Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.
This study will compare the use of Symphonie Aqua Digital System, which is a new way to create a socket for prosthetics, to the current method that is generally used to create sockets. The study will look at the differences in comfort and fit between the Symphonie Aqua Digital System and the current standard of care (SOC).
The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability & functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symphonie Aqua System - Non-Digital (Socket B) | Experimental | A digital weight bearing test socket where shape capturing is done in full weight bearing |
|
| Standard of Care (SoC) | Active Comparator | This is standard of care socket design where sockets are fabricated in non-weight bearing position |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symphonie Aqua Digital System mediated sh | Device | For socket fabrication, the shape capturing is done in full weight bearing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trans-Epidermal Water Loss (TEWL) | Differences between two systems and effects on Trans-Epidermal Water Loss (TEWL) will be measured by placing a non-invasive probe on the surface of the skin. Each measurement takes approximately 7-30 seconds each. The data is presented as g x m^-2xh^-1. Higher number indicates worse outcome. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Laser Speckle Imaging (LSI) | Differences between two systems and effects on blood flow will be measured using Laser Speckle Imaging (LSI) which is a non-invasive machine that uses light to capture the blood flow of participants residual limb. The blood flow (perfusion) data is expressed as perfusion units (PU) where PU is a relative, dimensionless measure of tissue blood flow or microvascular perfusion. Higher value indicates better perfusion (increase in blood flow). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sashwati Roy, PhD. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SoC (Socket A) First, Then Symphonie Aqua System - Non-Digital (Socket B) | Symphonie Aqua Digital System: A non-digital weight-bearing socket be used to create the check socket (temporary socket), which will be used to create a laminated final socket for home use and research outcomes. The check socket is temporarily used; whereas, the final socket is for long-term use. Soc Socket is a standard of care socket fabricated under non weight nearing position. The two groups are combined because all subjects started with SoC and then crossed over to Socket B. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Standard of Care Socket |
| |||||||||||||
| Symphonie Aqua System - Non-Digital |
|
This is a longitudinal study where all participants first participated in standard of care arm and later on crossed over to test arm
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Symphonie Aqua System - Non-Digital (Socket B) | Socket shape capturing done under full weight bearing conditions, this is the test socket. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Trans-Epidermal Water Loss (TEWL) | Differences between two systems and effects on Trans-Epidermal Water Loss (TEWL) will be measured by placing a non-invasive probe on the surface of the skin. Each measurement takes approximately 7-30 seconds each. The data is presented as g x m^-2xh^-1. Higher number indicates worse outcome. | Good quality TEWL data was available from n=5 in SoC and n=3 in DWB participants | Posted | Mean | Standard Deviation | g x m^-2xh^-1 | 6 weeks |
|
12-weeks
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 | Socket A - Standard of Care Socket | SoC Socket is a standard of care socket fabricated under non-weight-bearing position. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sashwati Roy | University of Pittsburgh | 412 624 0422 | sasr453@pitt.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 | Sep 6, 2022 | Aug 21, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 6, 2022 | Aug 29, 2023 | ICF_000.pdf |
Not provided
Not provided
Not provided
This is a crossover study where participants perform baseline visit in standard of care and then switched to DWB arm.
Not provided
Not provided
Not provided
Not provided
| 6-weeks |
| In-socket Pressure | Measurements of socket pressure will be evaluated using in-socket sensors, which are positioned into the socket and function to detect the amount of residual load (pressure) that is placed on the limb. | 6-weeks |
| Mobility (6MWT) | 6-minute walking test (6MWT); Subject will walk for 6 consecutive minutes and, once the 6 minutes has elapsed, the distance covered will be measured. | 6-weeks |
| Balance During Ambulation (TUG) | Timed up and go test; In the timed up-and-go outcome, the patient rises from a seated position, walks three meters at a self-selected speed, turns around, and returns to the chair where they reseat themselves. | 6-weeks |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Symphonie Aqua Digital System: A non-digital weight-bearing socket will be used to create the check socket (temporary socket), which will be used to create a laminated final socket for home use and research outcomes. The check socket will be temporarily used, whereas the final socket is for long-term use.
|
|
| Secondary | Laser Speckle Imaging (LSI) | Differences between two systems and effects on blood flow will be measured using Laser Speckle Imaging (LSI) which is a non-invasive machine that uses light to capture the blood flow of participants residual limb. The blood flow (perfusion) data is expressed as perfusion units (PU) where PU is a relative, dimensionless measure of tissue blood flow or microvascular perfusion. Higher value indicates better perfusion (increase in blood flow). | Posted | Mean | Standard Deviation | PU | 6-weeks |
|
|
|
| Secondary | In-socket Pressure | Measurements of socket pressure will be evaluated using in-socket sensors, which are positioned into the socket and function to detect the amount of residual load (pressure) that is placed on the limb. | Posted | Mean | Standard Deviation | kPa | 6-weeks |
|
|
|
| Secondary | Mobility (6MWT) | 6-minute walking test (6MWT); Subject will walk for 6 consecutive minutes and, once the 6 minutes has elapsed, the distance covered will be measured. | Posted | Mean | Standard Deviation | meters | 6-weeks |
|
|
|
| Secondary | Balance During Ambulation (TUG) | Timed up and go test; In the timed up-and-go outcome, the patient rises from a seated position, walks three meters at a self-selected speed, turns around, and returns to the chair where they reseat themselves. | Posted | Mean | Standard Deviation | Seconds | 6-weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Socket B - Symphonie Aqua Digital System | Symphonie Aqua Digital System: A non-digital weight-bearing socket will be used to create the check socket (temporary socket), which will be used to create a laminated final socket for home use and research outcomes. The check socket will be temporarily used, whereas the final socket is for long-term use. | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided