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Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study

NCT05860764 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-05-16

No results posted yet for this study

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.

Conditions

  • Vascular Disease, Peripheral
  • Amputation
  • Physical Disability

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • United Kingdom

Study Locations

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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 NCT05860764 on ClinicalTrials.gov