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临床试验/NCT04112901
NCT04112901Unknown不适用

Activity, Mobility, Social Functioning, Mental Health and Quality of Life Outcomes in Limited Mobility Transfemoral and Knee Disarticulation Amputees Using Microprocessor-Controlled Knees or Non-Microprocessor Controlled Knees in the United Kingdom: A Cohort Study

University of Derby0 个研究点目标入组 330 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
330
主要终点
Short Form-36 Quality of Life (SF-36)

研究概览

简要总结

About 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). The increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult amputees indicates more amputees with limited mobility in the future. Among other factors, prosthesis success highly depends on the function of the knee joints during daily activities.

Presently, there are two categories of prosthetic knee joints; microprocessor-controlled knees (MPKs) and non-microprocessor-controlled knees (n-MPKs). Whilst the n-MPKs are unable to change the knee stiffness, the MPKs alter the joint stiffness and speed of movement according to the users' walking speed.

Although past studies indicate that MPKs could result in reduced risk of falls, improved balance and activity in limited mobility amputees, there is a lack of strong evidence on the effect of MPKs on community outcomes. The aim of this study is to compare activity, mobility, social functioning, depression, anxiety, and health-related quality of life in limited mobility trans-femoral or through-knee (i.e. knee disarticulation) amputees who are users of MPKs prosthesis with users of a prosthesis with n-MPKs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Unilateral transfemoral amputation or knee disarticulation
  • •≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground,
  • •Users of either MPK or N-MPK for at least 6 months prior to the recruitment date.

排除标准

  • •Not meeting inclusion criteria

结局指标

主要结局

Short Form-36 Quality of Life (SF-36)

时间窗: Baseline

The SF-36 is a validated generic measure of health-related quality of life consisting of eight scales (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions).

次要结局

  • Reintegration to Normal Living Index (RNLI)(Baseline)
  • Special Interest Group in Amputee Medicine (SIGAM)(Baseline)
  • Hospital Anxiety and Depression Scale (HADS)(Baseline)
  • Prosthetic Evaluation Questionnaire (PEQ); Mobility, Social Burden and Residual Limb Health Subscales.(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reza Safari

Research Fellow

University of Derby

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