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NCT04112901

Effects of Microprocessor-controlled Knee Joints on Community Outcomes

Status unknown Last updated 2 October 2019
What this trial tests

trial testing Microprocessor-controlled knee joints in People With Trans-femoral Amputation in 330 participants. Status unknown.

Timeline
15 January 2020
Primary endpoint
1 May 2020
30 May 2020

Quick facts

Lead sponsorUniversity of Derby
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment330
Start date15 January 2020
Primary completion1 May 2020
Estimated completion30 May 2020

Drugs / interventions tested

Conditions studied

Sponsor

University of Derby

Who can join

Adults 18 to 95, any sex, with People With Trans-femoral Amputation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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