Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance

NCT05884203 | Recruiting

• 3 other identifiers: F4276-RI01RX0042761676634
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lower Extremity Amputation

Keywords

lower limb amputation; transtibial amputation; below knee amputation; prosthetic socket; prosthesis

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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).

  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).

  After a two week acclimation period where the participant wears the study prosthesis in the home, community, and work environments.

Study Arms (2)

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).

Device: Caregiver socket

Prosthetist socket

EXPERIMENTAL

Participants will wear a prosthetic socket whose shape was captured by a prosthetist using traditional, hand casting methods.

Device: Prosthetist socket

Interventions

Caregiver socket DEVICE

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.

Caregiver socket

Prosthetist socket DEVICE

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.

Prosthetist socket

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

RECRUITING

Study Officials

• Glenn K Klute, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenn K Klute, PhD

CONTACT

(206) 764-2991; Glenn.Klute@va.gov

Elise B Campbell, MS BFA BA

CONTACT

(206) 277-6792; elise.campbell@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants: Subjects will be blinded. Each subject will participate in both residual limb shape capture methods during the first study visit (order randomly assigned), but only one study socket (either the study helper assisted socket with digital methods, or the prosthetist made socket with traditional methods) will be used for outcomes testing (randomly assigned and blinded to the participant). Care Provider: The prosthetist will fabricate the prosthetist socket using traditional methods, thereby knowing study socket and participant randomization. However, the investigators will apply apply a fabric cover to the sockets (both sensorized as-prescribed and study sockets) during visits 3 and 4. This method blinds the prosthetist during the distal end residual limb pressure measurements. Outcomes Assessor. The study staff collecting patient reported outcomes will also be blinded, as they will not know which socket the participant received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within six months of publication of final study findings.
• Access Criteria: Open access through PubMed Central, SimTK, PhysioNet, or other similar open-source data repository websites.

Locations

US (1)