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Effects of Microprocessor-controlled Knee Joints on Community Outcomes

NCT04112901 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2019-10-02

No results posted yet for this study

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 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.

Conditions

  • People With Trans-femoral Amputation

Interventions

DEVICE

Microprocessor-controlled knee joints

Any type of microprocessor-controlled knee joints will be considered; this includes those controlling stance phase only (e.g. Compact C-Leg), swing phase only (e.g. Smart IP), both swing and stance phases (e.g. Reho knee), or power generating knees (e.g. POWER knee Ossur).

DEVICE

Non-microprocessor-controlled knee joints

Any non-microprocessor-controlled knee joints such as prosthesis incorporating hydraulic, polycentric, pneumatic mechanisms, friction or locked knees.

Sponsors & Collaborators

  • University of Derby

    lead OTHER

Principal Investigators

  • Reza Safari · University of Derby

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2020-05-01
Completion
2020-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04112901 on ClinicalTrials.gov