NCT03329326

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

October 25, 2017

Last Update Submit

July 4, 2019

Conditions

AmputationProsthesis User

Keywords

standardized testprosthesisupper limb amputationrehabilitation outcome

Outcome Measures

Primary Outcomes (2)

  • Southampton Hand Assessement Procedure

    standardized test for prosthetic function

    1 day

  • Disabilities of Arm Shoulder and Hand

    questionnaire for hand function

    1 day

Secondary Outcomes (2)

  • Assessment of the Capacity of Myoelectric Control

    1 day

  • Short Form 36

    1 day

Other Outcomes (6)

  • Time since amputation [years]

    1 day

  • Time since fitting [years]

    1 day

  • Living alone [yes/no]

    1 day

  • +3 more other outcomes

Interventions

Functional tests and self-reported questionnairesOTHER

In this observational study no intervention is initiated. Patients included are only assessed with the non-invasive tests described earlier.

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study includes upper-limb amputees who are fitted with an acitve prosthesis. it is intented to have a diverse sample concerning age, gender, time since amputation,...

You may qualify if:

  • 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

You may not qualify if:

  • major neurologic or untreated psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Medical University of Vienna

Vienna, 1090, Austria

Location

Helsiniki University Central Hospital

Helsinki, Helsiniki, 00014, Finland

Location

University Medical Center Goettingen

Goettigen, Lower Saxony, 37075, Germany

Location

BG Trauma Center Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, 67071, Germany

Location

Sykehuset Innlandet HF

Ottestad, 2312, Norway

Location

Lund University

Lund, Skåne County, 221 00, Sweden

Location

Örebro University

Örebro, Örebro County, 702 81, Sweden

Location

Related Links

Study Officials

  • Agnes BM Sturma, BSc. MSc.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc, MSc

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 1, 2017

Study Start

November 1, 2017

Primary Completion

February 15, 2019

Study Completion

April 1, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

DE(2)FI(1)NO(1)AU(1)SE(2)