Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study

University of Leicester

Status

Enrolling

Conditions

Physical Disability

Amputation

Vascular Disease, Peripheral

Study type

Observational

Funder types

Other

Identifiers

NCT05860764

0873

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Vascular amputee group:

Inclusion criteria

Undergone major lower limb amputation due to peripheral arterial disease and/or diabetes at any time point
or
Planned date for major lower limb amputation within 1 week of consent due to peripheral arterial disease and/or diabetes

Exclusion criteria

Has/will undergo a minor amputation only
Amputation due to alternative aetiology
No plan for amputation to lower limb
Unable to communicate or write in English
Lacking capacity to consent to research study
>1 weeks or unspecified date for amputation surgery
<18 years

Healthcare professional group:

Inclusion criteria

• Healthcare professional currently working with vascular amputees. Healthcare professional defined as qualified professional background e.g. HCPC, NMC or GMC registered or non-qualified professional background e.g. healthcare support worker

Exclusion criteria