Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees (MPK-AOPA)
December 11, 2018 updated by: Kenton R. Kaufman, Ph.D., Mayo Clinic
This study will assess if the functional performance and musculoskeletal outcome of transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a Non-Microprocessor Knees (NMPK).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study design is a reversal design whereby only the prosthetic knee joint will be changed.
Each subject will be tested using their current NMPK, fit and tested with a MPK, and then tested again with their NMPK.
MPK prostheses from all manufacturers will be considered appropriate for testing.
Each MPK to be used in this study is FDA approved.
The foot will be in the L5981 class, e.g.
flex foot or equivalent.
The same socket, suspension, and foot will be used throughout the study in order to eliminate these confounding variables.
All prosthesis fittings will be performed by the subject's own certified prosthetist according to manufacturers' fitting guidelines.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
51 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Unilateral transfemoral amputee
- Medicare Functional Classification Level K2 or K3
- Currently using NMPK prosthesis
- No current residual limb problems, such as skin breakdown
- Able to ambulate without a gait aid
Exclusion Criteria:
- Previous stroke or other neuromuscular complications currently affecting gait
- Currently undergoing dialysis treatments
- Amputation of the contralateral limb
- Poor fit of current NMPK prosthesis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prosthetic knee joints
Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g.
A-B-A design.
|
MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily Activity Measured With Triaxial Accelerometers
Time Frame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
|
Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days.
Primary outcome will be the difference in activity level between the NMPK and MPK measurements.
|
Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
|
|
Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)
Time Frame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
|
The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls.
The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements.
The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.
|
Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
Time Frame: Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
|
The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements. The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life. |
Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
September 8, 2014
First Submitted That Met QC Criteria
September 11, 2014
First Posted (Estimate)
September 15, 2014
Study Record Updates
Last Update Posted (Actual)
December 12, 2018
Last Update Submitted That Met QC Criteria
December 11, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 14-002930
- Foundation (Other Identifier: Ivy Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.