Trial Outcomes & Findings for Auto Control of Volume Management for Limb Loss (NCT NCT03550118)
NCT ID: NCT03550118
Last Updated: 2023-05-03
Results Overview
Clinically acceptable socket volume error as measured by an automatically adjusting prosthetic socket attempting to maintain a set socket volume set point, based on sensed distance (measured in mm).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Over 30 minutes of controlled use of the auto-adjusting socket
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 3 - Adjustable Socket - Participant Controls
An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 4 - Adjustable Socket - Automatic Controls
An adjustable socket is tested where a control system is used to automatically control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 6A - Release/Recovery - Researcher Controls
An adjustable socket is tested where researchers control the adjustments. This arm focuses on a socket release and recovery mechanism that allows for full or partial doffing of the socket while seated.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 6B - Release/Recovery - Participant Controls
An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on a socket release and recovery mechanism that allows for full or partial doffing of the socket while seated.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 9 - Panel Pull During Ambulation
Extending from the Aim #8 results, we sought to determine in Aim #9 if "vacuum-like" action during ambulation facilitated limb fluid volume recovery and retention. Vacuum-like action was achieved by quickly pulling the panels and liner (liner attached to panels) radially outward during late stance phase and then moving them back to their original position during early swing.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 10 - Adjustable Socket Out of Lab Testing
Participants took the investigational device home in one of three test modes. In the first mode, the panels were in a "locked" flush position, similar to their traditional prosthesis. Participants were not able to adjust the panels in this first mode. The second mode allowed participants to manually make panel adjustments, incrementally enlarging or tightening the panels radially. Lastly, the third mode implemented the automated controller developed in the previous aims. Participants were still able to make manual adjustments to the panel positions but during walks adjustments would also occur automatically. Each mode was tested for a minimum of 1 week.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
13
|
12
|
13
|
7
|
14
|
12
|
18
|
|
Overall Study
COMPLETED
|
10
|
12
|
10
|
12
|
6
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
2
|
1
|
1
|
2
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auto Control of Volume Management for Limb Loss
Baseline characteristics by cohort
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
n=15 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 3 - Adjustable Socket - Participant Controls
n=13 Participants
An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 4 - Adjustable Socket - Automatic Controls
n=12 Participants
An adjustable socket is tested where a control system is used to automatically control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 6A - Release/Recovery - Researcher Controls
n=13 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on a socket release and recovery mechanism that allows for full or partial doffing of the socket while seated.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 6B - Release/Recovery - Participant Controls
n=7 Participants
An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on a socket release and recovery mechanism that allows for full or partial doffing of the socket while seated.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
n=14 Participants
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 9 - Panel Pull During Ambulation
n=12 Participants
Extending from the Aim #8 results, we sought to determine in Aim #9 if "vacuum-like" action during ambulation facilitated limb fluid volume recovery and retention. Vacuum-like action was achieved by quickly pulling the panels and liner (liner attached to panels) radially outward during late stance phase and then moving them back to their original position during early swing.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 10 - Adjustable Socket Out of Lab Testing
n=18 Participants
Participants took the investigational device home in one of three test modes. In the first mode, the panels were in a "locked" flush position, similar to their traditional prosthesis. Participants were not able to adjust the panels in this first mode. The second mode allowed participants to manually make panel adjustments, incrementally enlarging or tightening the panels radially. Lastly, the third mode implemented the automated controller developed in the previous aims. Participants were still able to make manual adjustments to the panel positions but during walks adjustments would also occur automatically. Each mode was tested for a minimum of 1 week.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
87 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
91 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
94 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
84 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
12 participants
n=5 Participants
|
13 participants
n=4 Participants
|
7 participants
n=21 Participants
|
14 participants
n=8 Participants
|
12 participants
n=8 Participants
|
18 participants
n=24 Participants
|
104 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.Population: Change in Limb Volume was monitored only for Arms 2, 6A, 6B, 8 and 9.
Limb volume fluctuations will be measured in real-time as socket adjustment strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Outcome measures
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
n=10 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
|---|---|---|
|
Change in Limb Volume
Experienced limb volume change
|
8 Participants
|
—
|
|
Change in Limb Volume
Maintained limb volume
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.Population: Change in Limb Movement was only measured for Arm 3.
