Executive Functions in Cerebral PalsyNCT06288971
Personalized Innovative Intervention Pathways to Promote EF in Children With CP
A study testing Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities, Tele-rehabilitation of EF and specific cognitive processes underlying academic skills and Game-based tools for the rehabilitation of EF and motor planning in people with Executive Functions in Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Functions in Cerebral Palsy
- What is being tested?
- Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities, Tele-rehabilitation of EF and specific cognitive processes underlying academic skills and Game-based tools for the rehabilitation of EF and motor planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Severe comorbidities and/or severe cognitive disability
- For Typically developing children:
- Ages from 5 to 13 years old
- No documented clinically relevant disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Chiara Di Lieto, PhD contact
About this study
Official title: Personalized Innovative Intervention Pathways to Promote Executive Function in Children With Cerebral Palsy
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).
Read the 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
- Being tested
- Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities, Tele-rehabilitation of EF and specific cognitive processes underlying academic skills, Game-based tools for the rehabilitation of EF and motor planning
- Keywords
- Cerebral Palsy, Executive Function, Neuropsychological Evaluation, Neuropsychological Rehabilitation, Educational Robotics, Game-based System, Instrumental School Learning Skills
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilitiesOther
- 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 skillsOther
- 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 planningOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Children with impairment in EF and in visuo-spatial abilities | Experimental | Children aged 5 to 13 years old with a diagnosis of Cerebral Palsy, with EF impairment and visuo-spatial difficulties Receives: Other: Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities |
| Children with impairment in EF and in specific cognitive processes underlying academic skills | Experimental | 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 Receives: Other: Tele-rehabilitation of EF and specific cognitive processes underlying academic skills |
| Children with impairment in EF and in motor planning | Experimental | Children aged 5 to 13 years old with a diagnosis of Cerebral Palsy, with impairment in EF and in motor planning Receives: Other: Game-based tools for the rehabilitation of EF and motor planning |
| Typically developing children | No intervention | Children aged 5 to 13 years old with no clinically documented disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-36 months
Secondary outcomes (15)
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.
Measured: 1-36 months
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.
Measured: 1-36 months
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.
Measured: 1-36 months
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.
Measured: 1-36 months
changes in score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents
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).
Measured: 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.
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.
Measured: 1-36 months
changes in score of reading and text comprehension task at the ALCE
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:
- Reading of the passage (in which the child is asked to read a passage, considering speed and correctness).
- Reading comprehension (in which the comprehension skills of a read text are tested).
Measured: 1-36 months
changes in score of reading and writing task at the DDE-2
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:
- Test 2 and 3 (reading words and non-words, in which the child is asked to read aloud as quickly and as accurately as possible 4 lists of 28 concrete and abstract words with high or low frequency and 3 lists of 16 non-words, in line with the phonotactic and phonographic rules of the Italian language).
- Test 6 and 7 (writing words and non-words under dictation, in which the child is asked to write 48 concrete and abstract words with high or low frequency and 24 non-words).
Measured: 1-36 months
changes in score of digit span forwards and backwards subtest at the BVN 5-11 and BVN 12-18
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.
Measured: 1-36 months
changes in score of Go/No-Go and N-back 1 subtest at the teleFE
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:
- In the go/no-go subtest children are asked to press a button when they see only the target stimulus between distracting stimuli that appear on the screen.
- In subtest n-back 1, children are asked to remember the same item as the previous one within a string of stimuli that appear on the screen.
Both accuracy and speed are scored for each subtest, with percentile score. Higher scores revealed better performances.
Measured: 1-36 months
changes in score of verbal fluency subtest at the NEPSY-II
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.
Measured: 1-36 months
changes in score of Test of Visual Perception and Visuo-motor Integration (TPV)
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:
- Copying\ reproduction Subtest: the child sees figures that he must copy
- Visual\motor speed: the child is asked to draw distinctive designs inside the target figures.
- Hand-eye coordination: the child is asked to draw some lines inside bands of different widths.
- Spatial relationships: the child is asked to connect some dots to reproduce the target figure.
From these four subtests, the visual-motor integration score can be calculated and converted into a percentile score. Higher scores revealed better performances.
Measured: 1-36 months
changes in score of Praxic and Motor Coordination Skills-2nd Edition (APCM-2)
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.
Measured: 1-36 months
changes in score of Movement Assessment Battery for Children - Second Edition (Movement ABC-2)
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).
