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临床试验/NCT06326229
NCT06326229招募中不适用

Clinical Validation of the Content of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services

University of Valladolid1 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2024年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
385
试验地点
1
主要终点
ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services)

研究概览

简要总结

The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services.

The main question it aims to answer is:

  • Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view?

Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition.

详细描述

Primary care physiotherapy services provide community-based care for musculoskeletal conditions. These conditions are often associated with disability and impact on patients' quality of life. The International Classification of Functioning, Disability and Health (ICF) is the global framework for describing disability. ICF Core Sets are ICF-based tools that facilitate the clinical use of this classification. Some ICF Core Sets are designed to describe the functioning of patients with musculoskeletal problems.

These Core Sets are focused on the acute phase, typical of emergency care, and the post-acute phase, intended for multidisciplinary teams in rehabilitation centers. However, no ICF core set exists for the final stages of these conditions, when the patient has been reintegrated into the community. The development of ICF Core Sets follows a scientific process that integrates the perspectives of researchers, patients, professionals, and the care setting. Therefore, preparatory studies were carried out, taking as a reference the physiotherapy services in primary care, where most of these conditions are treated. A preliminary ICF core set was developed from these studies, the entities of which were agreed upon through a subsequent cross-sectional study involving a group of primary care physiotherapy experts. In order to confirm the usefulness of this ICF core set, a cross-sectional study will be developed to assess the clinical relevance of the ICF entities included in it.

A multicenter cross-sectional observational study will be carried out in primary care physiotherapy services to assess the relevance of various aspects of functioning in patients with musculoskeletal problems. The participants will be people suffering from musculoskeletal problems referred to these services for treatment by a general practitioner. The ICF core set will be used as outcome measure and the relevance of its ICF entities will be assessed by the participants. For this purpose, a 100 mm visual analog scale will be used, where 0 will mean "no problem" and 100 will mean "complete problem". Scores will be converted into ICF qualifiers. The criterion for confirming each ICF entity will be that it represents a problem in at least 5% of the sample. Confirmation of the ICF entities will allow the development of an ICF-based clinical tool for the management of musculoskeletal conditions in primary care physiotherapy services.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Patients diagnosed with a musculoskeletal condition by a general practitioner
  • Patients with adequate knowledge of the Spanish language

排除标准

  • Patients referred for a non-musculoskeletal problem
  • Patients referred from hospital services

结局指标

主要结局

ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services)

时间窗: 2024-05/2024-12

The ICF entities to be used have been obtained in an observational study with registry number NCT06168721. The list of categories will be available in this registry once the study is published.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Héctor Hernández Lázaro

Principal Investigator

University of Valladolid

研究点 (1)

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