Trial Outcomes & Findings for Assist-Knee: Energy-Harvesting Knee Prosthesis (NCT NCT04023045)
NCT ID: NCT04023045
Last Updated: 2023-10-18
Results Overview
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
COMPLETED
NA
3 participants
Collection at baseline
2023-10-18
Participant Flow
Individuals were recruited from a sample of convenience in the local area between 07/15/2019 and 02/26/2020.
Participant milestones
| Measure |
Habitual Prosthesis
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 1)
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 1: First set of settings tested on Assist-Knee with the participant.
|
Assist-Knee (Settings 2)
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
|---|---|---|---|
|
Habitual Prosthesis Condition
STARTED
|
3
|
0
|
0
|
|
Habitual Prosthesis Condition
COMPLETED
|
3
|
0
|
0
|
|
Habitual Prosthesis Condition
NOT COMPLETED
|
0
|
0
|
0
|
|
Assist-Knee (Settings 1) Condition
STARTED
|
0
|
3
|
0
|
|
Assist-Knee (Settings 1) Condition
COMPLETED
|
0
|
3
|
0
|
|
Assist-Knee (Settings 1) Condition
NOT COMPLETED
|
0
|
0
|
0
|
|
Assist-Knee (Settings 2) Condition
STARTED
|
0
|
0
|
3
|
|
Assist-Knee (Settings 2) Condition
COMPLETED
|
0
|
0
|
3
|
|
Assist-Knee (Settings 2) Condition
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assist-Knee: Energy-Harvesting Knee Prosthesis
Baseline characteristics by cohort
| Measure |
Study Participants
n=3 Participants
Study participants completed both arms of the study: Habitual and Assist-Knee.
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
Assist-Knee Prosthesis: Assist-Knee is an experimental lower limb knee prosthesis.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 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
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Collection at baselinePopulation: Each participant served as their own control in this analysis.
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
Outcome measures
| Measure |
Habitual Prosthesis
n=3 Participants
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 2)
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
SIT With Assist-Knee (Settings 2)
Contralateral limb weight distribution during stand-to-sit at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
STAND With Assist-Knee (Settings 2)
Contralateral limb weight distribution during sit-to-stand at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
|---|---|---|---|---|
|
Time to Complete Sit-to-Stand
Participant A
|
1.6 seconds
Standard Deviation 0.1
|
—
|
—
|
—
|
|
Time to Complete Sit-to-Stand
Participant B
|
2.2 seconds
Standard Deviation 0.2
|
—
|
—
|
—
|
|
Time to Complete Sit-to-Stand
Participant C
|
1.4 seconds
Standard Deviation 0.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)Population: Each participant served as their own control in this analysis.
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
Outcome measures
| Measure |
Habitual Prosthesis
n=3 Participants
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 2)
n=3 Participants
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
SIT With Assist-Knee (Settings 2)
Contralateral limb weight distribution during stand-to-sit at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
STAND With Assist-Knee (Settings 2)
Contralateral limb weight distribution during sit-to-stand at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
|---|---|---|---|---|
|
Time to Complete Sit-to-Stand
Participant A
|
3.4 seconds
Standard Deviation 0.6
|
2.7 seconds
Standard Deviation 0.2
|
—
|
—
|
|
Time to Complete Sit-to-Stand
Participant B
|
6.4 seconds
Standard Deviation 1.3
|
3.8 seconds
Standard Deviation 0.5
|
—
|
—
|
|
Time to Complete Sit-to-Stand
Participant C
|
2.4 seconds
Standard Deviation 0.5
|
2.9 seconds
Standard Deviation 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Collection at baselinePopulation: Each participant served as their own control in this analysis.
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant completed the TUG test for three trials. Time was measured using a stopwatch. Average and standard deviation of the time to complete the TUG test were calculated for each participant (each participant served as their own control in this pilot study).
Outcome measures
| Measure |
Habitual Prosthesis
n=3 Participants
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 2)
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
SIT With Assist-Knee (Settings 2)
Contralateral limb weight distribution during stand-to-sit at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
STAND With Assist-Knee (Settings 2)
Contralateral limb weight distribution during sit-to-stand at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
|---|---|---|---|---|
|
Timed Up and Go (TUG) Test
Participant A
|
7.1 seconds
Standard Deviation 0.5
|
—
|
—
|
—
|
|
Timed Up and Go (TUG) Test
Participant B
|
13.7 seconds
Standard Deviation 1.0
|
—
|
—
|
—
|
|
Timed Up and Go (TUG) Test
Participant C
|
12.3 seconds
Standard Deviation 0.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)Population: Each participant served as their own control in this analysis.
The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant completed the TUG test for three trials. Time was measured using a stopwatch. Average and standard deviation of the time to complete the TUG test were calculated for each participant (each participant served as their own control in this pilot study).
Outcome measures
| Measure |
Habitual Prosthesis
n=3 Participants
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 2)
n=3 Participants
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
SIT With Assist-Knee (Settings 2)
Contralateral limb weight distribution during stand-to-sit at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
STAND With Assist-Knee (Settings 2)
Contralateral limb weight distribution during sit-to-stand at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
|---|---|---|---|---|
|
Timed Up and Go (TUG) Test
Participant A
|
12.3 seconds
Standard Deviation 1.1
|
12.8 seconds
Standard Deviation 0.8
|
—
|
—
|
|
Timed Up and Go (TUG) Test
Participant B
|
25.0 seconds
Standard Deviation 3.0
|
22.0 seconds
Standard Deviation 1.4
|
—
|
—
|
|
Timed Up and Go (TUG) Test
Participant C
|
20.8 seconds
Standard Deviation 3.5
|
18.8 seconds
Standard Deviation 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Collection at baselinePopulation: Each participant served as their own control in this analysis.