Measured: 1-36 months
changes in score of Synthetic scale for the evaluation of writing in developmental age (BHK test)
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.
Measured: 1-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Executive Functions in Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa, University of Florence, Anastasis Società Cooperativa Sociale
- Responsible party
- Principal investigator, Giuseppina Sgandurra, IRCCS Fondazione Stella Maris
- Investigators
- Giuseppina Sgandurra, MD, PhD, Principal investigator, IRCCS Fondazione Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288971
- Sponsor's protocol ID
- IRCCS FSM
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fluss J, Lidzba K. Cognitive and academic profiles in children with cerebral palsy: A narrative review. Ann Phys Rehabil Med. 2020 Oct;63(5):447-456. doi: 10.1016/j.rehab.2020.01.005. Epub 2020 Feb 19.
PubMed 32087307Zoccolotti P, Cantagallo A, De Luca M, Guariglia C, Serino A, Trojano L. Selective and integrated rehabilitation programs for disturbances of visual/spatial attention and executive function after brain damage: a neuropsychological evidence-based review. Eur J Phys Rehabil Med. 2011 Mar;47(1):123-47.
PubMed 21448124Diamond A, Ling DS. Conclusions about interventions, programs, and approaches for improving executive functions that appear justified and those that, despite much hype, do not. Dev Cogn Neurosci. 2016 Apr;18:34-48. doi: 10.1016/j.dcn.2015.11.005. Epub 2015 Dec 7.
PubMed 26749076Di Lieto MC, Castro E, Pecini C, Inguaggiato E, Cecchi F, Dario P, Cioni G, Sgandurra G. Improving Executive Functions at School in Children With Special Needs by Educational Robotics. Front Psychol. 2020 Jan 9;10:2813. doi: 10.3389/fpsyg.2019.02813. eCollection 2019.
PubMed 31998169Pecini C, Spoglianti S, Bonetti S, Di Lieto MC, Guaran F, Martinelli A, Gasperini F, Cristofani P, Casalini C, Mazzotti S, Salvadorini R, Bargagna S, Palladino P, Cismondo D, Verga A, Zorzi C, Brizzolara D, Vio C, Chilosi AM. Training RAN or reading? A telerehabilitation study on developmental dyslexia. Dyslexia. 2019 Aug;25(3):318-331. doi: 10.1002/dys.1619. Epub 2019 May 23.
PubMed 31124262Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
PubMed 23020641Di Lieto MC, Brovedani P, Pecini C, Chilosi AM, Belmonti V, Fabbro F, Urgesi C, Fiori S, Guzzetta A, Perazza S, Sicola E, Cioni G. Spastic diplegia in preterm-born children: Executive function impairment and neuroanatomical correlates. Res Dev Disabil. 2017 Feb;61:116-126. doi: 10.1016/j.ridd.2016.12.006. Epub 2017 Jan 7.
PubMed 28073076Pirila S, van der Meere J, Korhonen P, Ruusu-Niemi P, Kyntaja M, Nieminen P, Korpela R. A retrospective neurocognitive study in children with spastic diplegia. Dev Neuropsychol. 2004;26(3):679-90. doi: 10.1207/s15326942dn2603_2.
PubMed 15525564Schatz J, Craft S, White D, Park TS, Figiel GS. Inhibition of return in children with perinatal brain injury. J Int Neuropsychol Soc. 2001 Mar;7(3):275-84. doi: 10.1017/s1355617701733012.
PubMed 11311028Bodimeade HL, Whittingham K, Lloyd O, Boyd RN. Executive function in children and adolescents with unilateral cerebral palsy. Dev Med Child Neurol. 2013 Oct;55(10):926-33. doi: 10.1111/dmcn.12195. Epub 2013 Jun 28.
PubMed 23809003Pirila S, van der Meere JJ, Rantanen K, Jokiluoma M, Eriksson K. Executive functions in youth with spastic cerebral palsy. J Child Neurol. 2011 Jul;26(7):817-21. doi: 10.1177/0883073810392584. Epub 2011 Mar 11.
PubMed 21398561Critten V, Messer D, Sheehy K. Delays in the reading and spelling of children with cerebral palsy: Associations with phonological and visual processes. Res Dev Disabil. 2019 Feb;85:131-142. doi: 10.1016/j.ridd.2018.12.001. Epub 2018 Dec 13.
