Cp eArly REhabilitation

NCT06737471 | Recruiting DMC

• 1 other identifier: 1114
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Cerebral Palsy

Keywords

cerebral-palsy; children; pediatric; intervention; rehabilitation; motor; cognitive

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (1)

• The Behavior Rating Inventory of Executive Function-Preschool Version -parent form

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

Study Arms (2)

Extensive rehabilitation treatment

A 3-hour weekly rehabilitation treatment is delivered to each patient in an outpatient setting for 15 weeks.

Other: Extensive rehabilitation treatment

Intensive rehabilitation treatment

A 3-hour daily rehabilitation treatment is delivered to each patient in the care units of the Hospital for 5 weeks.

Other: Intensive rehabilitation treatment

Interventions

Intensive rehabilitation treatment OTHER

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.

Intensive rehabilitation treatment

Extensive rehabilitation treatment OTHER

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.

Extensive rehabilitation treatment

Eligibility Criteria

• Age: 36 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (6)

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

Como, Como, 22100, Italy

RECRUITING

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale Diurno e Residenziale

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

Scientific IRCCS, E. Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

Sesto San Giovanni, Milano, 20099, Italy

RECRUITING

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

Carate Brianza, Monza E Brianza, 20841, Italy

RECRUITING

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

Vedano Olona, Varese, 21040, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 23139425 BACKGROUND

• 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.

  PMID: 23721091 BACKGROUND

• 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.

  PMID: 7525140 BACKGROUND

• 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.

  PMID: 33999106 BACKGROUND

• 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.

  PMID: 31180136 BACKGROUND

• 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.

  PMID: 21707596 BACKGROUND

• 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.

  PMID: 28715518 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Sandra Strazzer, MD

CONTACT

+39031877111; sandra.strazzer@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: May 21, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

IT (6)