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Clinical Trials/NCT05860764
NCT05860764
Recruiting
Not Applicable

Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study: Exploratory Study Investigating Perceptions and Experience of Physical Performance and Physical Assessment of Vascular Amputees Using Performance Based Outcome Measures

University of Leicester1 site in 1 country30 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Disease, Peripheral
Sponsor
University of Leicester
Enrollment
30
Locations
1
Primary Endpoint
qualitative theme identification
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Background:

Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years.

After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. This is due to them experiencing: older age, muscle weakness, pain, other health conditions limiting ability to exercise eg. heart problems.

Healthcare professionals assess physical function with Physical Performance Based Outcome Measures (PerBOMs). A PerBOM requires an individual to complete tasks that are part of their day to day life e.g. walking or balance.

PerBOMs are used with for:

  • Setting goals with patients
  • Assessing how patients respond to treatment/rehabilitation
  • Predicting if patients are likely to use a prosthetic limb in the future

Previous research shows most of the available PerBOMs are suitable an amputee who walks with a prosthetic limb. However, most vascular amputee patients cannot benefit from these assessments.

Therefore, based on this evidence we have developed a new PerBOM to help manage vascular amputees who do not walk with a prosthetic limb.

Methods:

Qualitative interviews and focus groups with amputee individuals and healthcare professionals who treat them. Approaching individuals who have or will undergo an amputation to their leg due to PAD. Approaching healthcare professionals through professional networks.

Interviews and focus groups will take place face to face or remotely by telephone/video conferencing, lasting approximately 1-2 hrs.

In the interview or focus group, the researcher will explain and show individuals a video of the new PerBOM and explore their opinions qualitatively on this new PerBOM.

All audio will be recorded, written up and analysed. All findings will be presented at scientific conferences.

This study has been developed with patients and public involvement.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
September 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

qualitative theme identification

Time Frame: baseline

qualitative themes will be identified after data collection through qualitative interviews and focus groups and thematic analysis has taken place

Study Sites (1)

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