Lower Extremity AmputationNCT05884203
Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance
A study testing Caregiver socket and Prosthetist socket in people with Lower Extremity Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lower Extremity Amputation
- What is being tested?
- Caregiver socket and Prosthetist socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Pregnant
- Inadequate cognitive function or language proficiency to consent to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
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.
Read more
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.
Read the detailed description
The objective of this research is to determine if advances in technology, namely digital methods to capture residual limb shape, can meet the well-fitting prosthetic socket standard-of-care with the added benefits of improved access and service delivery. The current standard of care for prosthetic provision requires multiple, in-person clinical visits between the Veteran and their prosthetist. Separate visits for residual limb shape capture, check socket fitting, and definitive socket delivery are required every time a new socket is needed. For Veterans who live in rural communities far from VA facilities, the challenges associated with attending these clinical visits can be a significant burden. This research seeks to determine if the residual limb shape capture visit can be performed remotely with the assistance of a study helper using digital methods.
Of paramount concern when providing a prosthesis to a Veteran with a lower limb amputation is obtaining a good fit. Prosthetic sockets that fit poorly are either worn sparingly or not at all. Obtaining a good fit is a process. Veterans know it when they wear a well-fitting prosthesis and prosthetists know it when they see it (lack of reactive hyperemia). Patient reported outcomes play an important role whereby the prosthetist solicits feedback from the patient about how the check socket feels and the location of any perceived discomfort. This informal approach is infrequently supplemented with qualitative survey instruments. Reducing or eliminating excessive distal end pressure is also essential as the distal end tissues of the residual limb can rarely support body weight loads without discomfort or injury. However, no instrument to directly measure distal end residual limb pressures is commercially available.
The investigators propose to determine if a prosthetic socket, whose shape is captured remotely by a study helper using a digital scanner, fits at least as well as a prosthetic socket whose shape is captured in-person by a prosthetist using traditional hand casting methods. If it does, then rural Veterans with a helper could forgo a clinical visit. To make this determination, the investigators propose to perform a between-subject experiment with two specific aims.
Specific Aim 1: Determine if patient reported outcomes, reported by a group of individuals fit with a prosthetic socket whose shape was captured with study helper assistance using digital methods, are at least as good as those reported by a different group of individuals fit with a prosthetic socket whose shape was captured by a prosthetist using traditional methods. The investigators propose to recruit ambulatory Veterans with unilateral transtibial amputation (n=20) and their study helpers (n=20) to participate in a between-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 (baseline) at the beginning of the study, 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. In addition to the human subject procedures of Specific Aim 1, the investigators further propose to fabricate two duplicate prosthetic sockets for each subject: one duplicate of the subject's as-prescribed socket and one duplicate of the study socket randomly assigned to the subject in Specific Aim 1. Embedded in the distal end of these duplicate sockets will be a novel pressure sensor. Distal end residual limb pressure while standing and walking will be measured while the subject is still wearing their as-prescribed socket (baseline), and again after wearing the study prosthesis for two weeks.
The proposed research will discover if it is possible to forgo one of the clinical visits needed to fabricate a well-fitting prosthesis. It is the investigators' hope that this research will advance the use of technology in the provisioning of prostheses, particularly to Veterans who live in rural communities far from VA Medical Centers or alternative service providers.
- Conditions
- Lower Extremity Amputation
- Being tested
- Caregiver socket, Prosthetist socket
- Keywords
- lower limb amputation, transtibial amputation, below knee amputation, prosthetic socket, prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver socketDevice
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.
Prosthetist socketDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver socket | Experimental | Participants will wear a prosthetic socket whose shape was captured by a study helper using digital methods (i.e., a 3D scanner). Receives: Device: Caregiver socket |
| Prosthetist socket | Experimental | Participants will wear a prosthetic socket whose shape was captured by a prosthetist using traditional, hand casting methods. Receives: Device: Prosthetist socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socket Comfort Score (SCS)
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.
Measured: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Stability Score
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.
Measured: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Suspension Score
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.
Measured: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Comfort Score
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.
Measured: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Standing distal end residual pressure
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).
Measured: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Walking distal end residual limb pressure
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).
Measured: After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jul 2023
- Primary completion10 Jul 2026
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The shape of the participants' residual limb will be captured with both study helper assistance and digital methods, and also by a prosthetist using traditional methods. However, only one study socket, randomly assigned, will be manufactured and used for outcomes testing.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Glenn K Klute, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884203
- Sponsor's protocol ID
- F4276-R
- Other IDs
- I01RX004276, 1676634
- Status last verified
- Jul 2026
- First submitted
- 22 May 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A de-identified, anonymized dataset will be created and available to the public via a VA authorized website. Where possible, the investigators will work with manuscript publishers to link the final study data sets as an appendix to published manuscripts. By providing de-identified datasets in open file formats (e.g., .txt, .xls, .mat) along with clearly documented instructions for processing, interested recipients will be able to reproduce and build on the same techniques which the investigators will outline in our publications. A public release identifier for each subject's data (e.g., CGS\_001, CGS\_002) will be created and randomly paired with de-identified study data. Data will consist of subject demographics, test, and questionnaire results. There will be no tractable way to re-match these data to the subject. Our methods will be verified by the VAPSHCS Privacy Officer.
