Personalized Innovative Intervention Pathways to Promote EF in Children With CP
NCT06288971 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-03-01
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).
Conditions
- Executive Functions in Cerebral Palsy
Interventions
- OTHER
-
Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities
\- 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)).
- OTHER
-
Tele-rehabilitation of EF and specific cognitive processes underlying academic skills
\- 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.
- OTHER
-
Game-based tools for the rehabilitation of EF and motor planning
\- 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.
Sponsors & Collaborators
-
University of Pisa
collaborator OTHER -
University of Florence
collaborator OTHER -
Anastasis Società Cooperativa Sociale
collaborator UNKNOWN -
IRCCS Fondazione Stella Maris
lead OTHER
Principal Investigators
-
Giuseppina Sgandurra, MD, PhD · IRCCS Fondazione Stella Maris
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2027-01-31
- Completion
- 2027-03-01
Countries
- Italy
Study Locations
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