Personalized Innovative Intervention Pathways to Promote EF in Children With CP
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-13
SponsorIRCCS Fondazione Stella Maris
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Severe comorbidities and/or severe cognitive disability
Ages from 5 to 13 years old
No documented clinically relevant disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities
Other intervention\- Self-adaption web-based software integrated with neuropsychomotor activities in small groups to strengthen EF. The training will take place bi-weekly, for 3 months, for approximately 60 minutes per meeting. For the intervention will be used the Bee-bot, a robot to be programmed to achieve objectives set in space, allows 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)).
Tele-rehabilitation of EF and specific cognitive processes underlying academic skills
Other intervention\- Tele-rehabilitation intervention on FE (RuntheRAN and MemoRAN). The training will be conducted at home, with periodic meetings with the clinician, for 3 months, for approximately 4/5 days a week for approximately 30/40 minutes per day. An adult (e.g. a family member) will support the child in the treatment and ensure that the exercises are carried out adequately at home. One of the following tele-rehabilitation software will be used: RuntheRAN (RidiNet, Coopertiva Sociale 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 Sociale Anastasis), which involves rapid naming exercises of stimuli (figures and colors) presented in matrices, within tasks that require inhibition, cognitive flexibility and updating in working memory.
Game-based tools for the rehabilitation of EF and motor planning
Other intervention\- MondoELLI intervention (Cooperativa Sociale Anastasis) integrated with neuropsychomotor activities. The game-based app involves activities in small groups to strengthen various components of EF (interference control, inhibition, working memory, flexibility). The activities are organized with increasing difficulty, according to the self-adaptive algorithm, and within a narrative context.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Children with impairment in EF and in visuo-spatial abilitiesExperimental treatment 1 intervention
Group B: Children with impairment in EF and in specific cognitive processes underlying academic skillsExperimental treatment 1 intervention
Group C: Children with impairment in EF and in motor planningExperimental treatment 1 intervention
Group D: Typically developing childrenNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
changes in score of inhibition subtest at the NEPSY-II
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 monthsSecondary outcomes
1
changes in score of the sustained attention subtest at the Leiter-3
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 months2
changes in score of Developmental Test of Visual-Motor Integration (VMI)
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 months3
changes in score of MOXO-continuous performance test
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 months4
changes in score of Corsi block-tapping subtest at the BVS-corsi
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS Fondazione Stella Maris
Lead sponsor
University of Pisa
Collaborator
University of Florence
Collaborator
Anastasis Società Cooperativa Sociale
Collaborator
Source ClinicalTrials.gov
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