Adjustable Prosthetic Sockets for Limb Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests adjustable prosthetic sockets for Veterans with lower limb amputations. The goal is to evaluate how these sockets fit during different activities and how they can be adjusted for comfort. Researchers will measure the pressure inside the socket during various tasks to understand its effects. Veterans who have used a prosthesis for at least a year, wear it for over four hours a day, and can walk on a treadmill might be suitable candidates for this trial. As an unphased trial, it offers Veterans the chance to contribute to advancements in prosthetic technology and enhance comfort for future users.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing prosthetic sockets, so it's unlikely that medications would be affected, but you should confirm with the trial organizers.
What prior data suggests that adjustable prosthetic sockets are safe for Veterans?
Research has shown that adjustable prosthetic sockets are generally safe for users. One study found these sockets to be as safe as traditional ones, with participants reporting no falls or skin issues such as sores or irritation. Another study revealed that users preferred the fit and comfort of adjustable sockets, rating them higher for comfort and overall satisfaction.
These findings suggest that users tolerate adjustable prosthetic sockets well. Although pressure on the limb may vary with different activities, the overall feedback remains positive. This indicates they are a good option for those needing a socket that can adjust to fit better over time.12345Why are researchers excited about this trial?
Researchers are excited about adjustable prosthetic sockets because they offer a customizable fit for individuals with limb loss. Unlike traditional prosthetic sockets that require frequent refitting as limb size and shape change, these adjustable sockets can be easily modified by the user to ensure comfort and stability throughout the day. This innovation is expected to enhance user comfort, improve mobility, and reduce the time and cost associated with prosthetic adjustments.
What evidence suggests that adjustable prosthetic sockets are effective for improving prosthetic fit?
Studies have shown that adjustable prosthetic sockets, which participants in this trial will use, can greatly enhance comfort and movement for people with lower limb amputations. In one study, participants reported feeling 19% to 37% more comfortable and performing better with adjustable sockets compared to standard ones. Another study found that these sockets improved comfort scores by 3.13 points and overall satisfaction by 4.57 points. These sockets adapt to the shape of the residual limb over time, ensuring a better and longer-lasting fit. This flexibility reduces the need for frequent replacements, making daily activities more comfortable and manageable.23678
Who Is on the Research Team?
Glenn K Klute, PhD
Principal Investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Are You a Good Fit for This Trial?
This trial is for Veterans who are at least one year post-lower limb amputation, can walk on a treadmill, wear their prosthesis for over 4 hours daily, and have a modular prosthesis with a four-bolt socket attachment. It's specifically for those with unilateral transtibial amputations.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Acclimation
Participants wear an adjustable prosthetic socket in the home, community, and work environments to acclimate
Laboratory Testing
Participants perform various activities in the laboratory while pressure measurements are taken
Follow-up
Participants are monitored for safety and effectiveness after laboratory testing
What Are the Treatments Tested in This Trial?
Interventions
- Adjustable Prosthetic Socket
Trial Overview
The study tests adjustable prosthetic sockets designed to maintain a good fit over time. Participants will use these sockets in various activities while pressure on the residual limb is measured to assess comfort and the need for adjustments.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will wear an adjustable prosthetic socket.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Citations
COMPARATIVE EFFECTIVENESS OF AN ADJUSTABLE ...
In the baseline volume condition, the adjustable socket improved subjective and performance measures 19% to 37% over SOC, whereas the two-minute walk test ...
The Impact of Transfemoral Adjustable-Volume Sockets on ...
Adjustable-volume sockets offer an alternative to conventional laminated sockets that can positively affect comfort, perceived mobility, and ...
Study Details | NCT07397169 | Adjustable Prosthetic Sockets
The purpose of this research is to discover how Veterans use adjustable prosthetic sockets by measuring the pressure applied to the residual ...
ADJUSTABLE-VOLUME PROSTHETIC INTERFACES
Meta-analysis showed an increase of 3.13 in fit comfort, measured with the socket comfort score(SCS), and 4.57 in overall satisfaction, measured ...
An adaptive prosthetic socket for people with transtibial ...
We suspect the SFM decrease is from the residual limb sinking deeper into the socket—most participants reached a more stable depth in about 15 ...
Adjustable prosthetic sockets: a systematic review of industrial ...
Poorly fitting sockets often lead to discomfort due to skin breakdown and tissue damage, which can have major long-term consequences. Skin ...
A PROSPECTIVE ASSESSMENT OF AN ADJUSTABLE ... - PMC
Conclusions: The IFIT transtibial prosthetic system appears to be safe in this short term trial. It compared favorably to subjects' conventional prostheses ...
A Prospective Assessment of an Adjustable, Immediate Fit ...
This new subischial socket is feasible and safe for use in persons with transfemoral limb loss. None of the participants reported a fall, skin breakdown, or ...
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