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临床试验/NCT05860764
NCT05860764
招募中
不适用

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 个研究点 分布在 1 个国家目标入组 30 人2023年2月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Vascular Disease, Peripheral
发起方
University of Leicester
入组人数
30
试验地点
1
主要终点
qualitative theme identification
状态
招募中
最后更新
2年前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2023年2月1日
结束日期
2024年9月
最后更新
2年前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

qualitative theme identification

时间窗: baseline

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

研究点 (1)

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