NCT03329326

Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome

Medical University of Vienna·ClinicalTrials.gov·otherCompleted
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Functional tests and self-reported questionnaires
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
Medical University of Vienna
Location
Vienna,Helsinki,Goettigen,Ludwigshafen,Ottestad,Lund,Örebro, Austria,Finland,Germany,Norway,Sweden
Timeline & enrollment
Phase
N/A
Start date
Nov 01, 2017
End date
Apr 01, 2019
Enrollment
73 participants
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
Amputation of limb(s)Traumatic amputation of upper and lower limbs, any combination [any level]Traumatic amputations involving other combinations of body regionsTraumatic amputation of one hand and other arm [any level, except hand]Traumatic amputation of lower limb, level unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03329326
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03329326 through Pure Global AI's free database. This phase not specified trial is sponsored by Medical University of Vienna and is currently Completed. The study focuses on Amputation,Prosthesis User. Target enrollment is 73 participants.

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