Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
96 participants
OBSERVATIONAL
2024-05-21
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Secondary aim of the study will be comparing the efficacy of the two rehabilitation treatment formats (intensive vs. extensive), which will have the same dose (sessions delivered) and ingredients (content). The intervention delivered as extensive care (3 sessions per week per 15 weeks) will be offered in community rehabilitation centers (Centri di Riabilitazione-CDR), while the one delivered as intensive care (3 sessions daily per 5 days a week for 3 weeks) will be offered to children admitted to hospital inpatient care units. This comparison allows verifying if delivery time may affect outcomes.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
NCT03521427
A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy
NCT00473447
Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality
NCT04270305
Personalized Innovative Intervention Pathways to Promote EF in Children With CP
NCT06288971
Cross-Training and Locomotor Abilities in Cerebral Palsy
NCT06750081
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The criteria for early diagnosis of CP have been refined over time and now it may be possible to obtain a diagnosis also when the child is less than 5 months of age, when movement alterations can be detected by clinicians and neuroradiological data may confirm the diagnosis, allowing early and ad hoc patients' management in an important period for brain plasticity. In the Italian context, delays in access and limitations in the continuity of care process have been found. After diagnosis, it is fundamental to use specific tools designed to assess and classify the severity of the CP. In the motor domain, the Gross Motor Function Classification System (GMFCS) and the Manual Ability Classification System (MACS) are used to examine for manipulative skill activities. Communication skills can be assessed by using the Communication Function Classification System, visual abilities by using the Visual Function Classification System (VFCS) and aspiration risk by using the Eating and Drinking Ability Classification System (EDACS). Cognitive aspects should be assessed by adopting the age-related Wechsler scales. When it is not possible to administer these scales, that is to children aged less than 2.5 years or to those presenting with aphasia, blindness, or severe cognitive difficulties, different tools should be used, such as the Griffiths Mental Development Scales (GMDS), measuring and assessing the developmental rates of children from birth to age 6. The combination of data based on these tools allows having an overall picture of the of child's functioning.
Early interventions are based on the following principles: (1) facilitating the child's active movements rather than focusing only on stretching or passive movements; (2) setting up an enriched play environment to increase stimulation and motivation; (3) improving developmental skills to favor developmental progress. Rehabilitation interventions delivered in accordance with these three principles should be guided by a pathology-specific assessment and aimed at addressing specific objectives and clearly measuring the results. Follow-up monitoring of the child is essential to assess the effectiveness of interventions and update treatment plans, by adapting interventions to the progressive needs of each child, which could optimize treatment outcomes. By adhering to evidence-based practices following the latest scientific evidence, healthcare professionals may enhance the quality of the care and, as a consequence, the likelihood of positive better quality of life for children. Nevertheless, up to now, few studies described and examined treatments' efficacy in this population focusing on the best format to adopt; also, no clear indications on whether a different setting (intensive vs extensive) for intervention delivery may lead to different outcomes are available.
With respect to the motor domain, it has been highlighted the importance to deliver interventions that favor the autonomous exploration of the environment by the child and include strategies to sustain purposeful movements. The evidence, although limited, seems to suggest that "movement tasks" that support the motivation of the child to try to complete an activity and to reach a goal, even through trial and error, should be used. In order to plan an intervention personalized for each child, it is essential to take into account the topographical characteristics of the motor impairment. Specific rehabilitation proposals for upper limb rehabilitation in the hemiplegic child have already been reported.
In line with the principles of a family-centered-care approach, clinicians should involve parents and caregivers in the care process, so that they may have an active role in the child's rehabilitation practice outside the clinic. In fact, parents may play a fundamental role in setting the goals of the therapy practice in the ecological setting and may choose tasks at an appropriate level of difficulty for their child. Further, they may to expose the child to enjoyable motor activities performed in an enriched environment with adequate frequency and intensity, so that new motor skills can be developed and learned. Rehabilitation approaches such as the 'Goals-Activity-Motor Enrichment' (GAME), based on the combination of motor training, interaction with the environment, environmental enrichment, and parental coaching, and the 'Small Step Program' \[19\], based on the promotion of gross-motor and postural skills, the use of hands for environmental exploration and communication, are clear examples of the implementation of the principles outlined above.
However, the literature on early interventions for high-risk infants is still at an embryonic phase: studies are heterogeneous, provide weak evidence on outcomes and their methodological quality is limited. Generally, for all neurological disabilities guidance on how to develop and deliver appropriate, targeted, and evidence-based rehabilitation interventions is limited. Therefore, it is necessary to conduct further research on the topic.
In many cases, the evidence of treatment response has not been robust enough to demonstrate a change in trained functions that is clinically, statistically, and economically important. In this regard, Rob Forsyth and colleagues have suggested that the exclusive focus on therapy dose could be misleading, as rehabilitation content should also be precisely captured.
