Trial Outcomes & Findings for Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees (NCT NCT06620861)
NCT ID: NCT06620861
Last Updated: 2026-01-30
Results Overview
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing sit to stand activity
TERMINATED
NA
6 participants
after acclimatization at day 1 during the single study event
2026-01-30
Participant Flow
6 subjects with transfemoral amputation provided informed consent and were formally enrolled in the study, as reflected in the Protocol Section (6). However, one enrolled subject did not proceed to randomization due to low activity level and fatigue, and therefore did not start the intervention. As a result, only 5 participants were assigned to an Arm/Group and included in the Participant Flow module (5), and their data are presented in the Baseline Characteristics and analysis.
Participant milestones
| Measure |
Current Marketed Firmware Before New Firmware
Group A will start with the current marketed firmware.
Power Knee Firmware Update: The firmware in development will be uploaded to the device.
Power Knee Current Marketed Firmware: The current marketed firmware will be uploaded to the device.
|
New Firmware Before Current Marketed Firmware
Group B will start with the firmware in development.
Power Knee Firmware Update: The firmware in development will be uploaded to the device.
Power Knee Current Marketed Firmware: The current marketed firmware will be uploaded to the device.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis.
Baseline characteristics by cohort
| Measure |
Combined Crossover Evaluation Group
n=5 Participants
For the analysis, data from both participant groups were pooled. Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware.
Power Knee Firmware Update: The investigational (new) firmware was installed on the device.
Power Knee Current Marketed Firmware: The existing marketed firmware was installed on the device.
In Group A, participants first used the current marketed firmware before switching to the investigational firmware.
In Group B, participants first used the investigational firmware before switching to the current marketed firmware.
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|---|---|
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Age, Continuous
|
55.4 years
STANDARD_DEVIATION 11.7 • n=5 Participants • One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis.
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants • One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis.
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants • One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis.
|
|
Amputation level Transfemoral
|
5 Participants
n=5 Participants • One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis.
|
PRIMARY outcome
Timeframe: after acclimatization at day 1 during the single study eventEach participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing sit to stand activity
Outcome measures
| Measure |
Current Marketed Firmware
n=5 Participants
Results obtained with the current marketed firmware.
|
New Investigational Firmware
Results obtained with the new investigational firmware.
|
|---|---|---|
|
Sit to Stand Activity
worse
|
1 Participants
|
—
|
|
Sit to Stand Activity
better
|
3 Participants
|
—
|
|
Sit to Stand Activity
similar
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: after acclimatization at day 1 during the single study eventEach participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stand to sit activity
Outcome measures
| Measure |
Current Marketed Firmware
n=5 Participants
Results obtained with the current marketed firmware.
|
New Investigational Firmware
Results obtained with the new investigational firmware.
|
|---|---|---|
|
Stand to Sit Activity
similar
|
3 Participants
|
—
|
|
Stand to Sit Activity
better
|
1 Participants
|
—
|
|
Stand to Sit Activity
worse
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: after acclimatization at day 1 during the single study eventEach participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing level ground walking.
Outcome measures
| Measure |
Current Marketed Firmware
n=5 Participants
Results obtained with the current marketed firmware.
|
New Investigational Firmware
Results obtained with the new investigational firmware.
|
|---|---|---|
|
Level Ground Walking
worse
|
2 Participants
|
—
|
|
Level Ground Walking
similar
|
1 Participants
|
—
|
|
Level Ground Walking
bettter
|
2 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: after acclimatization at day 1 during the single study eventPopulation: Only 2 subjects performed this test.
The 2-Minute Walk Test is a clinical assessment used to measure an individual's walking endurance and functional capacity. During the test, the participant is instructed to walk for 2 minutes at their comfortable pace along a marked course. The total distance walked within the 2-minute period is recorded (in meters).
Outcome measures
| Measure |
Current Marketed Firmware
n=2 Participants
Results obtained with the current marketed firmware.
|
New Investigational Firmware
n=2 Participants
Results obtained with the new investigational firmware.
|
|---|---|---|
|
2MWT
|
173.5 meters
Standard Deviation 19.1
|
179.5 meters
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: after acclimatization at day 1 during the single study eventPopulation: Only 4 subjects performed this test.
The 10-Meter Walk Test is a commonly used clinical assessment to measure an individual's walking speed over a short distance. During the test, the participant is asked to walk a distance of 10 meters at their fastest possible pace. The time taken to walk the 10 meters is recorded.
Outcome measures
| Measure |
Current Marketed Firmware
n=4 Participants
Results obtained with the current marketed firmware.
|
New Investigational Firmware
n=4 Participants
Results obtained with the new investigational firmware.
|
|---|---|---|
|
10mWT
|
6.91 seconds
Standard Deviation 1.14
|
6.61 seconds
Standard Deviation 1.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: after acclimatization at day 1 during the single study eventPopulation: Data for stair ascent activities (Outcome Measures 6-9) could not be reported because these activities were not tested during the study. The investigational firmware was not finalized in time for stair ascent, and therefore this activity was not included in the testing protocol. As a result, no data were collected for these Outcome Measures. In the protocol, data related to stair ascent was considered exploratory.
Stair assessment index (0-13)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: after acclimatization at day 1 during the single study eventPopulation: Data for stair ascent activities (Outcome Measures 6-9) could not be reported because these activities were not tested during the study. The investigational firmware was not finalized in time for stair ascent, and therefore this activity was not included in the testing protocol. As a result, no data were collected for these Outcome Measures. In the protocol, data related to stair ascent was considered exploratory.
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stair ascent (entering) activity
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: after acclimatization at day 1 during the single study eventPopulation: Data for stair ascent activities (Outcome Measures 6-9) could not be reported because these activities were not tested during the study. The investigational firmware was not finalized in time for stair ascent, and therefore this activity was not included in the testing protocol. As a result, no data were collected for these Outcome Measures. In the protocol, data related to stair ascent was considered exploratory.
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing the stair ascent (exiting) activity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: after acclimatization at day 1 during the single study eventPopulation: Data for stair ascent activities (Outcome Measures 6-9) could not be reported because these activities were not tested during the study. The investigational firmware was not finalized in time for stair ascent, and therefore this activity was not included in the testing protocol. As a result, no data were collected for these Outcome Measures. In the protocol, data related to stair ascent was considered exploratory.
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stair ascent activity
Outcome measures
Outcome data not reported
Adverse Events
Current Marketed Firmware Before New Firmware
New Firmware Before Current Marketed Firmware
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