Personalized Innovative Intervention Pathways to Promote Executive Function in Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- changes in score of inhibition subtest at the NEPSY-II
Study Overview
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 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).
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 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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children with Cerebral Palsy:
- •Inclusion Criteria:
- •Children with confirmed diagnosis of CP
- •Ages from 5 to 13 years old
- •At least one cognitive index > 85 at WPPSI-IV or WISC-IV
- •Functional weakness in EF
Exclusion Criteria
- •Severe comorbidities and/or severe cognitive disability
- •For Typically developing children:
- •Ages from 5 to 13 years old
- •No documented clinically relevant disorders
Arms & Interventions
Children with impairment in EF and in visuo-spatial abilities
Children aged 5 to 13 years old with a diagnosis of Cerebral Palsy, with EF impairment and visuo-spatial difficulties
Intervention: Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities (Other)
Typically developing children
Children aged 5 to 13 years old with no clinically documented disorders.
Children with impairment in EF and in specific cognitive processes underlying academic skills
Children aged 5 to 13 years old with a diagnosis of Cerebral Palsy, with impairment in EF and in specific cognitive processes underlying academic skills
Intervention: Tele-rehabilitation of EF and specific cognitive processes underlying academic skills (Other)
Children with impairment in EF and in motor planning
Children aged 5 to 13 years old with a diagnosis of Cerebral Palsy, with impairment in EF and in motor planning
Intervention: Game-based tools for the rehabilitation of EF and motor planning (Other)
Outcomes
Primary Outcomes
changes in score of inhibition subtest at the NEPSY-II
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.
Secondary Outcomes
- changes in score of MOXO-continuous performance test(1-36 months)
- changes in score of Corsi block-tapping subtest at the BVS-corsi(1-36 months)
- changes in score of the sustained attention subtest at the Leiter-3(1-36 months)
- changes in score of reading and writing task at the DDE-2(1-36 months)
- changes in score of digit span forwards and backwards subtest at the BVN 5-11 and BVN 12-18(1-36 months)
- changes in score of Developmental Test of Visual-Motor Integration (VMI)(1-36 months)
- changes in score of RAN (rapid automatized naming) subtest at the rapid automatized naming and visual search of colours, figures and numbers test.(1-36 months)
- changes in score of Synthetic scale for the evaluation of writing in developmental age (BHK test)(1-36 months)
- changes in score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents(1-36 months)
- changes in score of reading and text comprehension task at the ALCE(1-36 months)
- changes in score of Go/No-Go and N-back 1 subtest at the teleFE(1-36 months)
- changes in score of Test of Visual Perception and Visuo-motor Integration (TPV)(1-36 months)
- changes in score of verbal fluency subtest at the NEPSY-II(1-36 months)
- changes in score of Praxic and Motor Coordination Skills-2nd Edition (APCM-2)(1-36 months)
- changes in score of Movement Assessment Battery for Children - Second Edition (Movement ABC-2)(1-36 months)
Investigators
Giuseppina Sgandurra
MD, PhD
IRCCS Fondazione Stella Maris