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

January 30, 2024 updated by: Associazione Italiana Ematologia Oncologia Pediatrica

Rehabilitative Evaluation of Functional Abilities in Children/Adolescents Affected by Cancer: a Validation Study of the GMFM-88 Scale and of the Functional Abilities Assessment in Pediatric Oncology (FAAP-O) Scale

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.

Study Overview

Status

Completed

Conditions

Detailed Description

In recent decades, improvements in the treatment of pediatric cancer patients have resulted in increased survival rates. Consequentially, clinicians now pay more attention to the quality of life of these patients, both during and after treatment. Functional abilities have an important role in the quality of life and these skills can be compromised by the tumor itself or by anti-neoplastic treatments. A recent Cochrane review regarding rehabilitation and motor activity in this population has documented the effectiveness of exercise in children with cancer. Furthermore, to improve the rehabilitation care of pediatric cancer patients it is important to broaden the research by structuring multi-center trials, which allow the collection of longitudinal data. Objective, repeatable, specific, and sensitive rehabilitation assessment tools are needed, to define the functional status of the patient and to measure the motor outcomes. The psychometric properties of a measurement are closely linked to the specific population in which the measurement is used. Currently, there are two validated assessment tools for children/adolescents with cancer used to evaluate functional abilities: The Gross Motor Function Scale-Acute Lymphoblastic Leukemia (GMFM-ALL) and the Motor Performance in Pediatric Oncology (MOON). The ladder has the merit of being structured to evaluate the motor skills of children/adolescents affected by various forms of cancer but it also presents some limits. This test does not investigate functional abilities in a rehabilitation optic and it requires the use of specific materials that can reduce its usability in multicenter trials. The GMFM-ALL scale is a modified version of the Gross Motor Function Measure 88 (GMFM-88) Scale. This scale is specific only for children/adolescents with Lymphoblastic Leukemia and it mainly evaluates motor skills that require a high functional level (i.e. jumps, running), possessed neither by younger children nor by those who show major physical impairments or during specific phases of cancer treatment, such as palliative care.

The GMFM-88 scale is a rehabilitation assessment tool that was originally created to investigate functional abilities in children affected by cerebral palsy (CP) and has subsequently been validated for other populations of pediatric patients. It was also used to evaluate functional abilities in some studies conducted on pediatric cancer patients. Some aspects make this tool easily applicable in multicenter studies: it does not require any material to be administered nor a specific certified training to use it and, lastly, it comprises all principal motor skills including the basic ones (i.e. lying and rolling on the ground).

Study Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Ospedale Papa Giovanni XXIII, UOS Onco-ematologia Pediatrica
      • Bolzano, Italy, 39100
        • Ospedale Azienda Sanitaria dell'Alto Adige - Comprensorio di Bolzano Servizio di Riabilitazione Fisica
      • Brindisi, Italy, 72100
        • IRCCS E. Medea La Nostra Famiglia
      • Firenze, Italy, 50139
        • AOU Meyer - UP Riabilitazione
      • Genova, Italy, 16147
        • IRCCS Istituto Giannina Gaslini - U.O. Med Fisica e riabilitazione
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori - S.C. Cure palliative, Terapia del Dolore e Riabilitazione
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza - OIRM
      • Trieste, Italy, 34137
        • IRCCS Materno Infantile Burlo Garofolo - S.C. Oncoematologia
    • Lecco
      • Bosisio Parini, Lecco, Italy, 23842
        • IRCCS E. Medea La Nostra Famiglia
    • Treviso
      • Conegliano, Treviso, Italy, 31015
        • IRCCS E. Medea La Nostra Famiglia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 15 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Construct validity of the GMFM-88 in measuring functional abilities of children and adolescents affected by cancer.
Time Frame: up to 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Content validity of the GMFM-88 items in evaluating functional abilities of children and adolescents affected by cancer
Time Frame: up to 1 year
Content Validity Ratio (CVR). CVR values range from -1 to +1. A satisfactory CVR should be ≥ 0.70.
up to 1 year
Construct validity of the FAAP-O in assessing functional abilities of children and adolescents affected by cancer
Time Frame: up to 18 months
Cronbach's alpha A satisfactory index of a scale's homogeneity should have an alpha coefficient between 0.70 and 0.95.
up to 18 months
Inter-observer reliability and intra-observer reliability of the FAAP-O
Time Frame: through study competition, an average of 2 years
Interclass Correlation (ICC) ICC values range from 0 to 1. The repeatability of a test is considered high when ICC value is ≥ 0.8.
through study competition, an average of 2 years
Test-retest reliability of the FAAP-O
Time Frame: through study competition, an average of 2 years
Interclass Correlation (ICC) ICC values range from 0 to 1. The repeatability of a test is considered high when ICC value is ≥ 0.8
through study competition, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associazione Italiana Ematologia Oncologia Pediatrica

Investigators

  • Principal Investigator: Francesca Rossi, dr, A.O.U. Città della Salute e della Scienza - OIRM, Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2019

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

May 22, 2023

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAAP-O

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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