NCT02240186|CompletedResults
Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees
MPK-AOPA
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MPK-AOPA
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · American Orthotic and Prosthetic Association
interventional
50
1 country
1
Study Start
June 2014
Actual (reported)Primary Completion
June 2017
Actual (reported)Study Completion
December 2017
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2014
Actual (reported)September 8, 2014
Actual (reported)September 15, 2014
Actual (reported)June 2017
Actual (reported)December 2017
Actual (reported)December 12, 2018
Actual (reported)Daily Activity Measured With Triaxial Accelerometers
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)
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)
Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)
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)
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.
Mayo Clinic
Rochester, Minnesota, 55905, United States
Kaufman KR, Bernhardt KA, Symms K. Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees. Clin Biomech (Bristol). 2018 Oct;58:116-122. doi: 10.1016/j.clinbiomech.2018.07.012. Epub 2018 Jul 19.
Kenton R Kaufman, PhD
Mayo Clinic
50 participants (actual enrollment reported by the registry).
First Submitted
September 8, 2014
First Posted
September 15, 2014
Study Start
June 2014
Actual (reported)Decoding Motion Planning Using Cortical Potentials
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2017
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
December 12, 2018
Results First Posted
December 12, 2018
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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