Assessment of community outcomes and impact of COVID-19 in users of microprocessorcontrolled or mechanical knee joints.

• Research type

  Research Study

• Full title

  Activity, Mobility, Social Functioning, Mental Health, Quality of Life and Impact of COVID-19 in Transfemoral and Knee Disarticulation Amputees Using Microprocessor-Controlled Knees or Non-Microprocessor Controlled Knees in the United Kingdom: A Cohort Study.

• IRAS ID

  270538

• Contact name

  Reza Safari

• Contact email

  m.safari@derby.ac.uk

• Sponsor organisation

  University of Derby

• Clinicaltrials.gov Identifier

  NCT04112901, clinicaltrials.gov

• Duration of Study in the UK

  0 years, 7 months, 27 days

• Research summary

  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 previous studies have indicated 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.

  Administrative staffs at Amputee Rehabilitation Centres across the UK will recruit n=330 limited mobility amputees who are users of a prosthesis with either MPKs or n-MPKs joints. Eligible amputees will receive study pack containing Participants Information Sheet and outcome questionnaires and will be asked to complete the questionnaires and return them to researchers.

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  19/WM/0343

• Date of REC Opinion

  19 Nov 2019

• REC opinion

  Favourable Opinion