Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome - Trial NCT03329326

Timeline & Enrollment

Primary Outcome

Southampton Hand Assessement Procedure,Disabilities of Arm Shoulder and Hand

Summary

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.

ICD-10 Classifications