Lower Limb Amputation Below Knee (Injury)
Conditions
Keywords
Prosthetic Socket, Amputee, Pin Lock Prosthetic Socket
Brief summary
The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.
Detailed description
Limb fluid volume changes that can occur in the residual limb of a lower-limb amputee can result in changes in socket fit that lead to discomfort, skin injuries, and reduced mobility. It is known that limb fluid volume fluctuations can be reduced for some people by intermittently removing (doffing) the socket throughout the day. It is believed that partially doffing the socket may have a similar benefit, and could be made more convenient thereby promoting easier compliance for prosthetic users. The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation. The technology enables partial doffing through the release and relock of a socket panel and the prosthetic pin used to hold the limb in place. The expected outcomes are an enhanced understanding of how socket adjustments after activity facilitate limb fluid volume recovery, subsequent fluid retention, and improved socket fit.
Interventions
DEVICERelease/Relock Socket - In Lab
The participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, in lab, following a structured protocol. Tests will determine if the order of the re-lock mechanisms influences changes in limb volume.
DEVICERelease/Relock Socket - Out of Lab
The participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine if the order of the re-lock mechanisms changes participant experience.
DEVICERelease/Relock Socket & Control
The participants will operate the test socket in one of two test conditions: (1) release/relock mechanisms enabled and (2) release/relock mechanisms disabled. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine how the novel release/relock mechanisms compare against traditional socket release methods.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Washington
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Had trans-tibial amputation at least 18 months prior to enrollment * Regularly wear a definitive prosthesis for at least 7 hours per week * Have a residual limb length of at least 9 cm * K2 or higher MFCL * Able to walk continuously with a prosthesis for at least 2 minutes at a time * Sit, stand, and negotiate a step of 5.0 cm Participants involved remotely will have to meet the following inclusion criteria: * Have a spare prosthesis * No cognitive issues * Good hand dexterity and strength (not frail) * Capable of communication over a video Zoom conference call.
Exclusion criteria
* Current presence of skin breakdown * Unable to satisfy inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Limb Volume | Change from baseline period (no release/relock) to test period (release/relock), 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 release/relock 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. |
| Prosthesis Evaluation Questionnaire (PEQ) | Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments. | Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each question on the PEQ can receive a score form 0 to 100, with higher scores indicating greater satisfaction. |
| PROMIS-Fatigue | Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments. | Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each PROMIS-Fatigue question asks participants to rank on a scale from 1 to 5 (categorical options), with higher scores indicating greater level of fatigue. |
| Socket Comfort Score (SCS) | Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments. | Participants will be asked to rank their comfort while using the test socket out of lab in various test configurations. The SCS ranges from 0 to 10 (categorical), with higher scores indicating greater level of comfort. |
Countries
United States
Contacts
Primary ContactJoan E Sanders, PhD
Outcome results
None listed