NCT05884203 · VA Office of Research and Development
Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Caregiver socket
A prosthetic socket whose shape was captured by a study helper using digital methods (i.e., 3D scanner). The digital file describing the socket dimensions will be sent to a central fabrication facility where the prosthetic socket will be manufactured.
DEVICE
Prosthetist socket
A prosthetic socket whose shape was captured by a prosthetist using traditional, hand casting methods. The hand cast will be plaster filled to create a positive model. A prosthetist socket will be fabricated over the positive model using thermoplastic materials.
Primary outcome measures
Socket Comfort Score (SCS)
Time frame: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Participants rate the comfort of their socket on an 11-point scale where 0 and 10 represent the most uncomfortable and the most comfortable socket imaginable, respectively.
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Stability Score
Time frame: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Participants rate their stability when wearing their prosthesis on a 4-point scale where 1 indicates they strongly disagree and 4 indicates they strongly agree that they feel stable and balanced in their socket when they are sitting, standing, walking, or ascending/descending stairs. The Stability score is reported as a percentage of awarded score / total possible score.
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Suspension Score
Time frame: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Participants rate their security with their prosthetic suspension on a 4-point scale where 1 indicates they strongly disagree and 4 indicates they strongly agree that they feel secure in their socket with no excessive movement when they are sitting, standing, walking, or ascending/descending stairs. The Suspension score is reported as a percentage of awarded score / total possible score.
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Comfort Score
Time frame: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Participants rate their comfort when wearing their prosthesis on a 4-point scale where 1 indicates they strongly disagree and 4 indicates they strongly agree that they feel comfortable in their socket when they are sitting, standing, walking, or ascending/descending stairs. The Comfort score is reported as a percentage of awarded score / total possible score.
Standing distal end residual pressure
Time frame: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant stands for 60 seconds. The first and last fifteen seconds of the standing pressure data (60 second trial) will be truncated and the mean pressure will be calculated from the middle 30 seconds of each trial (3 repeated trials).
Walking distal end residual limb pressure
Time frame: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks on a treadmill at their self-selected speed for 60 seconds. The first and last fifteen seconds of the walking pressure data (60 second trial) will be truncated and the mean pressure will be calculated from the middle 30 seconds of each trial (3 repeated trials).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Unilateral transtibial amputation
- Been fit with a prosthesis and used it for at least 6 months
- Wear the prosthesis for 4 or more hours on average per day
- Has a prosthesis that bolts to the bottom of the socket
- Be at least one-year post-amputation
- Able to walk on a treadmill
- Have an eligible and available study helper
Exclusion criteria
- Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources
- Current skin irritation or injury on residual limb
- Osteoarthritis, injury, or pain that interferes with walking ability
- Currently incarcerated
- Inadequate cognitive function or language proficiency to consent to participate
Where
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations