Effects of Microprocessor-controlled Knee Joints on Community Outcomes

• Conditions: People With Trans-femoral Amputation
• Interventions: Device: Microprocessor-controlled knee joints; Device: Non-microprocessor-controlled knee joints

• Registration Number: NCT04112901
• Lead Sponsor: University of Derby

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Last Update Submitted: 2019-09-30
• Study First Posted: 2019-10-02
• Last Update Posted: 2019-10-02
• Study Start: 2020-01-15
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• 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.

Exclusion Criteria

• Not meeting inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People with trans-femoral amputation or knee dis-articulation	Microprocessor-controlled knee joints	include individuals with unilateral transfemoral amputation or knee disarticulation, with ≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground, who have been users of either microprocessor-controlled knee or non-microprocessor-controlled knee joint for at least 6 months prior to the recruitment date.
People with trans-femoral amputation or knee dis-articulation	Non-microprocessor-controlled knee joints	include individuals with unilateral transfemoral amputation or knee disarticulation, with ≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground, who have been users of either microprocessor-controlled knee or non-microprocessor-controlled knee joint for at least 6 months prior to the recruitment date.

Primary Outcome Measures

Name	Time	Method
Short Form-36 Quality of Life (SF-36)	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).

Secondary Outcome Measures

Name	Time	Method
Reintegration to Normal Living Index (RNLI)	Baseline	RNLI measures the degree to which people with traumatic or incapacitating illness reintegrate into normal social activities (e.g. recreation, movement in the community, and interaction in the family or other relationships). Respondents rate 11 questions on Visual Analogue Scales.
Special Interest Group in Amputee Medicine (SIGAM)	Baseline	SIGAM describe a single-item scale comprising six clinical grades (A -F) of amputee mobility. SIGAM is a self-report questionnaire with 21 dichotomous (Y/N) items and algorithm designed to facilitate grade assignment.
Hospital Anxiety and Depression Scale (HADS)	Baseline	The HADS scale is used to measure the level of anxiety and depression a person experiencing. It comprises 14 items on the four-point Likert scale; Seven items on anxiety and seven items on depression.
Prosthetic Evaluation Questionnaire (PEQ); Mobility, Social Burden and Residual Limb Health Subscales.	Baseline	These scales contain 22 questions (Mobility and transfer, n=13; social burden, n=3, residual limb health, n=6) using the visual analog scales. The PEQ is a valid and reliable measure of the prosthetic related quality of life. It consisted of nine sub-scales, which are not dependent on each other.