Validation of the GMFM-88 Scale and of the FAAP-O Scale in Pediatric Patients Affected by Cancer

NCT04862130 | Completed

• 1 other identifier: FAAP-O
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective of this study is to validate the Gross Motor Function Measure Scale-88 (GMFM-88) on the Italian pediatric cancer population. The secondary objective is to implement the use of the GMFM-88 in clinical practice by validating a reduced panel of items that will be called the Functional Ability Assessment in Pediatric Oncology (FAAP-O) Scale.

Conditions

Oncology

Keywords

Physiotherapy; Rehabilitation; Functional abilities evaluation; motor function evaluation

Outcome Measures

Primary Outcomes (1)

• Construct validity of the GMFM-88 in measuring functional abilities of children and adolescents affected by cancer.

  Cronbach's alpha. A satisfactory index of a scale's homogeneity should have an alpha coefficient between 0.70 and 0.95.

  up to 1 year

Secondary Outcomes (4)

• Content validity of the GMFM-88 items in evaluating functional abilities of children and adolescents affected by cancer

  up to 1 year

• Construct validity of the FAAP-O in assessing functional abilities of children and adolescents affected by cancer

  up to 18 months

• Inter-observer reliability and intra-observer reliability of the FAAP-O

  through study competition, an average of 2 years

• Test-retest reliability of the FAAP-O

  through study competition, an average of 2 years

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents affected by cancer referred to the rehabilitation services of the participants centres.

You may qualify if:

• age between 6 months - 17 years and 11 months
• diagnosis of oncological disease
• being during antineoplastic treatment or up to 1 year off-therapy
• Written informed consent from patient or parents/legal representative, and age-appropriate assent.

You may not qualify if:

• Patients that are not able and willing to comply with study visits and procedures.

Sponsors & Collaborators

• Associazione Italiana Ematologia Oncologia Pediatrica: lead

Study Sites (10)

IRCCS E. Medea La Nostra Famiglia

Bosisio Parini, Lecco, 23842, Italy

Location

IRCCS E. Medea La Nostra Famiglia

Conegliano, Treviso, 31015, Italy

Location

Ospedale Papa Giovanni XXIII, UOS Onco-ematologia Pediatrica

Bergamo, 24127, Italy

Location

Ospedale Azienda Sanitaria dell'Alto Adige - Comprensorio di Bolzano Servizio di Riabilitazione Fisica

Bolzano, 39100, Italy

Location

IRCCS E. Medea La Nostra Famiglia

Brindisi, 72100, Italy

Location

AOU Meyer - UP Riabilitazione

Florence, 50139, Italy

Location

IRCCS Istituto Giannina Gaslini - U.O. Med Fisica e riabilitazione

Genova, 16147, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori - S.C. Cure palliative, Terapia del Dolore e Riabilitazione

Milan, 20133, Italy

Location

A.O.U. Città della Salute e della Scienza - OIRM

Torino, 10126, Italy

Location

IRCCS Materno Infantile Burlo Garofolo - S.C. Oncoematologia

Trieste, 34137, Italy

Location

Related Publications (12)

• De Angelis R, Sant M, Coleman MP, Francisci S, Baili P, Pierannunzio D, Trama A, Visser O, Brenner H, Ardanaz E, Bielska-Lasota M, Engholm G, Nennecke A, Siesling S, Berrino F, Capocaccia R; EUROCARE-5 Working Group. Cancer survival in Europe 1999-2007 by country and age: results of EUROCARE--5-a population-based study. Lancet Oncol. 2014 Jan;15(1):23-34. doi: 10.1016/S1470-2045(13)70546-1. Epub 2013 Dec 5.

  PMID: 24314615 BACKGROUND

• Braam KI, van der Torre P, Takken T, Veening MA, van Dulmen-den Broeder E, Kaspers GJ. Physical exercise training interventions for children and young adults during and after treatment for childhood cancer. Cochrane Database Syst Rev. 2016 Mar 31;3(3):CD008796. doi: 10.1002/14651858.CD008796.pub3.

