCE (Bonifacci et al., 2014) is a test for the evaluation of learning difficulties and for the evaluation of reading and comprehension skills. In the study the investigators will assess two subtests:
Time frame: 1-36 months
The battery for the Evaluation of Dyslexia and Developmental Dysortography-2 (DDE-2) (Sartori et al., 2007) is a test to evaluate reading and writing skills in children. In the study the investigators will assess two subtests:
Time frame: 1-36 months
In the study the investigators will assess the subtests digit span forwards and backwards at the BVN 5-11 (Bisiacchi et al., 2005) and BVN 12-18 (Gugliotta et al., 2009) for assess short-term and working memory, the child is asked to repeat the numbers spoken by the examiner following the same order for the forward condition or reversing the order for the backward condition. The length of the last sequence correctly retrieved is recorded as the span, ranging from 3 to 9 in the forward condition and from 2 to 8 in the backward. Higher span reveals better performance.
Time frame: 1-36 months
TeleFE (Cooperativa Sociale Anastasis) is a web platform for the multidimensional assessment of Executive Functions in developmental ages from 6 to 13 years. In the study the investigators will assess three subtests:
Both accuracy and speed are scored for each subtest, with percentile score. Higher scores revealed better performances.
Time frame: 1-36 months
In the study the investigators will assess the Verbal Fluency Subtest at the NEPSY-II (Urgesi et al., 2011), in which the child is asked to generate in one minutes as many words as possible from a given category (animals, food and drinks) or with an initial phoneme (F and S). The test evaluates lexical access and total number of correctly generated word is scored for both the semantic and the phonological condition. The standardised score range is from 1 to 19. Higher scores revealed better performances.
Time frame: 1-36 months
TPV (Hammill, 1994) is a test for the evaluation of visuo-perceptual and visuo-motor integration skills. In the study the investigators will assess the subtests:
From these four subtests, the visual-motor integration score can be calculated and converted into a percentile score. Higher scores revealed better performances.
Time frame: 1-36 months
APCM-2 (Sabbadini, 2015) aims to assess motor and praxis skills in children aged between 2-8 years, with age goup-specific performance tests.APCM-2 enables the early identification of deficits in motor-praxic coordination. The obtained scores facilitate a comprehensive assessment of each case, delineating the functional profile by calculating the deviation from the normative mean and referencing percentile values (5°, 10°, 25°). This approach aids in pinpointing specific functions for each scale, ranging from the most intact to the most impaired.
Time frame: 1-36 months
Movement ABC-2 (Henderson, 2013) evaluates movement difficulties in 3 to 16 years children and adolescents. This assessment battery examines motor difficulties in children and adolescents aged 3 to 16 years. Tasks are categorized by age group and distributed across three sections: manual dexterity, aiming and catching, and balance. Scores are presented in standard scores and percentiles, with interpretation facilitated by a traffic light system. A green light signifies typical motor performance (scores above the 15th percentile), a yellow light indicates a risk for motor impairment (scores between the 5th and 15th percentile), and a red light identifies a significant motor function impairment (scores below the 5th percentile).
Time frame: 1-36 months
The BHK test (Hamstra-Bletz et al., 2010) evaluates developmental dysgraphia, both the poor quality of the graphic sign (morphological analysis) and the disfluency (speed in the production of graphemes). Both accuracy and speed are evaluated with a z score and a percentile score, respectively. Higher scores reveal better performance.
Contact information is provided by the study sponsor or research team.
Giuseppina Sgandurra, MD, PhD
CONTACT
Maria Chiara Di Lieto, PhD
CONTACT
IRCCS Fondazione Stella Maris
Other
Personalized Innovative Intervention Pathways to Promote Executive Function in Children With Cerebral Palsy
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