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临床试验/NCT03329326
NCT03329326已完成不适用

Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome

Medical University of Vienna7 个研究点 分布在 5 个国家目标入组 73 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
7
主要终点
Southampton Hand Assessement Procedure

研究概览

简要总结

Background and rational:

A large number of instruments exists to assess upper limb prosthetic function. However, they differ substantially in terms of psychometric properties and content. Furthermore, there is no "gold standard" and nearly every single center uses a unique set of instruments. This fact prevents the linking of the commonly small (due to the limited number of patients in each center) data sets of different centers and makes comparisons between different fittings or treatment protocols difficult. To generate accepted evidence, we need large data sets with similar outcomes. With remarkable progress made in prosthetic research and rehabilitation in the recent years, the need to evaluate the impact of this intervention on daily life, including productivity, self-care and leisure becomes increasingly relevant. Moreover, self-reported instruments and observation-based instruments exist, but there is a lack of data if, for example, the self-reported instrument (which is easier and less health-professional's-time-consuming to perform) could "replace" a performance or observation-based instrument.

Therefore, the aim of this study is to determine psychometric properties of the existing instruments (SHAP, DASH, SF-36 and ACMC) in a large international data set, to explore possible linkage between self-reported and performance or observation-based instruments and to develop state-of-the art recommendations/points to consider on how to assess functioning in prosthetic care.

详细描述

Background and rational:

A large number of instruments exists to assess upper limb prosthetic function. However, they differ substantially in terms of psychometric properties and content. Furthermore, there is no "gold standard" and nearly every single center uses a unique set of instruments. This fact prevents the linking of the commonly small (due to the limited number of patients in each center) data sets of different centers and makes comparisons between different fittings or treatment protocols difficult. To generate accepted evidence, we need large data sets with similar outcomes. With remarkable progress made in prosthetic research and rehabilitation in the recent years, the need to evaluate the impact of this intervention on daily life, including productivity, self-care and leisure becomes increasingly relevant. Moreover, self-reported instruments and observation-based instruments exist, but there is a lack of data if, for example, the self-reported instrument (which is easier and less health-professional's-time-consuming to perform) could "replace" a performance or observation-based instrument.

Therefore, the aim of this study is to determine psychometric properties of the existing instruments in a large international data set, to explore possible linkage between self-reported and performance or observation-based instruments and to develop state-of-the art recommendations/points to consider on how to assess functioning in prosthetic care. Projects exploring outcome assessments should have a broad basis and target different patient populations. To be able to generalize the outcome of the study for the European population, this study is planned as a multi-centre study. Also, having a sufficient number of subjects to calculate statistical relationships is otherwise not possible due the limited number of patients being treated at most centers.

Included patients:

  • age: 16-85 years
  • major uni-lateral amputation of the upper extremity (includes amputation of the hand, forearm, upper arm and at shoulder level)
  • normal hand function of the other side (in case of doubt: SHAP score ≥ 95)
  • no major neurologic or untreated psychological disorders
  • fitted with an active prosthesis (myo, body-powered or hybrid) for at least 6 months

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
16 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age: 16-85 years
  • major uni-lateral amputation of the upper extremity
  • normal hand function of the other side (in case of doubt: SHAP score ≥ 95)
  • fitted with an active prosthesis for at least 6 months
  • gives informed consent

排除标准

  • major neurologic or untreated psychological disorders

结局指标

主要结局

Southampton Hand Assessement Procedure

时间窗: 1 day

standardized test for prosthetic function

Disabilities of Arm Shoulder and Hand

时间窗: 1 day

questionnaire for hand function

次要结局

  • Short Form 36(1 day)
  • Assessment of the Capacity of Myoelectric Control(1 day)

研究者

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

Agnes Sturma

BSc, MSc

Medical University of Vienna

研究点 (7)

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