  PMID: 27030386 BACKGROUND

• Byer L, Kline C, Mueller S. Clinical trials in pediatric neuro-oncology: what is missing and how we can improve. CNS Oncol. 2016 Oct;5(4):233-9. doi: 10.2217/cns-2016-0016. Epub 2016 Sep 12.

  PMID: 27616346 BACKGROUND

• Corr AM, Liu W, Bishop M, Pappo A, Srivastava DK, Neel M, Rao B, Wilson T, Ness KK. Feasibility and functional outcomes of children and adolescents undergoing preoperative chemotherapy prior to a limb-sparing procedure or amputation. Rehabil Oncol. 2017 Jan;35(1):38-45.

  PMID: 28948112 BACKGROUND

• Gatta G, Botta L, Rossi S, Aareleid T, Bielska-Lasota M, Clavel J, Dimitrova N, Jakab Z, Kaatsch P, Lacour B, Mallone S, Marcos-Gragera R, Minicozzi P, Sanchez-Perez MJ, Sant M, Santaquilani M, Stiller C, Tavilla A, Trama A, Visser O, Peris-Bonet R; EUROCARE Working Group. Childhood cancer survival in Europe 1999-2007: results of EUROCARE-5--a population-based study. Lancet Oncol. 2014 Jan;15(1):35-47. doi: 10.1016/S1470-2045(13)70548-5. Epub 2013 Dec 5.

  PMID: 24314616 BACKGROUND

• Gemus M, Palisano R, Russell D, Rosenbaum P, Walter SD, Galuppi B, Lane M. Using the gross motor function measure to evaluate motor development in children with Down syndrome. Phys Occup Ther Pediatr. 2001;21(2-3):69-79.

  PMID: 12029855 BACKGROUND

• Gohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16.

  PMID: 21370414 BACKGROUND

• Gotte M, Kesting S, Albrecht C, Worth A, Bos K, Boos J. MOON-test - determination of motor performance in the pediatric oncology. Klin Padiatr. 2013 May;225(3):133-7. doi: 10.1055/s-0033-1343411. Epub 2013 Apr 18.

  PMID: 23599231 BACKGROUND

• Lucia A, Ramirez M, San Juan AF, Fleck SJ, Garcia-Castro J, Madero L. Intrahospital supervised exercise training: a complementary tool in the therapeutic armamentarium against childhood leukemia. Leukemia. 2005 Aug;19(8):1334-7. doi: 10.1038/sj.leu.2403799. No abstract available.

  PMID: 15931268 BACKGROUND

• Ruck-Gibis J, Plotkin H, Hanley J, Wood-Dauphinee S. Reliability of the gross motor function measure for children with osteogenesis imperfecta. Pediatr Phys Ther. 2001 Spring;13(1):10-7.

  PMID: 17053645 BACKGROUND

• Wright MJ, Halton JM, Martin RF, Barr RD. Long-term gross motor performance following treatment for acute lymphoblastic leukemia. Med Pediatr Oncol. 1998 Aug;31(2):86-90. doi: 10.1002/(sici)1096-911x(199808)31:23.0.co;2-v.

  PMID: 9680932 BACKGROUND

• Rossi F, Valle M, Carlucci G, Tofani M, Galeoto G, Berchialla P, Sciannameo V, Clari M, Cardano M, Nota F, Bertin D, Calcagno A, Casalaz R, Cerboneschi M, Cervo M, Cornelli A, Fave MD, Esposito M, Ferrarese M, Imazio P, Lorenzon M, Longo L, Naretto G, Orsini N, Panzeri D, Pellegrini C, Peranzoni M, Picone F, Rabusin M, Trabacca A, Zigrino C, Martinuzzi A, Fagioli F, Ricci F. Development of Functional Abilities Assessment in Paediatric Oncology (FAAP-O) Scale for Children and Adolescents Affected by Cancer. Children (Basel). 2025 Sep 1;12(9):1163. doi: 10.3390/children12091163.

  PMID: 41007028 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Francesca Rossi, dr

  A.O.U. Città della Salute e della Scienza - OIRM, Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 27, 2021
• Study Start: November 14, 2019
• Primary Completion: October 30, 2020
• Study Completion: May 22, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

IT (10)