PubMed 30553174Cantin RH, Gnaedinger EK, Gallaway KC, Hesson-McInnis MS, Hund AM. Executive functioning predicts reading, mathematics, and theory of mind during the elementary years. J Exp Child Psychol. 2016 Jun;146:66-78. doi: 10.1016/j.jecp.2016.01.014. Epub 2016 Feb 23.
PubMed 26914106Cartwright KB, Marshall TR, Huemer CM, Payne JB. Executive function in the classroom: Cognitive flexibility supports reading fluency for typical readers and teacher-identified low-achieving readers. Res Dev Disabil. 2019 May;88:42-52. doi: 10.1016/j.ridd.2019.01.011. Epub 2019 Mar 6.
PubMed 30851482Garcia-Galant M, Blasco M, Reid L, Pannek K, Leiva D, Laporta-Hoyos O, Ballester-Plane J, Miralbell J, Caldu X, Alonso X, Toro-Tamargo E, Melendez-Plumed M, Gimeno F, Coronas M, Soro-Camats E, Boyd R, Pueyo R. Study protocol of a randomized controlled trial of home-based computerized executive function training for children with cerebral palsy. BMC Pediatr. 2020 Jan 7;20(1):9. doi: 10.1186/s12887-019-1904-x.
PubMed 31910803
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Innovative Intervention Pathways to Promote Executive Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06288971
- Acronym / sponsor ID
- IRCCS FSM
- Conditions
- Executive Functions in Cerebral Palsy
- Keywords
- Cerebral Palsy, Executive Function, Neuropsychological Evaluation, Neuropsychological Rehabilitation, Educational Robotics, Game-based System, Instrumental School Learning Skills
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- University of Pisa, University of Florence, Anastasis Società Cooperativa Sociale
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children with impairment in EF and in visuo-spatial abilities | Experimental | Other: Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilitiesChildren aged 5 to 13 years old with a diagnosis of Cerebral Palsy, with EF impairment and visuo-spatial difficulties |
| Children with impairment in EF and in specific cognitive processes underlying academic skills | Experimental | Other: Tele-rehabilitation of EF and specific cognitive processes underlying academic skillsChildren aged 5 to 13 years old with a diagnosis of Cerebral Palsy, with impairment in EF and in specific cognitive processes underlying academic skills |
| Children with impairment in EF and in motor planning | Experimental | Other: Game-based tools for the rehabilitation of EF and motor planningChildren aged 5 to 13 years old with a diagnosis of Cerebral Palsy, with impairment in EF and in motor planning |
| Typically developing children | No intervention | –Children aged 5 to 13 years old with no clinically documented disorders. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Severe comorbidities and/or severe cognitive disability
- Ages from 5 to 13 years old
- No documented clinically relevant disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Children with impairment in EF and in visuo-spatial abilities |
| 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 | Children with impairment in EF and in specific cognitive processes underlying academic skills |
| 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. | Other | Children with impairment in EF and in motor planning |
Primary outcome
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.
15 secondary outcomes
changes in score of the sustained attention subtest at the Leiter-3
Time frame: 1-36 months
changes in score of Developmental Test of Visual-Motor Integration (VMI)
Time frame: 1-36 months
changes in score of MOXO-continuous performance test
Time frame: 1-36 months
changes in score of Corsi block-tapping subtest at the BVS-corsi
Time frame: 1-36 months
changes in score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents
Time frame: 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.
Time frame: 1-36 months
changes in score of reading and text comprehension task at the ALCE
Time frame: 1-36 months
changes in score of reading and writing task at the DDE-2
Time frame: 1-36 months
changes in score of digit span forwards and backwards subtest at the BVN 5-11 and BVN 12-18
Time frame: 1-36 months
changes in score of Go/No-Go and N-back 1 subtest at the teleFE
Time frame: 1-36 months
changes in score of verbal fluency subtest at the NEPSY-II
Time frame: 1-36 months
changes in score of Test of Visual Perception and Visuo-motor Integration (TPV)
Time frame: 1-36 months
changes in score of Praxic and Motor Coordination Skills-2nd Edition (APCM-2)
Time frame: 1-36 months
changes in score of Movement Assessment Battery for Children - Second Edition (Movement ABC-2)
Time frame: 1-36 months
changes in score of Synthetic scale for the evaluation of writing in developmental age (BHK test)
Time frame: 1-36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 32087307Fluss J, Lidzba K. Cognitive and academic profiles in children with cerebral palsy: A narrative review. Ann Phys Rehabil Med. 2020 Oct;63(5):447-456. doi: 10.1016/j.rehab.2020.01.005. Epub 2020 Feb 19.
