Trial Outcomes & Findings for Functional Outcomes in Dysvascular Transfemoral Amputees (NCT NCT01537211)

NCT ID: NCT01537211

Last Updated: 2019-09-06

Results Overview

The difference in social mobility (as seen by GPS) between the 2 devices will be measured.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: baseline, 1 month with mechanical knee, 1 month with microprocessor knee
• Results posted on: 2019-09-06

Participant Flow

Participant milestones

Measure	Microprocessor Knee Then Mechanical Knee C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees	Mechanical Knee Then Microprocessor Knee C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees
Overall Study STARTED	4	6
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Microprocessor Knee Then Mechanical Knee C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees	Mechanical Knee Then Microprocessor Knee C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Microprocessor Knee Then Mechanical Knee n=4 Participants C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees	Mechanical Knee Then Microprocessor Knee n=6 Participants C leg compared to subject's mechanical leg (Otto Bock): comparison of different prosthetic knees	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=4 Participants	4 Participants n=6 Participants	5 Participants n=10 Participants
Age, Categorical >=65 years	3 Participants n=4 Participants	2 Participants n=6 Participants	5 Participants n=10 Participants
Age, Continuous	67.9 years STANDARD_DEVIATION 9.7 • n=4 Participants	60.5 years STANDARD_DEVIATION 7.5 • n=6 Participants	63.4 years STANDARD_DEVIATION 8.8 • n=10 Participants
Sex: Female, Male Female	3 Participants n=4 Participants	3 Participants n=6 Participants	6 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=4 Participants	3 Participants n=6 Participants	4 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	4 participants n=4 Participants	6 participants n=6 Participants	10 participants n=10 Participants

PRIMARY outcome

Timeframe: baseline, 1 month with mechanical knee, 1 month with microprocessor knee

The difference in social mobility (as seen by GPS) between the 2 devices will be measured.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=10 Participants Data collected from while participants used the microprocessor knee
Change in Community Physical Activity as Measured by GPS	1749 Steps per day Standard Deviation 2072	1625 Steps per day Standard Deviation 1150	1257 Steps per day Standard Deviation 1164

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in 6 Minute Walk Test From Baseline	434.0 Feet Standard Deviation 270.3	472.2 Feet Standard Deviation 348.6	476.4 Feet Standard Deviation 361.9

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in 10 Meter Walk Test Gait Speed From Baseline	0.483 meters per second Standard Deviation 0.152	0.645 meters per second Standard Deviation 0.273	0.764 meters per second Standard Deviation 0.282

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in Amputee Mobility Predictor Score From Baseline	30 score on a scale Standard Deviation 8	34 score on a scale Standard Deviation 6	36 score on a scale Standard Deviation 5

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in Berg Balance Score From Baseline	35 score on a scale Standard Deviation 10	39 score on a scale Standard Deviation 14	44 score on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in Timed Up and Go Test Time From Baseline	29.95 seconds Standard Deviation 16.14	29.91 seconds Standard Deviation 15.61	25.32 seconds Standard Deviation 14.14

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in Four Square Step Test Time From Baseline	17.96 seconds Standard Deviation 5.11	19.74 seconds Standard Deviation 11.72	16.79 seconds Standard Deviation 11.17

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in Modified Falls Efficacy Scale From Baseline	7.58 score on a scale Standard Deviation 1.24	8.61 score on a scale Standard Deviation 1.02	9.33 score on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in Community Participation Indicators From Baseline Involvement in Life Situations	49.26 score on a scale Standard Deviation 7.23	50.16 score on a scale Standard Deviation 6.25	55.83 score on a scale Standard Deviation 18.99
Change in Community Participation Indicators From Baseline Control over Participation	61.68 score on a scale Standard Deviation 10.57	65.28 score on a scale Standard Deviation 10.24	74.69 score on a scale Standard Deviation 18.67
Change in Community Participation Indicators From Baseline Percent Social Activities Performed Often Enough	67.19 score on a scale Standard Deviation 28.66	68.62 score on a scale Standard Deviation 33.99	72.19 score on a scale Standard Deviation 34.59
Change in Community Participation Indicators From Baseline Percent Productive Activities Performed Enough	62.96 score on a scale Standard Deviation 39.55	76.17 score on a scale Standard Deviation 26.18	72.96 score on a scale Standard Deviation 32.55
Change in Community Participation Indicators From Baseline Percent Low-Frequency Activities Performed Enough	57.88 score on a scale Standard Deviation 33.51	61.43 score on a scale Standard Deviation 41.40	64.79 score on a scale Standard Deviation 35.87
Change in Community Participation Indicators From Baseline Total Percent of Activities Performed Enough	63.91 score on a scale Standard Deviation 22.51	68.74 score on a scale Standard Deviation 27.97	69.98 score on a scale Standard Deviation 25.06

SECONDARY outcome

Timeframe: After 3 month acclimation period to device

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.

Outcome measures

Measure	Baseline n=10 Participants Baseline data for participants using their own prosthesis	Mechanical Knee n=10 Participants Data collected from while participants used the mechanical knee	Microprocessor Knee n=9 Participants Data collected from while participants used the microprocessor knee
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Ambulation	58.64 score on a scale Standard Deviation 18.76	58.28 score on a scale Standard Deviation 18.41	81.92 score on a scale Standard Deviation 18.74
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Appearance	69.80 score on a scale Standard Deviation 19.86	68.78 score on a scale Standard Deviation 15.23	85.91 score on a scale Standard Deviation 9.32
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Frustration	80.8 score on a scale Standard Deviation 21.6	64.1 score on a scale Standard Deviation 28.2	90.2 score on a scale Standard Deviation 9.2
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Perceived Response	83.81 score on a scale Standard Deviation 13.42	87.39 score on a scale Standard Deviation 10.73	88.86 score on a scale Standard Deviation 13.39
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Residual Limb Health	82.8 score on a scale Standard Deviation 15.1	79.9 score on a scale Standard Deviation 8.9	85.1 score on a scale Standard Deviation 8.8
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Social Burdern	70.59 score on a scale Standard Deviation 23.52	76.08 score on a scale Standard Deviation 22.73	88.72 score on a scale Standard Deviation 15.92
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Sounds	74.20 score on a scale Standard Deviation 25.88	72.60 score on a scale Standard Deviation 30.49	93.50 score on a scale Standard Deviation 6.62
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Utility	67.80 score on a scale Standard Deviation 18.59	67.02 score on a scale Standard Deviation 17.92	83.92 score on a scale Standard Deviation 11.09
Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline Well Being	70.05 score on a scale Standard Deviation 25.63	79.00 score on a scale Standard Deviation 18.81	85.44 score on a scale Standard Deviation 10.75

Adverse Events

Microprocessor Knee

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mechanical Knee

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes

Rehabilitation Institute of Chicago

Phone: 3122386875

Email: ajayaraman@ricres.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place