Clinical trial · Observational
Validation of the GMFM-88 Scale and of the FAAP-O Scale in Pediatric Patients Affected by Cancer
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
NCT04862130CI-TRIAL-00073454FAAP-OcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Construct validity of the GMFM-88 in measuring functional abilities of children and adolescents affected by cancer.
- timeFrame
- up to 1 year
- description
- Cronbach's alpha. A satisfactory index of a scale's homogeneity should have an alpha coefficient between 0.70 and 0.95.
Secondary outcomes (4)
- measure
- Content validity of the GMFM-88 items in evaluating functional abilities of children and adolescents affected by cancer
- timeFrame
- up to 1 year
- description
- Content Validity Ratio (CVR). CVR values range from -1 to +1. A satisfactory CVR should be ≥ 0.70.
- measure
- Construct validity of the FAAP-O in assessing functional abilities of children and adolescents affected by cancer
- timeFrame
- up to 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (12)
- BACKGROUNDDe 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
- BACKGROUNDBraam 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
- BACKGROUNDByer 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
- BACKGROUNDCorr 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
- BACKGROUNDGatta 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
- BACKGROUNDGemus 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.