Trial Outcomes & Findings for Intent Recognition for Prosthesis Control (NCT NCT05537792)
NCT ID: NCT05537792
Last Updated: 2024-10-02
Results Overview
This measures the individuals preferred overground walking speed which indicates their physical capability with a device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 day
Results posted on
2024-10-02
Participant Flow
Participant milestones
| Measure |
Smart Robotic Knee/Ankle Prothesis
This study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures).
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intent Recognition for Prosthesis Control
Baseline characteristics by cohort
| Measure |
Smart Robotic Knee/Ankle Prothesis
n=10 Participants
This study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures).
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
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42.4 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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10 participants
n=5 Participants
|
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Height
|
1.69 Meters
STANDARD_DEVIATION 0.10 • n=5 Participants
|
|
Weight
|
71.83 Kilograms
STANDARD_DEVIATION 14.66 • n=5 Participants
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|
Amputated Side
Amputated Side Right
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6 Participants
n=5 Participants
|
|
Amputated Side
Amputated Side Left
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4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayThis measures the individuals preferred overground walking speed which indicates their physical capability with a device.
Outcome measures
| Measure |
Smart Robotic Knee/Ankle Prothesis
n=10 Participants
This study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures).
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 1 Inertial Measurement Unit Adapted Forward Estimator
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 inertial measurement unit adapted forward estimator arm, each participant will test the prosthesis with an adapted control system using a foot inertial measurement unit with discrete treadmill speed profiles following a staircase profile. In this treadmill speed profile participants walk at discrete speeds of 0.3, 0.5, 0.7, 0.9, 0.8, 0.6, 0.4 m/s. Each speed was maintained for 20 seconds before transitioning to the next speed at an acceleration of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 1 Ground Truth Adapted Forward Estimator
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 Ground Truth arm, each participant will test the prosthesis with an adapted control system using ground truth treadmill speeds (directly read from the treadmill controller) with treadmill speed profiles following a staircase profile. In this treadmill speed profile participants walk at discrete speeds of 0.3, 0.5, 0.7, 0.9, 0.8, 0.6, 0.4 m/s. Each speed was maintained for 20 seconds before transitioning to the next speed at an acceleration of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 2 Inertial Measurement Unit Adapted Forward Estimator
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 2 inertial measurement unit adapted forward estimator arm, each participant will test the prosthesis with an adapted control system using a foot inertial measurement unit with treadmill speed profiles following a triangular profile such that the treadmill speed started at 0.3 m/s, accelerated to 0.9 m/s, and then decelerated back to 0.3 m/s at a rate of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 2 Ground Truth Adapted Forward Estimator
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 Ground Truth arm,each participant will test the prosthesis with an adapted control system using ground truth treadmill speeds (directly read from the treadmill controller) with treadmill speed profiles following a triangular profile such that the treadmill speed started at 0.3 m/s, accelerated to 0.9 m/s, and then decelerated back to 0.3 m/s at a rate of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
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|---|---|---|---|---|---|
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Overground Self-selected Walking Speed
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0.695 Meters per second
Standard Deviation 0.136
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 1 dayThis outcome is the error with which the machine learning model embedded into our advanced prosthesis controller's microprocessor predicts the user's walking speed overground. Specifically, mean absolute error (MAE) is computed between the predicted walking speed and the ground truth walking speed, or the speed that the user is actually walking at. Ground truth measurements are measured by a motion-capture system and taken to be center of mass speed. Walking speed predictions are made every 50 ms and compared to the nearest center-of-mass speed. For this measure, lower walking speed MAEs are indicative of greater accuracy in defining the user's true walking speed and thus lower numbers are indicative of an improved outcome.
Outcome measures
| Measure |
Smart Robotic Knee/Ankle Prothesis
n=10 Participants
This study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures).
