Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this research is to create a prosthetic system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.
People with lower limb amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb health problems including skin breakdown and injury to deeper tissues. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day.
The objective of this research is to develop and test an automatically-adjusting prosthetic socket system for prosthesis users. The system integrates with a range of adjustable socket technologies, including those that are commercially available. The system allows small size adjustments for both tightening and loosening the socket. In early aims of the study, the prosthesis will be adjusted manually, but can be controlled remotely, eliminating the need to remove the prosthesis or bend down to make adjustments. The system will later be enhanced to automatically change the fit of an adjustable socket at the appropriate times, without distracting the user. We hypothesize that this system will help to maintain consistent limb fluid volume while the prosthesis user is wearing the socket and that socket fit will be improved. The system functions by continuously collecting measurements from sensors within the socket and uses small motors to control adjustable panels in the socket wall.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 2 - Adjustable Socket - Researcher Controls | Experimental | An adjustable socket is tested where researchers control the adjustments. This arm focuses on socket size adjustments while walking. |
|
| Aim 3 - Adjustable Socket - Participant Controls | Experimental | An adjustable socket is tested where the study participant controls the adjustments. This arm focuses on socket size adjustments while walking. |
|
| Aim 4 - Adjustable Socket - Automatic Controls | Experimental | 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. |
|
| Aim 6A - Release/Recovery - Researcher Controls | Experimental | 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. |
|
| Aim 6B - Release/Recovery - Participant Controls | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustable socket | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Limb Volume | 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. | 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. |
| Change in Limb Movement | 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. | 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. |
| Number of Participants With Increase in Limb Fluid Volume After Panel Pull | 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. | 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. |
| Integral of Absolute Error to Maintain Set Point |
| Measure | Description | Time Frame |
|---|---|---|
| Adjustable Socket Mode Preference | Participants tested the adjustable prosthesis in their home environment in one of three adjustment configurations:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joan E Sanders, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Bioengineering | Seattle | Washington | 98195 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Limb Volume | 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. | Change in Limb Volume was monitored only for Arms 2, 6A, 6B, 8 and 9. | Posted | Count of Participants | Participants | 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. |
|
Each participant was monitored over the course of their involvement in each Arm's tests, which ranged from same day observations to up to two weeks of out-of-lab testing.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Ballesteros | University of Washington | 206-221-5873 | danieb25@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2023 | Apr 28, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Aim 8 - Panel Pull During Resting | Experimental | 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. |
|
| Aim 9 - Panel Pull During Ambulation | Experimental | 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. |
|
| Aim 10 - Adjustable Socket Out of Lab Testing | Experimental | 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. |
|
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).
| Over 30 minutes of controlled use of the auto-adjusting socket |
| After 3 weeks of use, where each mode was tested for about 1 week |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Limb Movement | 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. | Change in Limb Movement was only measured for Arm 3. | Posted | Median | Full Range | Millimeters | 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. |
|
|
|
| Primary | Change in Limb Volume | 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. | 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. | Posted | Number | participants | 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. |
|
|
|
| Primary | Change in Limb Volume | 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. | Change in Limb Volume was monitored only for Arms 2, 6A, 6B, 8 and 9. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Number of Participants With Increase in Limb Fluid Volume After Panel Pull | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Integral of Absolute Error to Maintain Set Point | 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). | Posted | Median | Full Range | Millimeters | Over 30 minutes of controlled use of the auto-adjusting socket |
|
|
|
| Secondary | Adjustable Socket Mode Preference | Participants tested the adjustable prosthesis in their home environment in one of three adjustment configurations:
| Posted | Count of Participants | Participants | After 3 weeks of use, where each mode was tested for about 1 week |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Stress-Sensing Liner | An adjustable socket is tested in addition to a prosthetic liner with embedded stress sensors to measure mechanical stresses as the socket is adjusted. 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG004 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG005 | 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG006 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG007 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG008 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided