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| ID | Type | Description | Link |
|---|---|---|---|
| Foundation | Other Grant/Funding Number | American Orthotic and Prosthetic Association |
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| Name | Class |
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| American Orthotic and Prosthetic Association | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic knee joints | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microprocessor Knee (MPK) | Device | MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenton R Kaufman, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30077128 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness. Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness. Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Activity measurement data were available for analysis on 46 baseline participants, 31 MPK participants, and 18 NMPK participants. | Posted | Mean | Standard Deviation | % of Day | 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) |
|
Acclimation period through assessment after reversion to the NMPK, up 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Microprocessor Knee (MPK): MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness. Non-Microprocessor Knee (NMPK): A NMPK is a mechanical knee with either hydraulic or pneumatic controls. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenton Kaufman, Principal Investigator | Mayo Clinic | 507-284-2262 | kaufman.kenton@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2014 | Sep 18, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Non-Microprocessor Knee (NMPK) | Device | A NMPK is a mechanical knee with either hydraulic or pneumatic controls. |
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| 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) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Data for falls were available for analysis on 46 baseline participants, 30 MPK participants, and 17 NMPK participants. | Posted | Median | Inter-Quartile Range | Falls per month | 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) |
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| Secondary | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | 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. | Not all participants completed all the scales in the questionnaire. | Posted | Mean | Standard Deviation | Score on a scale | 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) |
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| 0 |
| 50 |
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| 50 |
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| NMPK |
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| Appearance |
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| Frustration |
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| Perceived Response |
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| Residual Limb Health |
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| Social Burden |
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| Sounds |
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| Utility |
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| Well Being |
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