Limb movement within the socket will be measured as socket adjustment strategies are tested. It will be used as an indicator of how well the socket is fitting (loose, tight, etc). The measurement will be made using an inductance sensor that is placed in the socket which measures the displacement of a sensor patch on the prosthetic liner. Specifically, the change in limb movement will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Outcome measures
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
n=12 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
|---|---|---|
|
Change in Limb Movement
Sensed Distance, Total Change in Response to Enlargement of Socket Size
|
0.01 Millimeters
Interval -0.13 to 0.11
|
—
|
|
Change in Limb Movement
Sensed Distance, Total Change in Response to Reduction of Socket Size
|
-0.03 Millimeters
Interval -0.17 to 0.07
|
—
|
PRIMARY outcome
Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.Population: Change in Limb Volume was monitored only for Arms 2, 6A, 6B, 8 and 9. Participants were grouped according to their responses to the intervention. The groups "immediate limb volume increase" and "decrease in rate of limb volume loss" presented below are not mutually exclusive. Some participants that experienced immediate limb volume increase were also seen to exhibit a decrease in the rate of limb volume loss.
Limb volume fluctuations will be measured in real-time as socket adjustment strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Outcome measures
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
n=12 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
|---|---|---|
|
Change in Limb Volume
Immediate Limb Volume Increase
|
9 participants
|
—
|
|
Change in Limb Volume
Decrease in rate of limb volume loss
|
7 participants
|
—
|
PRIMARY outcome
Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.Population: Change in Limb Volume was monitored only for Arms 2, 6A, 6B, 8 and 9.
Limb volume fluctuations will be measured in real-time as socket adjustment strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Outcome measures
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
n=6 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
n=12 Participants
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
|---|---|---|
|
Change in Limb Volume
Gain in Limb Fluid Volume
|
3 Participants
|
12 Participants
|
|
Change in Limb Volume
Loss of Limb Fluid Volume
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.Limb volume fluctuations will be measured in real-time as socket adjustment strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Outcome measures
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
n=12 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
|---|---|---|
|
Number of Participants With Increase in Limb Fluid Volume After Panel Pull
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: Over 30 minutes of controlled use of the auto-adjusting socketClinically acceptable socket volume error as measured by an automatically adjusting prosthetic socket attempting to maintain a set socket volume set point, based on sensed distance (measured in mm).
Outcome measures
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
n=10 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
|---|---|---|
|
Integral of Absolute Error to Maintain Set Point
|
0.003 Millimeters
Interval 0.001 to 0.005
|
—
|
SECONDARY outcome
Timeframe: After 3 weeks of use, where each mode was tested for about 1 weekParticipants tested the adjustable prosthesis in their home environment in one of three adjustment configurations: 1. "locked" where panels were kept in position and did not move, similar to their own prosthesis 2. "manual" where panels were able to be adjusted inward or outward radially, by the participant via a phone app 3. "automatic" where panels adjusted inward or outward radially as when the participant walked for a sufficiently continuous amount of time. Participants were also able to manual adjust panels as needed in this mode as well.
Outcome measures
| Measure |
Aim 2 - Adjustable Socket - Researcher Controls
n=10 Participants
An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
Aim 8 - Panel Pull During Resting
The purpose of Aim #8 was to determine if vacuum-like action ("panel pull") during resting between periods of activity facilitated limb fluid volume recovery and retention in transtibial prosthesis users. Liner attached to panels.
Adjustable socket: The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
|
|---|---|---|
|
Adjustable Socket Mode Preference
Preferred Automatic Mode
|
5 Participants
|
—
|
|
Adjustable Socket Mode Preference
Preferred Manual Mode
|
5 Participants
|
—
|
|
Adjustable Socket Mode Preference
Preferred Locked Mode
|
0 Participants
|
—
|
Adverse Events
Aim 2 - Adjustable Socket - Researcher Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 3 - Adjustable Socket - Participant Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 4 - Adjustable Socket - Automatic Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stress-Sensing Liner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 6A - Release/Recovery - Researcher Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 6B - Release/Recovery - Participant Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 8 - Panel Pull During Resting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 9 - Panel Pull During Ambulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 10 - Adjustable Socket Out of Lab Testing
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