跳至主要内容
临床试验/NCT02508025
NCT02508025Unknown不适用

Towards Better Understanding of FCE Performance in Different Societal Contexts

Klinik Valens0 个研究点目标入组 100 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Psychological factor: work related fear of movement (minimum 0 - maximum 10)

研究概览

简要总结

Purposes of this research:

  • To study similarities and differences in FCE performances between participants from different countries, jurisdictions, and evaluators.
  • To study determinants of FCE performance.

详细描述

A considerable amount of research has been made on the safety, reliability and validity of the Functional Capacity Evaluation (FCE). Evidence is accumulating on different aspects of validity of FCE in healthy workers and in different patient groups, which has indicated that we are measuring a complex construct consisting of biological, psychological and social variables. However, this knowledge is still unstable as the majority of studies stem from a limited amount of countries. The present project focuses on the biopsychosocial factors that influence FCE performance. Participants undergoing an FCE perform differently depending on biological, psychological and social variables, although the latter has been under-researched. Clinicians are currently unable to predict which factors determine the differences in patient's FCE results. In this project, in addition to biological and psychological variables, investigators include a variety of social variables from different countries, jurisdictions, and evaluators, which may help investigators to identify important determinants of FCE performance. Knowing which characteristics and behaviors are associated with better or poorer participant performances may help clinicians to deliver improved FCE services.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Musculoskeletal pain including: back pain, neck pain (including Whiplash-Associated Syndrome grade I or II), upper extremity pain, lower extremity pain.
  • Non-specific pain: without specific medical diagnosis, see also exclusion criteria) .
  • Complaints' duration > 6 weeks
  • Employed or self-employed
  • Language skills sufficient to communicate with the FCE-clinician and fill out the required questionnaires

排除标准

  • Pregnancy
  • Fractures
  • Radicular syndromes
  • Spondylolisthesis grade 3 or 4)
  • Whiplash-Associated Syndrome grade III or IV
  • Other specific diagnoses related to the musculoskeletal System
  • Unstable cardiovascular conditions and other co-morbidity affecting performance or safety during the FCE (i.e. severe depression needing psychiatric referral).

结局指标

主要结局

Psychological factor: work related fear of movement (minimum 0 - maximum 10)

时间窗: one day (one measurement only, cross sectional study)

The fear avoidance beliefs questionnaire has been validated for this purpose

Financial compensation in case of work related disability (% of previous income)

时间窗: one day (one measurement only, cross sectional study)

次要结局

  • Work related physical capacity: grip strength (kg)(one day (one measurement only, cross sectional study))
  • Work related physical capacity: distance walked in 6 minutes (meters)(one day (one measurement only, cross sectional study))
  • Work related physical capacity: max weight safely lifted from floor to waist (kg)(one day (one measurement only, cross sectional study))

研究者

发起方
Klinik Valens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Kool

PhD

Klinik Valens

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