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Cerebral PalsyiCARENCT06737471

Cp eArly REhabilitation

An observational study of Cerebral Palsy, run by IRCCS Eugenio Medea at 6 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The present study aims to investigate the efficacy of play-based rehabilitation delivered as usual care in children with cerebral palsy in a rehabilitation center offering both intensive and extensive care. Up to now, few studies described and examined treatments' efficacy in this population. Read more about this study

Who is it for?
Ages 36 months to 5 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Intensive rehabilitation treatment and Extensive rehabilitation treatment
How many people
96 participants
Where
6 sitesItaly
Study dates
21 May 2024to 31 Dec 2026
Phase
Observational
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 36 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children with cerebral palsy aged 6 months to 5 years receiving rehabilitation as usual care will be included in the study.

Who may be able to join

  • age between 6 months (corrected age in case of prematurity) and 5 years;
  • a diagnosis of cerebral palsy due to perinatal suffering, neurological syndromes, rare diseases with neurological impairment or congenital diseases of unknown nature.

Who cannot join

  • profound deafness and/or severe hypovisus/blindness;
  • a diagnosis of neurodegenerative diseases, acquired brain injury or brain tumor.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

Italy6 sites, 6 recruiting
  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno e Residenziale

    Bosisio Parini, Lecco, 23842

    Site Responsible, +39031877111, urp.bosisio@lanostrafamiglia.it

    Recruiting
  • Scientific IRCCS, E. Medea

    Bosisio Parini, Lecco, 23842

    Sandra Strazzer, MD, 0039877111, sandra.strazzer@lanostrafamiglia.it

    Sandra Strazzer, MD

    Recruiting
  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

    Carate Brianza, Monza E Brianza, 20841

    Site Responsible, +390362904035, carate.brianza@lanostrafamiglia.it

    Recruiting
  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno

    Como, Como, 22100

    Site Responsible, +39031525755, amb.como@lanostrafamiglia.it

    Recruiting
  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

    Sesto San Giovanni, Milano, 20099

    Site Responsible, +39022428594, sestosg@lanostrafamiglia.it

    Recruiting
  • Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno

    Vedano Olona, Varese, 21040

    Site Responsible, +390332866080, vedano.olona@lanostrafamiglia.it

    Recruiting

Other trials in Italy

About this study

Official title: Italian Cp eArly REhabilitation (iCARE)

The present study aims to investigate the efficacy of play-based rehabilitation delivered as usual care in children with cerebral palsy in a rehabilitation center offering both intensive and extensive care. Up to now, few studies described and examined treatments' efficacy in this population.

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.

Read the detailed description

Cerebral Palsy (CP) is the most common cause of disability in childhood and is characterized by permanent disorders of movement and posture development, causing important limitations in autonomy. CP is attributable to non-progressive disorders that occur in the fetal and infant brain during development. Motor disorders are often accompanied by epilepsy, secondary musculoskeletal problems and impairments in different areas, such as sensory and perceptual domains, intelligence, communication abilities and behavior regulation.

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
Cerebral Palsy
Being tested
Intensive rehabilitation treatment, Extensive rehabilitation treatment
Keywords
cerebral-palsy; children; pediatric; intervention; rehabilitation; motor; cognitive
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive rehabilitation treatmentOther

    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 treatmentOther

    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.

Study groups in NCT06737471
Study groupRoleWhat they receive
Extensive rehabilitation treatmentA 3-hour weekly rehabilitation treatment is delivered to each patient in an outpatient setting for 15 weeks.
Receives: Other: Extensive rehabilitation treatment
Intensive rehabilitation treatmentA 3-hour daily rehabilitation treatment is delivered to each patient in the care units of the Hospital for 5 weeks.
Receives: Other: Intensive rehabilitation treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Independence Measure for children (WeeFIM)

    The WeeFIM scale assesses the ability of a child in day-to-day functional tasks related to the 3 following main domains: self-care, mobility and cognition. It is composed of 18 items, each evaluating child's performance on a 7-point ordinal scale. WeeFIM is usually adopted in typically developing children aged 6 months-7 years. However, for children with developmental disabilities, the scale can be used up to 21 years.

    Measured: At baseline, immediately after the intervention and at an 8-month follow-up.

  2. The Gross Motor Function Measure 88 (GMFM-88)

    The Gross Motor Function Measure 88 (GMFM-88) allows measuring changes in gross motor function over time or with intervention in children with cerebral palsy. Items span the spectrum of gross motor activities in 5 dimensions 1) Lying and Rolling; 2) Sitting; 3) Crawling and Kneeling; 4) Standing; 5) Walking, Running and Jumping. Items evaluate performance on a 3-point Likert scale. Higher scores indicate better performance.

    Measured: At baseline, immediately after the intervention and at an 8-month follow-up.

Secondary outcomes (1)
  1. The Behavior Rating Inventory of Executive Function-Preschool Version -parent form

    The Behavior Rating Inventory of Executive Function-Preschool Version -parent form is a parent report assessing specific components of executive functions through observable everyday behaviors in children aged 2 to 5:11 years. It has 5 clinical scales (Inhibit, Shift, Emotional Control, Working Memory, Plan/Organize), 3 composite indices (Inhibitory Self-Control Index (ISCI), Flexibility Index (FI), Emergent Metacognition Index (EMI)), and an overall composite score known as the Global Executive Composite (GEC).

    Measured: At baseline, immediately after the intervention and at an 8-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2024
  2. Study start21 May 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06737471
Sponsor's protocol ID
1114
Acronym
iCARE
Status last verified
Apr 2025
First submitted
12 Dec 2024
Last updated
1 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23139425
  • 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.

    PubMed 23721091
  • 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.

    PubMed 7525140
  • 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.

    PubMed 33999106
  • 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.

    PubMed 31180136
  • 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.

    PubMed 21707596
  • 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.

    PubMed 28715518

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, run by IRCCS Eugenio Medea at 6 sites 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 Sandra Strazzer, MD (+39031877111, sandra.strazzer@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Independence Measure for children (WeeFIM) (time frame: At baseline, immediately after the intervention and at an 8-month follow-up.). The study lists 2 primary outcomes in all. 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 NCT06737471, which also lists 7 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 May 2025.

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