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| Name | Class |
|---|---|
| Otto Bock Healthcare | INDUSTRY |
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In older adults, poor circulation in the lower extremities leads to serious health complications including limb loss. In addition, individuals with dysvascular disease also suffer from other co-morbidities like diabetes, coronary and cerebrovascular disease. An individual with a transfemoral (TF) amputation is usually fitted with a prosthetic limb to assist with function, including a prosthetic knee and a prosthetic foot. Currently, dysvascular amputees are given a prosthetic knee based on the basic expectation that they will be functionally stable. This consideration does not address higher levels of function like walking at multiple speeds and over uneven ground. Also, dysvascular amputees are not able to counteract their co-morbidities with a more active lifestyle. Walking is less energy efficient; their traditional prostheses may cause early onset of fatigue and induce a fear of falling. Newer microprocessor knees enable patients with transfemoral amputations to walk on different surfaces and at multiple cadences through better control in swing and stance phases of gait. The impact of the functional differences in the prostheses is not clear and requires additional investigation to clarify the choice of the most appropriate functional prosthesis. The purpose of this study is to compare the functional outcomes with the traditional mechanical knee versus the microprocessor knee (C-leg) in transfemoral amputees.
In older adults, poor circulation in the lower extremities or dysvascular disease can lead to serious health complications. In addition, these individuals also suffer from serious co-morbidities like diabetes and coronary or cerebrovascular disease. Circulatory dysfunction or dysvascular disease is the major cause for amputations in the United States (www.amputee-coalition.orf/fact\_sheet/amp\_stats\_cause.html). Increasing sedentary lifestyles have lead to increased rates of diabetes which has significantly contributed to an increased number of amputations in recent years. The risk of amputation in a diabetic individual is 25 times higher than in the non-diabetic population. The level of amputation that is appropriate for an individual depends on the extent of damage to his/her tissues. Common amputations of the lower extremities in the dysvascular population include the transtibial and transfemoral amputations. The individual having a transtibial or below knee amputation, will be fitted with a prosthetic foot to assist with functional ambulation, while a person with a transfemoral amputation will require both a prosthetic foot and knee for ambulatory purposes. Currently dysvascular amputees are given prostheses based on the goal of returning them to a basic level of function focused primarily on stability. They are considered lower functioning walkers and are expected to use a slow and constant walking speed to ambulate around their homes and are not considered traditional community ambulators. Therefore, they are traditionally given standard mechanical knees which are considered safe, as they provide the ability for only simple single speed house-hold tasks. While this criterion does return the patient to function for basic Activities of Daily Living (ADLs) and walking at a single cadence, it does not empower the patient to counteract the previously existing co-morbidities. Dysvascular amputees tend to be less active predisposing them to a more sedentary lifestyle and exacerbating their risk factors. Their prostheses make them energy inefficient and use more energy for ADLs and functional walking. This causes early onset of fatigue, induces anxiety and fear of falling. Further, they are often depressed, lose motivation and curtail their community interaction. This raises the question if dysvascular amputees are further functionally limited by the prostheses traditionally given to them.
More recently, technology has been used to assist with return to function in the amputee population. Microprocessor (MP) controlled knees are among the technological innovations applied to prostheses to not only return amputees to a basic function, but also with a view to return them to their highest possible function. Over the years, clinical use has shown that traditional knees provide the ability to complete ADLs and basic functions like sit - stand. However, activities like negotiating stairs/steps, walking on uneven ground and self-correction during tripping; functions which reintegrate amputees into unlimited community ambulation and social reintegration require prosthetics which advanced functionality. The Otto Bock C-leg is a MP knee that allows the patient a greater level of control in swing and stance phases of gait. This enables the TF amputee to adjust the requirements of gait during dynamic walking like changing the speed of walking, going up and down stairs and inclines, walking on grass and uneven surfaces and crossing an obstacle. The C-leg has been traditionally given to patients who begin post-amputation rehabilitation at a higher level, but are more expensive than traditionally mechanical knees. In the contrary however, a European study that defined health outcomes in terms of quality-adjusted life year (QALY), indicated that the C-leg showed a QALY gain of €3218 per patient, makes it still financial viable keeping it mind its price tag.. The purpose of this study is to compare the traditional mechanical knee to the microprocessor knee (C-leg) in the dysvascular population. The study will specifically evaluate the potential of microprocessor knees to improve the quality of life in dysvascular transfemoral amputees. This includes identifying if the C-leg can increase the activity level to be classified at a higher level by the Medicare classification from K2 (lower level ambulators) to K3 (more proficient ambulators), along with increasing their social interaction in the community.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microprocessor knee then Mechanical knee | Experimental |
| |
| Mechanical Knee then Microprocessor knee | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C leg compared to subject's mechanical leg (Otto Bock) | Device | comparison of different prosthetic knees |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Community Physical Activity as Measured by GPS | The difference in social mobility (as seen by GPS) between the 2 devices will be measured. | baseline, 1 month with mechanical knee, 1 month with microprocessor knee |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 Minute Walk Test From Baseline | The 6 Minute Walk Test (6MWT) is an endurance test, which measures the distance a subject can walk indoors on a flat, hard surface over a period of 6 minutes, using assistive devices as necessary. The distance covered during the test is measured with a measuring wheel. | After 3 month acclimation period to device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun Jayaraman, PT PhD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Institute of Chicago, 345 E Superior St | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21947182 | Background | Theeven P, Hemmen B, Rings F, Meys G, Brink P, Smeets R, Seelen H. Functional added value of microprocessor-controlled knee joints in daily life performance of Medicare Functional Classification Level-2 amputees. J Rehabil Med. 2011 Oct;43(10):906-15. doi: 10.2340/16501977-0861. | |
| 34034753 | Derived | Jayaraman C, Mummidisetty CK, Albert MV, Lipschutz R, Hoppe-Ludwig S, Mathur G, Jayaraman A. Using a microprocessor knee (C-Leg) with appropriate foot transitioned individuals with dysvascular transfemoral amputations to higher performance levels: a longitudinal randomized clinical trial. J Neuroeng Rehabil. 2021 May 25;18(1):88. doi: 10.1186/s12984-021-00879-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Microprocessor Knee Then Mechanical Knee | C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees |
| FG001 | Mechanical Knee Then Microprocessor Knee | C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Microprocessor Knee Then Mechanical Knee | C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees |
| BG001 | Mechanical Knee Then Microprocessor Knee |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Community Physical Activity as Measured by GPS | The difference in social mobility (as seen by GPS) between the 2 devices will be measured. | Posted | Mean | Standard Deviation | Steps per day | baseline, 1 month with mechanical knee, 1 month with microprocessor knee |
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Adverse events were monitored/assessed, before and after every data collection session, through study completion, up to 12 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 | Microprocessor Knee | The arm reflects time during study participation when the participants were wearing the microprocessor knee. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes | Rehabilitation Institute of Chicago | 3122386875 | ajayaraman@ricres.org |
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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 | Apr 17, 2018 | May 2, 2019 | Prot_SAP_000.pdf |
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| C leg compared to subject's mechanical leg (Otto Bock) | Device | comparison of different prosthetic knees |
|
|
| Change in 10 Meter Walk Test Gait Speed From Baseline | Measure of self selected walking speed by measuring the time it takes an individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. | After 3 month acclimation period to device |
| Change in Amputee Mobility Predictor Score From Baseline | The Amputee Mobility Predictor (AMP) instrument is used to asses the functional mobility through a standardized sequence of mobility tests while using the prosthesis. Individual tasks are scored and combined, resulting in a total assessment, which is scored out of 47. The minimum score is zero and maximum score on this scale is 47. Higher scores indicate better mobility. | After 3 month acclimation period to device |
| Change in Berg Balance Score From Baseline | The Berg balance scale is used to assess balance during functional activities. It is a performance-based tool, scored between 0 and 56 with higher numbers indicating better balance. | After 3 month acclimation period to device |
| Change in Timed Up and Go Test Time From Baseline | The Timed Up and Go (TUG) test is administered to quantify fall risk and functional mobility. TUG is the time taken for the subject to get up from a chair, walk 3 meters, and sit down. The time for the test to be completed is reported in seconds. | After 3 month acclimation period to device |
| Change in Four Square Step Test Time From Baseline | The four square step test assesses stepping and change of direction. The subject is asked to walk in a sequence across canes arranged to form four squares. The time to complete the sequence is reported in seconds. | After 3 month acclimation period to device |
| Change in Modified Falls Efficacy Scale From Baseline | The Modified Falls Efficacy Scale is used to determine falls and near-falls. It is a self-reported 14-item questionnaire filled out by the subject. Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment. | After 3 month acclimation period to device |
| Change in Community Participation Indicators From Baseline | The Community Participation Indicators questionnaire will be used to determine community and social participation. It is self-reported outcome measure for community participation. Different questions within the questionnaire correspond to two different aspects of community participation: involvement in life situations and control over participation. These two items are reported first in the table below. The minimum score is 0, and the maximum score is 100. Higher values correspond to higher levels of community participation. These two aspects can be further broken down into percentages of productive activities, social activities, and low-frequency activities performed often enough (the remaining reported values). Each of these percentages has a minimum score of zero and a maximum score of 100, with higher percentages indicating greater satisfaction with the frequency to which the activities are performed. | After 3 month acclimation period to device |
| Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline | The Prosthesis Evaluation Questionnaire (PEQ) will be used to determine prosthesis preference. It is a questionnaire filled out by the subject that is sectioned into validated scales related to usage of the given prosthesis. These validated scales are ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, and well being. Items included in these scales are scored between a minimum score of 0 and a maximum score of 100. Reported below are the averages of the validated scales. Thus, the average of each scale has a maximum score of 100 and a minimum score of 0, with a larger value indicating a more positive response. | After 3 month acclimation period to device |
C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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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Data collected from while participants used the microprocessor knee
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| Secondary | Change in 6 Minute Walk Test From Baseline | The 6 Minute Walk Test (6MWT) is an endurance test, which measures the distance a subject can walk indoors on a flat, hard surface over a period of 6 minutes, using assistive devices as necessary. The distance covered during the test is measured with a measuring wheel. | Posted | Mean | Standard Deviation | Feet | After 3 month acclimation period to device |
|
|
|
| Secondary | Change in 10 Meter Walk Test Gait Speed From Baseline | Measure of self selected walking speed by measuring the time it takes an individual to walk 10 meters. The test is performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. | Posted | Mean | Standard Deviation | meters per second | After 3 month acclimation period to device |
|
|
|
| Secondary | Change in Amputee Mobility Predictor Score From Baseline | The Amputee Mobility Predictor (AMP) instrument is used to asses the functional mobility through a standardized sequence of mobility tests while using the prosthesis. Individual tasks are scored and combined, resulting in a total assessment, which is scored out of 47. The minimum score is zero and maximum score on this scale is 47. Higher scores indicate better mobility. | Posted | Mean | Standard Deviation | score on a scale | After 3 month acclimation period to device |
|
|
|
| Secondary | Change in Berg Balance Score From Baseline | The Berg balance scale is used to assess balance during functional activities. It is a performance-based tool, scored between 0 and 56 with higher numbers indicating better balance. | Posted | Mean | Standard Deviation | score on a scale | After 3 month acclimation period to device |
|
|
|
| Secondary | Change in Timed Up and Go Test Time From Baseline | The Timed Up and Go (TUG) test is administered to quantify fall risk and functional mobility. TUG is the time taken for the subject to get up from a chair, walk 3 meters, and sit down. The time for the test to be completed is reported in seconds. | Posted | Mean | Standard Deviation | seconds | After 3 month acclimation period to device |
|
|
|
| Secondary | Change in Four Square Step Test Time From Baseline | The four square step test assesses stepping and change of direction. The subject is asked to walk in a sequence across canes arranged to form four squares. The time to complete the sequence is reported in seconds. | Posted | Mean | Standard Deviation | seconds | After 3 month acclimation period to device |
|
|
|
| Secondary | Change in Modified Falls Efficacy Scale From Baseline | The Modified Falls Efficacy Scale is used to determine falls and near-falls. It is a self-reported 14-item questionnaire filled out by the subject. Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment. | Posted | Mean | Standard Deviation | score on a scale | After 3 month acclimation period to device |
|
|
|
| Secondary | Change in Community Participation Indicators From Baseline | The Community Participation Indicators questionnaire will be used to determine community and social participation. It is self-reported outcome measure for community participation. Different questions within the questionnaire correspond to two different aspects of community participation: involvement in life situations and control over participation. These two items are reported first in the table below. The minimum score is 0, and the maximum score is 100. Higher values correspond to higher levels of community participation. These two aspects can be further broken down into percentages of productive activities, social activities, and low-frequency activities performed often enough (the remaining reported values). Each of these percentages has a minimum score of zero and a maximum score of 100, with higher percentages indicating greater satisfaction with the frequency to which the activities are performed. | Posted | Mean | Standard Deviation | score on a scale | After 3 month acclimation period to device |
|
|
|
| Secondary | Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline | The Prosthesis Evaluation Questionnaire (PEQ) will be used to determine prosthesis preference. It is a questionnaire filled out by the subject that is sectioned into validated scales related to usage of the given prosthesis. These validated scales are ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, and well being. Items included in these scales are scored between a minimum score of 0 and a maximum score of 100. Reported below are the averages of the validated scales. Thus, the average of each scale has a maximum score of 100 and a minimum score of 0, with a larger value indicating a more positive response. | Posted | Mean | Standard Deviation | score on a scale | After 3 month acclimation period to device |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Mechanical Knee | The arm reflects time during study participation when the participants were wearing the mechanical knee. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Percent Social Activities Performed Often Enough |
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| Percent Productive Activities Performed Enough |
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| Percent Low-Frequency Activities Performed Enough |
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| Total Percent of Activities Performed Enough |
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| Frustration |
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| Perceived Response |
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| Residual Limb Health |
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| Social Burdern |
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| Sounds |
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| Utility |
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| Well Being |
|