Trial Outcomes & Findings for Personalizing MPK Prescription (NCT NCT06399471)
NCT ID: NCT06399471
Last Updated: 2024-11-14
Results Overview
Self selected walking speed over ten meters of walking over ground.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
1 month
Results posted on
2024-11-14
Participant Flow
Knee condition order was randomized prior to enrollment.
Unit of analysis: Prosthetic Knee
Participant milestones
| Measure |
Prosthetic Knee Randomized
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Overall Study
STARTED
|
11 31
|
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Overall Study
Ottobock C-Leg 4.0
|
10 10
|
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Overall Study
Ossur Power Knee
|
11 11
|
|
Overall Study
Ossur Rheo
|
10 10
|
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Overall Study
COMPLETED
|
10 30
|
|
Overall Study
NOT COMPLETED
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1 1
|
Reasons for withdrawal
| Measure |
Prosthetic Knee Randomized
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Data was not collected from the one participant who did not complete the study.
Baseline characteristics by cohort
| Measure |
Study Microprocessor Prosthetic Knee
n=11 Participants
Randomization to C-Leg 4.0, Rheo Knee and Power Knee
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
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1 Participants
n=11 Participants
|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 10.4 • n=11 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
|
Height
|
1.75 Meters
STANDARD_DEVIATION 0.11 • n=11 Participants
|
|
Weight
|
82.5 Kilograms
STANDARD_DEVIATION 16.3 • n=11 Participants
|
|
AMPnoPro
|
38.1 units on a scale
STANDARD_DEVIATION 3.9 • n=10 Participants • Data was not collected from the one participant who did not complete the study.
|
|
Clinically Prescribed Prosthetic Knee
Otto Bock C-Leg
|
7 Participants
n=11 Participants
|
|
Clinically Prescribed Prosthetic Knee
Otto Bock X3
|
1 Participants
n=11 Participants
|
|
Clinically Prescribed Prosthetic Knee
Plie
|
2 Participants
n=11 Participants
|
|
Clinically Prescribed Prosthetic Knee
Proteor Quattro
|
1 Participants
n=11 Participants
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PRIMARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
Self selected walking speed over ten meters of walking over ground.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Ten Meter Walking Test
Power Knee
|
0.9963 Meters per second
Standard Deviation 0.2061
|
|
Ten Meter Walking Test
C-Leg 4.0
|
1.1051 Meters per second
Standard Deviation 0.2081
|
|
Ten Meter Walking Test
Rheo
|
1.1111 Meters per second
Standard Deviation 0.201
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
Self selected walking speed over two minutes of walking over ground.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Two Minute Walking Test
Power Knee
|
1.073 Meters per second
Standard Deviation 0.2415
|
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Two Minute Walking Test
C-Leg 4.0
|
1.2106 Meters per second
Standard Deviation 0.2025
|
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Two Minute Walking Test
Rheo
|
1.1698 Meters per second
Standard Deviation 0.2458
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PRIMARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
A patient reported survey on perceptions of a prosthesis. Scores range zero to one hundred with zero being representing a negative patient reported outcome and one hundred representing a positive patient reported outcome.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Prosthetic Evaluation Questionnaire (PEQ)
Power Knee
|
69.4 units on a scale
Standard Deviation 8.99
|
|
Prosthetic Evaluation Questionnaire (PEQ)
C-Leg 4.0
|
83.2 units on a scale
Standard Deviation 10.15
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Rheo
|
78.4 units on a scale
Standard Deviation 11.75
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SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
Stance time asymmetry index measures the percent difference in stance time between the prosthetic and sound side limbs. A value equal to zero is indicative of perfect symmetry. Negative values of ST asymmetry index are indicative of increased time spent on the sound side and positive values are indicative of increased time on the prosthetic side.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Stance Time Asymmetry Index
Rheo
|
-7.03 percentage of stance time
Standard Deviation 8.13
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Stance Time Asymmetry Index
Power Knee
|
-10.15 percentage of stance time
Standard Deviation 3.68
|
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Stance Time Asymmetry Index
C-Leg 4.0
|
-10.95 percentage of stance time
Standard Deviation 9.98
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SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