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 1 Inertial Measurement Unit Adapted Forward Estimator
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 inertial measurement unit adapted forward estimator arm, each participant will test the prosthesis with an adapted control system using a foot inertial measurement unit with discrete treadmill speed profiles following a staircase profile. In this treadmill speed profile participants walk at discrete speeds of 0.3, 0.5, 0.7, 0.9, 0.8, 0.6, 0.4 m/s. Each speed was maintained for 20 seconds before transitioning to the next speed at an acceleration of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 1 Ground Truth Adapted Forward Estimator
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 Ground Truth arm, each participant will test the prosthesis with an adapted control system using ground truth treadmill speeds (directly read from the treadmill controller) with treadmill speed profiles following a staircase profile. In this treadmill speed profile participants walk at discrete speeds of 0.3, 0.5, 0.7, 0.9, 0.8, 0.6, 0.4 m/s. Each speed was maintained for 20 seconds before transitioning to the next speed at an acceleration of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 2 Inertial Measurement Unit Adapted Forward Estimator
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 2 inertial measurement unit adapted forward estimator arm, each participant will test the prosthesis with an adapted control system using a foot inertial measurement unit with treadmill speed profiles following a triangular profile such that the treadmill speed started at 0.3 m/s, accelerated to 0.9 m/s, and then decelerated back to 0.3 m/s at a rate of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 2 Ground Truth Adapted Forward Estimator
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 Ground Truth arm,each participant will test the prosthesis with an adapted control system using ground truth treadmill speeds (directly read from the treadmill controller) with treadmill speed profiles following a triangular profile such that the treadmill speed started at 0.3 m/s, accelerated to 0.9 m/s, and then decelerated back to 0.3 m/s at a rate of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
|---|---|---|---|---|---|
|
Overground Walking Speed Mean Absolute Error (MAE)
|
0.142 Mean Absolute Error for Meter per second
Standard Deviation 0.035
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayThis outcome is the error with which the machine learning model embedded into our advanced prosthesis controller's microprocessor predicts the user's walking speed on the treadmill. Specifically, mean absolute error (MAE) is computed between the predicted walking speed and the ground truth walking speed, or the speed that the user is actually walking at. Ground truth measurements are measured by the true treadmill speed (for treadmill trials). Walking speed predictions are made every 50 ms and compared to the nearest center-of-mass speed. For this measure, lower walking speed MAEs are indicative of greater accuracy in defining the user's true walking speed and thus lower numbers are indicative of an improved outcome.
Outcome measures
| Measure |
Smart Robotic Knee/Ankle Prothesis
n=10 Participants
This study will be conducted on a sample population of individuals with transfemoral amputation (single arm). Each participant will test with each condition of the study (repeated measures).
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 1 Inertial Measurement Unit Adapted Forward Estimator
n=10 Participants
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 inertial measurement unit adapted forward estimator arm, each participant will test the prosthesis with an adapted control system using a foot inertial measurement unit with discrete treadmill speed profiles following a staircase profile. In this treadmill speed profile participants walk at discrete speeds of 0.3, 0.5, 0.7, 0.9, 0.8, 0.6, 0.4 m/s. Each speed was maintained for 20 seconds before transitioning to the next speed at an acceleration of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 1 Ground Truth Adapted Forward Estimator
n=10 Participants
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 Ground Truth arm, each participant will test the prosthesis with an adapted control system using ground truth treadmill speeds (directly read from the treadmill controller) with treadmill speed profiles following a staircase profile. In this treadmill speed profile participants walk at discrete speeds of 0.3, 0.5, 0.7, 0.9, 0.8, 0.6, 0.4 m/s. Each speed was maintained for 20 seconds before transitioning to the next speed at an acceleration of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 2 Inertial Measurement Unit Adapted Forward Estimator
n=10 Participants
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 2 inertial measurement unit adapted forward estimator arm, each participant will test the prosthesis with an adapted control system using a foot inertial measurement unit with treadmill speed profiles following a triangular profile such that the treadmill speed started at 0.3 m/s, accelerated to 0.9 m/s, and then decelerated back to 0.3 m/s at a rate of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
Profile 2 Ground Truth Adapted Forward Estimator
n=10 Participants
This study will be conducted on a sample population of individuals with transfemoral amputation. In the Profile 1 Ground Truth arm,each participant will test the prosthesis with an adapted control system using ground truth treadmill speeds (directly read from the treadmill controller) with treadmill speed profiles following a triangular profile such that the treadmill speed started at 0.3 m/s, accelerated to 0.9 m/s, and then decelerated back to 0.3 m/s at a rate of 0.1 meters per second squared.
Robotic Knee/Ankle Prosthesis: The intervention is an experimental robotic knee/ankle prosthesis that has been previously developed by the team. It is used to improve walking gait performance.
|
|---|---|---|---|---|---|
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Treadmill Walking Speed Mean Absolute Error (MAE)
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0.158 Mean Absolute Error for Meter per second
Standard Deviation 0.037
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0.155 Mean Absolute Error for Meter per second
Standard Deviation 0.038
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0.139 Mean Absolute Error for Meter per second
Standard Deviation 0.039
|
0.163 Mean Absolute Error for Meter per second
Standard Deviation 0.045
|
0.138 Mean Absolute Error for Meter per second
Standard Deviation 0.028
|
Adverse Events
Smart Robotic Knee/Ankle Prothesis
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place