跳至主要内容
临床试验/NCT04862130
NCT04862130已完成不适用

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

Associazione Italiana Ematologia Oncologia Pediatrica8 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2019年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
217
试验地点
8
主要终点
Construct validity of the GMFM-88 in measuring functional abilities of children and adolescents affected by cancer.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
6 Months 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Inter-observer reliability and intra-observer reliability of the FAAP-O(through study competition, an average of 2 years)
  • 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)
  • Test-retest reliability of the FAAP-O(through study competition, an average of 2 years)

研究者

发起方
Associazione Italiana Ematologia Oncologia Pediatrica
申办方类型
Other
责任方
Sponsor

研究点 (8)

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