Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome
NCT03329326 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73
Last updated 2019-07-08
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.
Conditions
- Amputation
- Prosthesis User
Interventions
- OTHER
-
Functional tests and self-reported questionnaires
In this observational study no intervention is initiated. Patients included are only assessed with the non-invasive tests described earlier.
Sponsors & Collaborators
-
University Medical Center Goettingen
collaborator OTHER -
Lund University
collaborator OTHER -
Örebro University, Sweden
collaborator OTHER -
Helsinki University Central Hospital
collaborator OTHER -
BG Trauma Center Ludwigshafen
collaborator OTHER -
Sykehuset Innlandet HF
collaborator OTHER -
Medical University of Vienna
lead OTHER
Principal Investigators
-
Agnes BM Sturma, BSc. MSc. · Medical University of Vienna
Eligibility
- Min Age
- 16 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-01
- Primary Completion
- 2019-02-15
- Completion
- 2019-04-01
Countries
- Austria
- Finland
- Germany
- Norway
- Sweden
Study Locations
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