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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002319 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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Ensuring a well fitting prosthetic socket is a major challenge in the care of people with amputation. Poor fit causes pain, skin issues, reduced mobility, and lower satisfaction, affecting daily activity and quality of life. Current prosthetic socket fit assessment relies on prosthesis user feedback, prosthetist experience or intrusive equipment. The investigators have developed a non-invasive prototype socket fit testing system that attaches externally to the end of any prosthetic socket and uses two air cylinders to apply resistance and track motion. During testing, socket motion is mapped to a cursor on a screen. Participants perform a test where they move their leg and socket to randomly presented targets. Movement duration and accuracy provide measures of how well the socket and leg move together. This pilot study will assess feasibility and validity of the socket fit testing system performance for above-the-knee prosthesis users.
One of the biggest challenges in prosthetic care is making sure the prosthetic socket fits well with the residual limb. This "socket fit" is critical for both comfort and function. When the socket doesn't fit properly, it can cause pain, skin problems, and reduced performance. Poor socket fit can also lower a person's satisfaction with their prosthesis, limit their ability to perform daily activities, and negatively impact quality of life.
Current methods of assessing socket fit are qualitative-based on patient feedback or comfort surveys-or they use expensive and/or invasive equipment. These methods don't provide precise measurements of how well the socket and residual limb are working together, and some require altering the socket to insert instrumentation inside.
To address these limitations, the investigators are testing a non-invasive prototype device for measuring socket fit. This device attaches externally to the end of any prosthetic socket and uses two long air cylinders connected to sensors (potentiometers and load cells) and a TV monitor. With it, prosthesis users can perform different leg movements against resistance while wearing their socket.
The standardized test protocol requires participants to perform hip movements in all directions (flexion, extension, abduction, and adduction). The movement range is scaled to each person's height and hip motion, so the test has a consistent level of difficulty across individuals. The main hypothesis is that a better socket fit will allow more accurate movements, measured by how long the movements take and how much error is present. The overarching hypothesis is that better socket fit will result in more accurate movements, as measured by movement duration and error.
In this study, the investigators will evaluate the prototype device in adults with unilateral above-the-knee (transfemoral amputation, TFA). The investigators plan to recruit 18 participants with TFA:
The investigators will also compare these movement metrics with participants' self-reported Socket Comfort Scores. Showing that the test protocol is feasible to implement, the device operates as intended, and differences in coupling can be detected will give the investigators pilot data to support larger clinical trials.
Specific Aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with transfemoral amputation | Other | Prosthetic socket fit testing system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosthetic socket fit testing system | Device | Prosthetic socket fit testing system to assess socket-limb coupling using movement error and duration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Repeatability | Assess repeatability of performing the prosthetic socket fit test in terms of movement time and accuracy. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Practice effects | Assess how many trials are required for steady state performing the prosthetic socket fit test in terms of movement time and accuracy. | Day 1 |
| Known groups validity | Assess difference in measurement time and accuracy between loose and tight prosthetic socket fit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefania Fatone, PhD, BPO(Hons) | Contact | 206-685-7918 | sfaton@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stefania Fatone, PhD, BPO(Hons) | University of Washington | Principal Investigator |
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| Day 1 |
| Convergent validity | Assess correlation between movement time and accuracy with socket comfort score for difference between tight and loose fitting prosthetic sockets. | Day 1 |