In our Institute (Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy) rehabilitation interventions are delivered both in community rehabilitation centers (Centri di Riabilitazione-CDR), where activities are offered as extensive care, and in the inpatient care units of the Hospital, where shorter but more intensive rehabilitation interventions are offered. For both treatment delivery options, decades of experience have been collected. In this study, we aim at assessing the global efficacy of rehabilitation interventions offered as usual care, together with comparing the efficacy of intensive and extensive treatment formats . This is to evaluate if time and intensity in rehabilitation delivery can be considered a mediator variable affecting outcomes. Both interventions have the same treatment dose (sessions delivered) and ingredients (content).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Extensive rehabilitation treatment
A 3-hour weekly rehabilitation treatment is delivered to each patient in an outpatient setting for 15 weeks.
Extensive rehabilitation treatment
A 3-hour weekly rehabilitation treatment will be delivered to each patient for 15 weeks (45 hours) in an outpatient setting.
Rehabilitation will address the following macro goals: gross motor, manipulative, visual and visual-cognitive.
Intensive rehabilitation treatment
A 3-hour daily rehabilitation treatment is delivered to each patient in the care units of the Hospital for 5 weeks.
Intensive rehabilitation treatment
A 3-hour daily rehabilitation treatment will be delivered to each patient 5 days a week for 5 weeks (45 hours) in the care units of the Hospital.
Rehabilitation will address the following macro goals: gross motor, manipulative, visual and visual-cognitive.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intensive rehabilitation treatment
A 3-hour daily rehabilitation treatment will be delivered to each patient 5 days a week for 5 weeks (45 hours) in the care units of the Hospital.
Rehabilitation will address the following macro goals: gross motor, manipulative, visual and visual-cognitive.
Extensive rehabilitation treatment
A 3-hour weekly rehabilitation treatment will be delivered to each patient for 15 weeks (45 hours) in an outpatient setting.
Rehabilitation will address the following macro goals: gross motor, manipulative, visual and visual-cognitive.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* a diagnosis of cerebral palsy due to perinatal suffering, neurological syndromes, rare diseases with neurological impairment or congenital diseases of unknown nature.
Exclusion Criteria
* a diagnosis of neurodegenerative diseases, acquired brain injury or brain tumor.
36 Months
5 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Eugenio Medea
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno
Como, Como, Italy
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno e Residenziale
Bosisio Parini, Lecco, Italy
Scientific IRCCS, E. Medea
Bosisio Parini, Lecco, Italy
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale
Sesto San Giovanni, Milano, Italy
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale
Carate Brianza, Monza E Brianza, Italy
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno
Vedano Olona, Varese, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Ko J, Kim M. Reliability and responsiveness of the gross motor function measure-88 in children with cerebral palsy. Phys Ther. 2013 Mar;93(3):393-400. doi: 10.2522/ptj.20110374. Epub 2012 Nov 8.
Duku E, Vaillancourt T. Validation of the BRIEF-P in a sample of Canadian preschool children. Child Neuropsychol. 2014;20(3):358-71. doi: 10.1080/09297049.2013.796919. Epub 2013 May 31.
Msall ME, DiGaudio K, Rogers BT, LaForest S, Catanzaro NL, Campbell J, Wilczenski F, Duffy LC. The Functional Independence Measure for Children (WeeFIM). Conceptual basis and pilot use in children with developmental disabilities. Clin Pediatr (Phila). 1994 Jul;33(7):421-30. doi: 10.1177/000992289403300708.
Morgan C, Fetters L, Adde L, Badawi N, Bancale A, Boyd RN, Chorna O, Cioni G, Damiano DL, Darrah J, de Vries LS, Dusing S, Einspieler C, Eliasson AC, Ferriero D, Fehlings D, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Mak C, Maitre N, McIntyre S, Mei C, Morgan A, Kakooza-Mwesige A, Romeo DM, Sanchez K, Spittle A, Shepherd R, Thornton M, Valentine J, Ward R, Whittingham K, Zamany A, Novak I. Early Intervention for Children Aged 0 to 2 Years With or at High Risk of Cerebral Palsy: International Clinical Practice Guideline Based on Systematic Reviews. JAMA Pediatr. 2021 Aug 1;175(8):846-858. doi: 10.1001/jamapediatrics.2021.0878.
Baranello G, Signorini S, Tinelli F, Guzzetta A, Pagliano E, Rossi A, Foscan M, Tramacere I, Romeo DMM, Ricci D; VFCS Study Group. Visual Function Classification System for children with cerebral palsy: development and validation. Dev Med Child Neurol. 2020 Jan;62(1):104-110. doi: 10.1111/dmcn.14270. Epub 2019 Jun 10.
Hidecker MJ, Paneth N, Rosenbaum PL, Kent RD, Lillie J, Eulenberg JB, Chester K Jr, Johnson B, Michalsen L, Evatt M, Taylor K. Developing and validating the Communication Function Classification System for individuals with cerebral palsy. Dev Med Child Neurol. 2011 Aug;53(8):704-10. doi: 10.1111/j.1469-8749.2011.03996.x. Epub 2011 Jun 27.
Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1114
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.