Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome
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
- 否
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
Agnes Sturma
BSc, MSc
Medical University of Vienna