The amount of time, measured in seconds, needed by the subject to complete the stand-to-sit transition. At least four trials of the stand-to-sit maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the stand-to-sit transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant being seated on a chair.
Outcome measures
| Measure |
Habitual Prosthesis
n=3 Participants
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 2)
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
SIT With Assist-Knee (Settings 2)
Contralateral limb weight distribution during stand-to-sit at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
STAND With Assist-Knee (Settings 2)
Contralateral limb weight distribution during sit-to-stand at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
|---|---|---|---|---|
|
Time to Complete Stand-to-Sit
Participant A
|
2.7 seconds
Standard Deviation 0.1
|
—
|
—
|
—
|
|
Time to Complete Stand-to-Sit
Participant B
|
4.1 seconds
Standard Deviation 1.0
|
—
|
—
|
—
|
|
Time to Complete Stand-to-Sit
Participant C
|
1.6 seconds
Standard Deviation 0.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)Population: Each participant served as their own control in this analysis.
The amount of time, measured in seconds, needed by the subject to complete the stand-to-sit transition. At least four trials of the stand-to-sit maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the stand-to-sit transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant being seated on a chair.
Outcome measures
| Measure |
Habitual Prosthesis
n=3 Participants
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 2)
n=3 Participants
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
SIT With Assist-Knee (Settings 2)
Contralateral limb weight distribution during stand-to-sit at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
STAND With Assist-Knee (Settings 2)
Contralateral limb weight distribution during sit-to-stand at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
|---|---|---|---|---|
|
Time to Complete Stand-to-Sit
Participant C
|
2.5 seconds
Standard Deviation 0.1
|
2.7 seconds
Standard Deviation 0.7
|
—
|
—
|
|
Time to Complete Stand-to-Sit
Participant A
|
4.4 seconds
Standard Deviation 0.4
|
3.3 seconds
Standard Deviation 0.4
|
—
|
—
|
|
Time to Complete Stand-to-Sit
Participant B
|
4.9 seconds
Standard Deviation 1.7
|
4.5 seconds
Standard Deviation 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Collection at baselinePopulation: Each participant served as their own control in this analysis.
The percentage of body weight on the contralateral limb was determined for both stand-to-sit and sit-to-stand transitions at 65 degrees knee flexion. A force plate under the contralateral limb recorded the amount of loading on the limb during the stand-to-sit and sit-to-stand transitions. The amount of contralateral limb loading at 65 degrees knee flexion was determined and divided by the participant's total loading due to overall body weight. This value was then converted to a percentage.
Outcome measures
| Measure |
Habitual Prosthesis
n=3 Participants
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 2)
n=3 Participants
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
SIT With Assist-Knee (Settings 2)
Contralateral limb weight distribution during stand-to-sit at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
STAND With Assist-Knee (Settings 2)
Contralateral limb weight distribution during sit-to-stand at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
|---|---|---|---|---|
|
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
Participant A
|
79.2 % body weight
Standard Deviation 2.8
|
85.9 % body weight
Standard Deviation 2.5
|
—
|
—
|
|
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
Participant B
|
61.8 % body weight
Standard Deviation 11.4
|
49.0 % body weight
Standard Deviation 2.3
|
—
|
—
|
|
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
Participant C
|
87.0 % body weight
Standard Deviation 3.6
|
95.8 % body weight
Standard Deviation 2.6
|
—
|
—
|
SECONDARY outcome
Timeframe: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)Population: Each participant served as their own control in this analysis.
The percentage of body weight on the contralateral limb was determined for both stand-to-sit and sit-to-stand transitions at 65 degrees knee flexion. A force plate under the contralateral limb recorded the amount of loading on the limb during the stand-to-sit and sit-to-stand transitions. The amount of contralateral limb loading at 65 degrees knee flexion was determined and divided by the participant's total loading due to overall body weight. This value was then converted to a percentage.
Outcome measures
| Measure |
Habitual Prosthesis
n=3 Participants
Participant's prescribed prosthesis
Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician.
|
Assist-Knee (Settings 2)
n=3 Participants
Experimental knee prosthesis
Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant.
|
SIT With Assist-Knee (Settings 2)
n=3 Participants
Contralateral limb weight distribution during stand-to-sit at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
STAND With Assist-Knee (Settings 2)
n=3 Participants
Contralateral limb weight distribution during sit-to-stand at 65 degrees knee flexion when using Assist-Knee (Settings 2).
|
|---|---|---|---|---|
|
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
Participant A
|
67.7 % body weight
Standard Deviation 7.5
|
82.0 % body weight
Standard Deviation 1.9
|
48.0 % body weight
Standard Deviation 9.4
|
83.5 % body weight
Standard Deviation 1.2
|
|
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
Participant B
|
23.5 % body weight
Standard Deviation 13.7
|
27.0 % body weight
Standard Deviation 6.9
|
19.4 % body weight
Standard Deviation 10.4
|
31.3 % body weight
Standard Deviation 2.3
|
|
Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
Participant C
|
67.0 % body weight
Standard Deviation 1.6
|
78.6 % body weight
Standard Deviation 4.5
|
63.4 % body weight
Standard Deviation 9.9
|
76.4 % body weight
Standard Deviation 3.2
|
Adverse Events
Study Participants
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