A measure of balance via walking down a narrowing beam.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Narrowing Beam Walking Test
Power Knee
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11.3 Feet
Standard Deviation 3.14
|
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Narrowing Beam Walking Test
C-Leg 4.0
|
12.6 Feet
Standard Deviation 2.80
|
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Narrowing Beam Walking Test
Rheo
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13.5 Feet
Standard Deviation 2.64
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SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
Average reported falls per day.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Reported Falls
Power Knee
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0.06429 Falls per day
Standard Deviation 0.10326
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Reported Falls
C-Leg 4.0
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0.04286 Falls per day
Standard Deviation 0.06547
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Reported Falls
Rheo
|
0.01429 Falls per day
Standard Deviation 0.04286
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SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
A clinical measure of energy expenditure. This formula consists of working heart minus resting heart rate divided by speed.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Physiological Cost Index
Power Knee
|
0.29 Heart beats per meter
Standard Deviation 0.1034
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Physiological Cost Index
C-Leg 4.0
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0.25 Heart beats per meter
Standard Deviation 0.0593
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Physiological Cost Index
Rheo
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0.27 Heart beats per meter
Standard Deviation 0.0984
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SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
Self selected walking speed during stair ascent.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Stair Ascent Speed
Power Knee
|
50.463 Steps per minute
Standard Deviation 7.9767
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Stair Ascent Speed
C-Leg 4.0
|
56.336 Steps per minute
Standard Deviation 17.494
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Stair Ascent Speed
Rheo
|
48.336 Steps per minute
Standard Deviation 7.1067
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SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
Self selected walking speed while descending stairs.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Stair Descent Speed
Power Knee
|
92.65 Steps per minute
Standard Deviation 25.67
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Stair Descent Speed
C-Leg 4.0
|
93.997 Steps per minute
Standard Deviation 27.183
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Stair Descent Speed
Rheo
|
88.3 Steps per minute
Standard Deviation 21.261
|
SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
Self selected walking speed while ascending a 5 degree incline.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
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Ramp Ascent Speed
Power Knee
|
0.8929 Meters per second
Standard Deviation 0.1533
|
|
Ramp Ascent Speed
C-Leg 4.0
|
0.969 Meters per second
Standard Deviation 0.2086
|
|
Ramp Ascent Speed
Rheo
|
0.971 Meters per second
Standard Deviation 0.1754
|
SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.
Self selected walking speed while descending a 5 degree incline.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=30 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
|
Ramp Descent Speed
Power Knee
|
0.7643 Meters per second
Standard Deviation 0.1675
|
|
Ramp Descent Speed
C-Leg 4.0
|
0.869 Meters per second
Standard Deviation 0.2282
|
|
Ramp Descent Speed
Rheo
|
0.8584 Meters per second
Standard Deviation 0.2436
|
SECONDARY outcome
Timeframe: 1 monthPopulation: 1 participant did not complete any of the conditions due to self withdrawal after consenting. No data obtained from two participants due to experimental error. Each participant wore all three knees during this trial.
Steps per day as measured by StepWatch.
Outcome measures
| Measure |
Prosthetic Knee Randomized
n=24 Prosthetic Knees
Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee.
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|---|---|
|
Steps Per Day
Power Knee
|
2620.1 Steps per day
Standard Deviation 705.5
|
|
Steps Per Day
C-Leg 4.0
|
2762.6 Steps per day
Standard Deviation 969.2
|
|
Steps Per Day
Rheo
|
2462.6 Steps per day
Standard Deviation 1030.2
|
Adverse Events
Ottobock C-Leg 4.0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ossur Rheo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ossur Power 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
Kinsey Herrin, MSPO, C/LPO, FAAOP, Senior Research Scientist
Georgia Institute of Technology
Phone: 470-578-7600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place