- Background: PubMed 21448124Zoccolotti P, Cantagallo A, De Luca M, Guariglia C, Serino A, Trojano L. Selective and integrated rehabilitation programs for disturbances of visual/spatial attention and executive function after brain damage: a neuropsychological evidence-based review. Eur J Phys Rehabil Med. 2011 Mar;47(1):123-47.
- Background: PubMed 26749076Diamond A, Ling DS. Conclusions about interventions, programs, and approaches for improving executive functions that appear justified and those that, despite much hype, do not. Dev Cogn Neurosci. 2016 Apr;18:34-48. doi: 10.1016/j.dcn.2015.11.005. Epub 2015 Dec 7.
- Background: PubMed 31998169Di Lieto MC, Castro E, Pecini C, Inguaggiato E, Cecchi F, Dario P, Cioni G, Sgandurra G. Improving Executive Functions at School in Children With Special Needs by Educational Robotics. Front Psychol. 2020 Jan 9;10:2813. doi: 10.3389/fpsyg.2019.02813. eCollection 2019.
- Background: PubMed 31124262Pecini C, Spoglianti S, Bonetti S, Di Lieto MC, Guaran F, Martinelli A, Gasperini F, Cristofani P, Casalini C, Mazzotti S, Salvadorini R, Bargagna S, Palladino P, Cismondo D, Verga A, Zorzi C, Brizzolara D, Vio C, Chilosi AM. Training RAN or reading? A telerehabilitation study on developmental dyslexia. Dyslexia. 2019 Aug;25(3):318-331. doi: 10.1002/dys.1619. Epub 2019 May 23.
- Background: PubMed 23020641Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Background: PubMed 28073076Di Lieto MC, Brovedani P, Pecini C, Chilosi AM, Belmonti V, Fabbro F, Urgesi C, Fiori S, Guzzetta A, Perazza S, Sicola E, Cioni G. Spastic diplegia in preterm-born children: Executive function impairment and neuroanatomical correlates. Res Dev Disabil. 2017 Feb;61:116-126. doi: 10.1016/j.ridd.2016.12.006. Epub 2017 Jan 7.
- Background: PubMed 15525564Pirila S, van der Meere J, Korhonen P, Ruusu-Niemi P, Kyntaja M, Nieminen P, Korpela R. A retrospective neurocognitive study in children with spastic diplegia. Dev Neuropsychol. 2004;26(3):679-90. doi: 10.1207/s15326942dn2603_2.
- Background: PubMed 11311028Schatz J, Craft S, White D, Park TS, Figiel GS. Inhibition of return in children with perinatal brain injury. J Int Neuropsychol Soc. 2001 Mar;7(3):275-84. doi: 10.1017/s1355617701733012.
- Background: PubMed 23809003Bodimeade HL, Whittingham K, Lloyd O, Boyd RN. Executive function in children and adolescents with unilateral cerebral palsy. Dev Med Child Neurol. 2013 Oct;55(10):926-33. doi: 10.1111/dmcn.12195. Epub 2013 Jun 28.
- Background: PubMed 21398561Pirila S, van der Meere JJ, Rantanen K, Jokiluoma M, Eriksson K. Executive functions in youth with spastic cerebral palsy. J Child Neurol. 2011 Jul;26(7):817-21. doi: 10.1177/0883073810392584. Epub 2011 Mar 11.
- Background: PubMed 30553174Critten V, Messer D, Sheehy K. Delays in the reading and spelling of children with cerebral palsy: Associations with phonological and visual processes. Res Dev Disabil. 2019 Feb;85:131-142. doi: 10.1016/j.ridd.2018.12.001. Epub 2018 Dec 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Chiara Di Lieto, PhD contact
Giuseppina Sgandurra, MD, PhD principal investigator
IRCCS Fondazione Stella Maris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities, Tele-rehabilitation of EF and specific cognitive processes underlying academic skills and Game-based tools for the rehabilitation of EF and motor planning in people with Executive Functions in Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppina Sgandurra, MD, PhD (3392472874, g.sgandurra@fsm.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in score of inhibition subtest at the NEPSY-II (time frame: 1-36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288971, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.