Personalized Innovative Intervention Pathways to Promote EF in Children With CP

NCT ID: NCT06288971

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2027-03-01

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.

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; https://www.anastasis.it). The training will be conducted at home, 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. 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 ELLI's WORLD (https://www.anastasis.it/il-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, 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.

Conditions

Executive Functions in Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities

Intervention Type: OTHER

\- 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)).

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

Group Type: EXPERIMENTAL

Tele-rehabilitation of EF and specific cognitive processes underlying academic skills

Intervention Type: OTHER

\- 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.

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

Group Type: EXPERIMENTAL

Game-based tools for the rehabilitation of EF and motor planning

Intervention Type: OTHER

\- 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.

Typically developing children

Children aged 5 to 13 years old with no clinically documented disorders.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pisa

OTHER

Sponsor Role: collaborator

University of Florence

OTHER

Sponsor Role: collaborator

Anastasis Società Cooperativa Sociale

UNKNOWN

Sponsor Role: collaborator

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role: lead

Responsible Party

Giuseppina Sgandurra

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppina Sgandurra, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Fondazione Stella Maris

Locations

IRCCS Fondazione Stella Maris

Pisa, , Italy

Countries

Italy

Central Contacts

Giuseppina Sgandurra, MD, PhD

Role: CONTACT

g.sgandurra@fsm.unipi.it

3392472874

Maria Chiara Di Lieto, PhD

Role: CONTACT

3293676010

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Other Identifiers

IRCCS FSM

Identifier Type: -

Identifier Source: org_study_id