Comparison of Prosthetic Assessment Tools and Factors Influencing the Outcome

NCT03329326 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73

Last updated 2019-07-08

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329326 on ClinicalTrials.gov