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Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05860764
Acronym
VAmPP-Q
Enrollment
30
Registered
2023-05-16
Start date
2023-02-01
Completion date
2024-09-30
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Physical Disability, Vascular Disease, Peripheral

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.

Interventions

None listed

Sponsors

University of Leicester
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

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

Countries

United Kingdom

Contacts

Primary ContactMiss Essop-Adam
aea19@leicester.ac.uk+44 (0)116 258 3473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026