Caregiver-Assisted Limb Scanning for Amputees
Trial Summary
What is the purpose of this trial?
When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Veterans who live in rural communities far from VA Medical Centers or alternative prosthetic clinics. This research seeks to determine if one of the in-person visits traditionally needed to obtain a well-fitting prosthesis can be performed remotely with the assistance of a helper. The investigators seek to discover if an untrained individual (a helper) can wield inexpensive, easy to use, digital technology to capture the shape of a residual limb to see if it can be used to fabricate a prosthetic socket that fits at least as well as one fabricated by a prosthetist using traditional, hand casting methods in the clinic. The expected result of this research is an evidence-based prosthetic fabrication process that reduces Veteran travel burden while providing a prosthesis that fits at least as well as the current standard-of-care. The upshot is a clear improvement in prosthetic provision for Veterans, particularly for those who live in rural communities. To make this determination, the investigators will perform a between-subject experiment with two specific aims. To determine differences in goodness of fit between the two study sockets, the investigators will use both patient reported outcomes, and measurements of the pressure applied to the distal end of the residual limb. Specific Aim 1: Determine if patient reported outcomes, by subjects wearing a prosthetic socket whose shape was captured with study helper assistance, are at least as good as those reported by subjects wearing a socket whose shape was captured by a prosthetist. The investigators propose to recruit Veterans with a below knee amputation and their study helpers to participate in a human subject experiment. Participants will be randomly assigned and fit with either a prosthesis made with study helper assistance and digital methods, or one made wholly by a prosthetist using traditional methods. Patient reported outcome metrics will be collected while the subject is still wearing their as-prescribed socket at the beginning of the study (baseline), and again after wearing the study prosthesis for two weeks. Specific Aim 2: Determine if distal end residual limb pressure, measured from a group of individuals fit with a prosthetic socket whose shape was captured with study helper assistance using digital methods, are no worse than those measured from a group of individuals fit with a prosthetic socket whose shape was captured by a prosthetist using traditional methods. Concurrent with the human subject procedures briefly described above, the investigators propose to fabricate duplicates (copies) of the two prosthetic sockets used by each subject in Specific Aim 1. A novel sensor will be embedded in these duplicate sockets which can measure the pressure applied to the distal end of the residual limb. Measurements of distal end residual limb pressure while standing and walking for both the as-prescribed and study sockets will be collected at the beginning of the study (baseline), and again after two weeks. The data from the investigators' experiments will be used to determine if residual limb shape capture by a helper using digital technologies can be used to make prosthetic sockets that fit at least as well as those made by a prosthetist using traditional, hand casting techniques. One third of all Veterans live in rural communities far from VA Medical Centers. When Veterans with a lower limb amputation need a new prosthetic socket, attending in-person clinical visits can be a challenge. If the hypotheses are supported, this research will provide evidence to support the use of digital technology as part of clinical practice, enabling a remote, study helper enabled alternative to one of the in-person clinical visits needed to fabricate a well-fitting prosthesis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Caregiver socket, Prosthetic Socket, Artificial Limb Socket, Prosthetist socket, Prosthetic socket, Artificial limb socket, Residual limb socket?
Research shows that vacuum-assisted socket systems can improve balance and walking ability in elderly amputees by reducing movement within the socket and increasing comfort. Adjustable sockets can also enhance fit and comfort by accommodating changes in the limb's size, which is crucial for prosthesis satisfaction and continued use.12345
Is the Caregiver-Assisted Limb Scanning for Amputees treatment generally safe for humans?
How is the Caregiver-Assisted Limb Scanning treatment for amputees different from other treatments?
The Caregiver-Assisted Limb Scanning treatment is unique because it involves caregivers in the process of scanning the residual limb, potentially improving the fit and comfort of the prosthetic socket. This approach contrasts with traditional methods that rely heavily on subjective assessments by prosthetists and often require multiple visits to achieve a proper fit.56111213
Research Team
Glenn K Klute, PhD
Principal Investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Eligibility Criteria
This trial is for Veterans with a below-knee amputation who've used a prosthesis for at least 6 months, wear it over 4 hours daily, and can walk on a treadmill. They must be one-year post-amputation and have someone to help them with the study.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants' baseline data is collected while wearing their as-prescribed socket
Treatment
Participants are fitted with either a prosthesis made with study helper assistance using digital methods or one made by a prosthetist using traditional methods
Follow-up
Participants are monitored for socket comfort, stability, suspension, and distal end residual limb pressure
Treatment Details
Interventions
- Caregiver socket (Prosthetic Socket)
- Prosthetist socket (Prosthetic Socket)
Caregiver socket is already approved in Canada for the following indications:
- Lower limb amputation
- Upper limb amputation
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Dr. Grant Huang
VA Office of Research and Development
Acting Chief Research and Development Officer
PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences
Dr. Erica M. Scavella
VA Office of Research and Development
Chief Medical Officer since 2022
MD from University of Massachusetts School of Medicine