Lower Limb Amputation Above Knee (Injury)
Conditions
Keywords
Microprocessor-controlled knee, prosthesis, amputation
Brief summary
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).
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.
Interventions
DEVICEMicroprocessor Knee (MPK)
MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
DEVICENon-Microprocessor Knee (NMPK)
A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
Sponsors
American Orthotic and Prosthetic Association
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Activity Measured With Triaxial Accelerometers | 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. |
| Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Prosthetic Knee Joints | — |
|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 50 participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
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)
Population: Activity measurement data were available for analysis on 46 baseline participants, 31 MPK participants, and 18 NMPK participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthetic Knee Joints | Daily Activity Measured With Triaxial Accelerometers | Baseline | 15.64 % of Day | Standard Deviation 8362 |
| Prosthetic Knee Joints | Daily Activity Measured With Triaxial Accelerometers | MPK | 19.68 % of Day | Standard Deviation 11.88 |
| Prosthetic Knee Joints | Daily Activity Measured With Triaxial Accelerometers | NMPK | 18.23 % of Day | Standard Deviation 10.54 |
p-value: 0.01ANOVA
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.
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)
Population: Data for falls were available for analysis on 46 baseline participants, 30 MPK participants, and 17 NMPK participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Prosthetic Knee Joints | Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A) | Baseline | 2.0 Falls per month |
| Prosthetic Knee Joints | Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A) | MPK | 0.0 Falls per month |
| Prosthetic Knee Joints | Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A) | NMPK | 3.0 Falls per month |
p-value: 0.01ANOVA
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.
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)
Population: Not all participants completed all the scales in the questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Perceived Response | 85.23 Score on a scale | Standard Deviation 12.29 |
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Well Being | 53.47 Score on a scale | Standard Deviation 21.81 |
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Social Burden | 62.21 Score on a scale | Standard Deviation 22.75 |
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Residual Limb Health | 74.46 Score on a scale | Standard Deviation 19.95 |
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Ambulation | 39.07 Score on a scale | Standard Deviation 17.14 |
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Utility | 53.96 Score on a scale | Standard Deviation 16.48 |
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Frustration | 51.48 Score on a scale | Standard Deviation 29.44 |
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Appearance | 64.55 Score on a scale | Standard Deviation 18.81 |
| Prosthetic Knee Joints | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Sounds | 76.96 Score on a scale | Standard Deviation 25.28 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Residual Limb Health | 77.08 Score on a scale | Standard Deviation 15.58 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Ambulation | 49.58 Score on a scale | Standard Deviation 24.61 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Appearance | 74.43 Score on a scale | Standard Deviation 20.64 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Frustration | 66.28 Score on a scale | Standard Deviation 28.67 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Perceived Response | 89.28 Score on a scale | Standard Deviation 12.88 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Social Burden | 71.71 Score on a scale | Standard Deviation 23 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Sounds | 81.70 Score on a scale | Standard Deviation 23.22 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Utility | 64.09 Score on a scale | Standard Deviation 21.07 |
| Prosthetic Knee Joint - MPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Well Being | 62.00 Score on a scale | Standard Deviation 22.18 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Frustration | 56.29 Score on a scale | Standard Deviation 28.83 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Ambulation | 45.31 Score on a scale | Standard Deviation 20.94 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Sounds | 85.13 Score on a scale | Standard Deviation 16.91 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Appearance | 62.80 Score on a scale | Standard Deviation 19.37 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Well Being | 61.10 Score on a scale | Standard Deviation 20.28 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Residual Limb Health | 76.31 Score on a scale | Standard Deviation 18.56 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Perceived Response | 90.00 Score on a scale | Standard Deviation 9.91 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Utility | 52.52 Score on a scale | Standard Deviation 14.18 |
| Prosthetic Knee Joint - NMPK | Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ) | Social Burden | 66.06 Score on a scale | Standard Deviation 29.15 |
p-value: 0.01ANOVA