Prosthetic Smart Socket Technology to Improve Patient Interaction, Usability, Comfort, Fit, and Function.
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/22/2019 |
| Start Date: | March 29, 2018 |
| End Date: | July 2019 |
| Contact: | Jason Highsmith, PhD |
| Email: | michael.highsmith@va.gov |
| Phone: | 813-625-5406 |
A common problem for the intermediate preparatory stage of prosthetic rehabilitation is
distal pressure, due to commonly compromised sensation and lack of understanding how to
address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin
breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent
this common problem among rehabilitating amputees, smart socket technology has been developed
to better identify problems that may occur. The Smart Socket Technology including Prompting
(SST+P) in this pre-clinical project proposal provides a step activity monitor and senses
distal pressure, which is novel to the technology. When excessive pressure is sensed on the
residual limb, it will send a signal to the user's smart phone to make an adjustment. This
prompting improves patient interaction and may prevent problems as a result of common volume
fluctuation and compromised sensation. The purpose of this clinical trial is to determine if
the ALPS iForce smart socket technology with prompting (SST+P) will improve patient
interaction, usability, comfort, fit, function and health economy outcomes compared with the
standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces
distal pressure, due to commonly compromised sensation and lack of understanding how to
address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin
breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent
this common problem among rehabilitating amputees, smart socket technology has been developed
to better identify problems that may occur. The Smart Socket Technology including Prompting
(SST+P) in this pre-clinical project proposal provides a step activity monitor and senses
distal pressure, which is novel to the technology. When excessive pressure is sensed on the
residual limb, it will send a signal to the user's smart phone to make an adjustment. This
prompting improves patient interaction and may prevent problems as a result of common volume
fluctuation and compromised sensation. The purpose of this clinical trial is to determine if
the ALPS iForce smart socket technology with prompting (SST+P) will improve patient
interaction, usability, comfort, fit, function and health economy outcomes compared with the
standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces
Limb loss requires prosthetic use. Prostheses usually consist of 2 components: 1) a soft
interface to protect the skin and underlying musculoskeletal tissue and 2) a structural
interface to enable attachment of prosthetic components to the human body. The interface
connects the patient's body to the prosthetic components and thus ground during gait. The
interface has 2 purposes: 1) to distribute weight-bearing forces throughout the entire
residual limb (RL) and 2) to suspend the prosthesis during swing phase and unweighting. The
interface assists in distributing vertical loads during weight bearing to minimize focal
loading on pressure intolerant tissues. The interface also suspends prosthetic components to
the RL in swing phase and other periods of unweighting.
Many amputees experience RL complications and decreased mobility resulting from the inability
to detect excess pressure or a lack of distal contact with newly fit and poorly fit
interfaces. A smart socket technology interface could benefit every new prosthetic patient by
prompting the user of a compromised socket fit prior to inhibiting functional use and safety.
Further, the smart socket technology interface may ultimately prevent other health
complications and improve patient interaction, usability, comfort, fit and function. The ALPS
iForce most economically measures these variables more comprehensively than any other known
single device. Therefore the smart socket interface technology chosen for this proposal is
the ALPs iForce. The iForce tracks pressure over time and indicates to the user when positive
or negative distal pressure exists by providing volume management suggestions (i.e. sock-ply
adjustments). The user interacts with data measured sent wirelessly to an application on a
smart phone (Android/iOS/Windows), handheld device, or PC. Suggestions may include removal or
application of prosthetic socks over the RL, or other appropriate volume management
strategies, to improve fit and comfort. Early warning to possible skin irritation and
breakdown may lead to a healthier limb.
interface to protect the skin and underlying musculoskeletal tissue and 2) a structural
interface to enable attachment of prosthetic components to the human body. The interface
connects the patient's body to the prosthetic components and thus ground during gait. The
interface has 2 purposes: 1) to distribute weight-bearing forces throughout the entire
residual limb (RL) and 2) to suspend the prosthesis during swing phase and unweighting. The
interface assists in distributing vertical loads during weight bearing to minimize focal
loading on pressure intolerant tissues. The interface also suspends prosthetic components to
the RL in swing phase and other periods of unweighting.
Many amputees experience RL complications and decreased mobility resulting from the inability
to detect excess pressure or a lack of distal contact with newly fit and poorly fit
interfaces. A smart socket technology interface could benefit every new prosthetic patient by
prompting the user of a compromised socket fit prior to inhibiting functional use and safety.
Further, the smart socket technology interface may ultimately prevent other health
complications and improve patient interaction, usability, comfort, fit and function. The ALPS
iForce most economically measures these variables more comprehensively than any other known
single device. Therefore the smart socket interface technology chosen for this proposal is
the ALPs iForce. The iForce tracks pressure over time and indicates to the user when positive
or negative distal pressure exists by providing volume management suggestions (i.e. sock-ply
adjustments). The user interacts with data measured sent wirelessly to an application on a
smart phone (Android/iOS/Windows), handheld device, or PC. Suggestions may include removal or
application of prosthetic socks over the RL, or other appropriate volume management
strategies, to improve fit and comfort. Early warning to possible skin irritation and
breakdown may lead to a healthier limb.
Inclusion Criteria:
1. Unilateral transtibial amputation
2. Unilateral revision or reconstruction of transtibial amputation
3. Candidate for intermediate stage (i.e. preparatory) socket fitting
4. Male or female, of any ethnicity
5. 18-60 yrs of age (i.e. active military age)
6. 100-275 lbs.
Exclusion Criteria:
1. Body weight <100 or >275 lbs
2. Does not speak English or Spanish
3. Any other level of amputation than unilateral TTA
We found this trial at
1
site
4202 E Fowler Ave
Tampa, Florida 33620
Tampa, Florida 33620
(813) 974-2011
Phone: 813-974-3806
University of South Florida The University of South Florida is a high-impact, global research university...
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