Publications
Ardianuari S, Berge JS, Klute GK. Amputee gait performance symmetry may be affected by how prosthetic socket shape is captured: A preliminary investigation. Prosthet Orthot Int. 2026 Jul 31. doi: 10.1097/PXR.0000000000000564. Online ahead of print.
PubMed 42532655
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance
- ClinicalTrials.gov ID
- NCT05884203
- Acronym / sponsor ID
- F4276-R
- Conditions
- Lower Extremity Amputation
- Keywords
- lower limb amputation, transtibial amputation, below knee amputation, prosthetic socket, prosthesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this research is to determine if advances in technology, namely digital methods to capture residual limb shape, can meet the well-fitting prosthetic socket standard-of-care with the added benefits of improved access and service delivery. The current standard of care for prosthetic provision requires multiple, in-person clinical visits between the Veteran and their prosthetist. Separate visits for residual limb shape capture, check socket fitting, and definitive socket delivery are required every time a new socket is needed. For Veterans who live in rural communities far from VA facilities, the challenges associated with attending these clinical visits can be a significant burden. This research seeks to determine if the residual limb shape capture visit can be performed remotely with the assistance of a study helper using digital methods.
Of paramount concern when providing a prosthesis to a Veteran with a lower limb amputation is obtaining a good fit. Prosthetic sockets that fit poorly are either worn sparingly or not at all. Obtaining a good fit is a process. Veterans know it when they wear a well-fitting prosthesis and prosthetists know it when they see it (lack of reactive hyperemia). Patient reported outcomes play an important role whereby the prosthetist solicits feedback from the patient about how the check socket feels and the location of any perceived discomfort. This informal approach is infrequently supplemented with qualitative survey instruments. Reducing or eliminating excessive distal end pressure is also essential as the distal end tissues of the residual limb can rarely support body weight loads without discomfort or injury. However, no instrument to directly measure distal end residual limb pressures is commercially available.
The investigators propose to determine if a prosthetic socket, whose shape is captured remotely by a study helper using a digital scanner, fits at least as well as a prosthetic socket whose shape is captured in-person by a prosthetist using traditional hand casting methods. If it does, then rural Veterans with a helper could forgo a clinical visit. To make this determination, the investigators propose to perform a between-subject experiment with two specific aims.
Specific Aim 1: Determine if patient reported outcomes, reported by a group of individuals fit with a prosthetic socket whose shape was captured with study helper assistance using digital methods, are at least as good as those reported by a different group of individuals fit with a prosthetic socket whose shape was captured by a prosthetist using traditional methods. The investigators propose to recruit ambulatory Veterans with unilateral transtibial amputation (n=20) and their study helpers (n=20) to participate in a between-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 (baseline) at the beginning of the study, 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. In addition to the human subject procedures of Specific Aim 1, the investigators further propose to fabricate two duplicate prosthetic sockets for each subject: one duplicate of the subject's as-prescribed socket and one duplicate of the study socket randomly assigned to the subject in Specific Aim 1. Embedded in the distal end of these duplicate sockets will be a novel pressure sensor. Distal end residual limb pressure while standing and walking will be measured while the subject is still wearing their as-prescribed socket (baseline), and again after wearing the study prosthesis for two weeks.
The proposed research will discover if it is possible to forgo one of the clinical visits needed to fabricate a well-fitting prosthesis. It is the investigators' hope that this research will advance the use of technology in the provisioning of prostheses, particularly to Veterans who live in rural communities far from VA Medical Centers or alternative service providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The shape of the participants' residual limb will be captured with both study helper assistance and digital methods, and also by a prosthetist using traditional methods. However, only one study socket, randomly assigned, will be manufactured and used for outcomes testing.
| Arm | Type | Receives |
|---|---|---|
| Caregiver socket | Experimental | Device: Caregiver socketParticipants will wear a prosthetic socket whose shape was captured by a study helper using digital methods (i.e., a 3D scanner). |
| Prosthetist socket | Experimental | Device: Prosthetist socketParticipants will wear a prosthetic socket whose shape was captured by a prosthetist using traditional, hand casting methods. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver socketA 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 | Caregiver socket |
| Prosthetist socketA 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. | Device | Prosthetist socket |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 42532655Ardianuari S, Berge JS, Klute GK. Amputee gait performance symmetry may be affected by how prosthetic socket shape is captured: A preliminary investigation. Prosthet Orthot Int. 2026 Jul 31. doi: 10.1097/PXR.0000000000000564. Online ahead of print.
- Individual participant dataSharing planned: Yes. Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A de-identified, anonymized dataset will be created and available to the public via a VA authorized website. Where possible, the investigators will work with manuscript publishers to link the final study data sets as an appendix to published manuscripts. By providing de-identified datasets in open file formats (e.g., .txt, .xls, .mat) along with clearly documented instructions for processing, interested recipients will be able to reproduce and build on the same techniques which the investigators will outline in our publications. A public release identifier for each subject's data (e.g., CGS_001, CGS_002) will be created and randomly paired with de-identified study data. Data will consist of subject demographics, test, and questionnaire results. There will be no tractable way to re-match these data to the subject. Our methods will be verified by the VAPSHCS Privacy Officer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn K Klute, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver socket and Prosthetist socket in people with Lower Extremity Amputation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.