Amputation, Prosthesis User, Residual Limbs
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESymphonie Aqua Digital System mediated sh
For socket fabrication, the shape capturing is done in full weight bearing.
Sponsors
United States Department of Defense
Indiana University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a crossover study where participants perform baseline visit in standard of care and then switched to DWB arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 18 and above * Unilateral trans-tibial amputees * Ambulate at a K3 level or higher * At least 3 months post-amputation per physician discretion * Trans-tibial limb length greater than 4.5 inches in length * Able to follow directions and independently give informed consent * Must be able to ambulate without assistance
Exclusion criteria
* Age \< 18 years * Conditions that prevent wearing a prosthetic socket * Soc Socket made with weight bearing system * Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol * Women who are pregnant or who plan to become pregnant in the near future * Weight \> 280 lbs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans-Epidermal Water Loss (TEWL) | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laser Speckle Imaging (LSI) | 6-weeks | 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). |
| In-socket Pressure | 6-weeks | 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. |
| Mobility (6MWT) | 6-weeks | 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. |
| Balance During Ambulation (TUG) | 6-weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Symphonie Aqua System - Non-Digital (Socket B) Socket shape capturing done under full weight bearing conditions, this is the test socket. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Symphonie Aqua System - Non-Digital | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Symphonie Aqua System - Non-Digital (Socket B) |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 0 / 10 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
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.
Time frame: 6 weeks
Population: Good quality TEWL data was available from n=5 in SoC and n=3 in DWB participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Socket A - Standard of Care Socket | Trans-Epidermal Water Loss (TEWL) | 22.9 g x m^-2xh^-1 | Standard Deviation 9.46 |
| Socket B - Symphonie Aqua Digital System | Trans-Epidermal Water Loss (TEWL) | 14.7 g x m^-2xh^-1 | Standard Deviation 5.11 |
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.
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Socket A - Standard of Care Socket | Balance During Ambulation (TUG) | 9.3 Seconds | Standard Deviation 2.3 |
| Socket B - Symphonie Aqua Digital System | Balance During Ambulation (TUG) | 9.6 Seconds | Standard Deviation 2 |
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.
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Socket A - Standard of Care Socket | In-socket Pressure | 1.93 kPa | Standard Deviation 1.36 |
| Socket B - Symphonie Aqua Digital System | In-socket Pressure | 0.91 kPa | Standard Deviation 0.79 |
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).
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Socket A - Standard of Care Socket | Laser Speckle Imaging (LSI) | 4.8 PU | Standard Deviation 3.4 |
| Socket B - Symphonie Aqua Digital System | Laser Speckle Imaging (LSI) | 4.1 PU | Standard Deviation 2.8 |
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.
Time frame: 6-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Socket A - Standard of Care Socket | Mobility (6MWT) | 376 meters | Standard Deviation 57 |
| Socket B - Symphonie Aqua Digital System | Mobility (6MWT) | 364 meters | Standard Deviation 47 |