Transfemoral Amputation Clinical Trial
— CLEGOfficial title:
Microprocessor Knee Versus Mechanical Knee: Impact on Functional Outcomes in Dysvascular Transfemoral Amputees
NCT number | NCT01537211 |
Other study ID # | STU00042823 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2011 |
Est. completion date | April 2019 |
Verified date | August 2019 |
Source | Shirley Ryan AbilityLab |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Males or females with dysvascular transfemoral amputations - 6 months or more post prosthetic fitting - Homebound or limited community ambulators post amputation - Ability to walk > 50m in a 2 min walk test Exclusion Criteria: - Traumatic, cancer or genetic amputation - Co-morbidity that completely prevents physical activity - Significant skin lesions/ulcers on stump that prevent fitting of prosthesis - Cognitive deficits or visual impairments that would impair their ability to give informed consent or to follow simple instructions during experiment |
Country | Name | City | State |
---|---|---|---|
United States | Rehabilitation Institute of Chicago, 345 E Superior St | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Shirley Ryan AbilityLab | Otto Bock Healthcare |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | baseline, 1 month with mechanical knee, 1 month with microprocessor knee | |
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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | After 3 month acclimation period to device |
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