Effects of Microprocessor-controlled Knee Joints on Community Outcomes

NCT04112901 | Unknown

• 1 other identifier: V1.2
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

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.

Conditions

People With Trans-femoral Amputation

Keywords

Trans-femoral amputation; Limb prosthesis; Microprocessor Controlled Knee Joints; Community Outcome Measures

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline

Secondary Outcomes (4)

• Special Interest Group in Amputee Medicine (SIGAM)

  Baseline

• Prosthetic Evaluation Questionnaire (PEQ); Mobility, Social Burden and Residual Limb Health Subscales.

  Baseline

• Reintegration to Normal Living Index (RNLI)

  Baseline

• Hospital Anxiety and Depression Scale (HADS)

  Baseline

Study Arms (1)

People with trans-femoral amputation or knee dis-articulation

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.

Device: Microprocessor-controlled knee joints; Device: Non-microprocessor-controlled knee joints

Interventions

Microprocessor-controlled knee joints DEVICE

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).

People with trans-femoral amputation or knee dis-articulation

Non-microprocessor-controlled knee joints DEVICE

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

People with trans-femoral amputation or knee dis-articulation

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Amputees registered with Amputee Rehabilitation Centres across the United Kingdom.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Derby: lead

Study Officials

• Reza Safari

  University of Derby

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Safari, PhD.

CONTACT

+441332592418; m.safari@derby.ac.uk

Nicola Barnett

CONTACT

01332 592035; n.barnett@derby.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: January 15, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 30, 2020
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share