Caregiver-Assisted Limb Scanning for Amputees

Overseen By Elise B Campbell, MS BFA BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Improper fit, Skin irritation, Osteoarthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a helper using digital tools can fit a prosthetic leg as effectively as a professional using traditional methods. It focuses on assisting Veterans with lower leg amputations who live far from medical centers. The goal is to simplify the process of obtaining a new prosthetic socket (also known as a caregiver socket) and reduce travel stress. Veterans who have used a prosthesis for at least six months and have a helper available might be suitable candidates. As an unphased trial, this study offers Veterans the opportunity to contribute to innovative solutions that may enhance accessibility and convenience in prosthetic care.

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 prior data suggests that this limb scanning method is safe for amputees?

Research has shown that prosthetic sockets, whether made using digital methods by a caregiver or traditional methods by a prosthetist, can sometimes cause safety issues like discomfort or skin problems. For sockets made by caregivers using digital methods, studies have found that while these methods can work well, issues with fit and comfort may still arise. Improperly fitting sockets can lead to painful skin problems such as cysts or pressure sores.

Similarly, sockets made by prosthetists using traditional methods can also cause pain if they don't fit well or if movement occurs between the limb and the socket. Both types of sockets aim to be safe, but discomfort or skin issues remain a risk. Discussing these potential risks with the trial team is advisable to understand how they might affect participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about caregiver-assisted limb scanning for amputees because it could revolutionize how prosthetic sockets are made. Unlike traditional sockets, which rely on a prosthetist's hand casting methods, this new approach uses digital 3D scanning conducted by a caregiver. This digital method is not only potentially more convenient and accessible but may also lead to a more personalized fit for the wearer. By empowering caregivers with this technology, the process of creating a prosthetic socket could become more efficient and adaptable to the wearer's unique needs.

What evidence suggests that this trial's methods for prosthetic socket fitting could be effective?

This trial will compare two methods for creating prosthetic sockets. Participants in one arm will use a "Caregiver socket," where a study helper employs digital methods, such as a 3D scanner, to capture the shape. Research has shown that caregiver assistance in limb scanning for prosthetic sockets is promising. Specifically, early results from a study found that using a vacuum-assisted system improved balance and walking distance, suggesting that prosthetic sockets made with digital methods can lead to better outcomes.

In the other arm, participants will use a "Prosthetist socket," where a prosthetist applies traditional hand casting methods. Studies have shown that expert input is crucial for a comfortable fit in traditional prosthetic sockets. Both methods aim to provide a well-fitting prosthesis, but the caregiver-assisted option might reduce travel and stress for Veterans. ^{1 5 6 7 8}

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 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

It has been over a year since my amputation.

Have an eligible and available study helper

I can walk on a treadmill.

Exclusion Criteria

I have skin issues on my amputated limb.

My current prosthesis does not fit well and cannot be adjusted.

I have joint pain or an injury that affects my ability to walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants' baseline data is collected while wearing their as-prescribed socket

1 week

1 visit (in-person)

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

2 weeks

1 visit (in-person or remote)

Follow-up

Participants are monitored for socket comfort, stability, suspension, and distal end residual limb pressure

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver socket
• Prosthetist socket

Trial Overview The study compares two ways of making prosthetic sockets: one using digital technology by an untrained helper, and the other by a professional prosthetist using traditional methods. The fit and comfort reported by patients as well as pressure measurements will determine if the new method is effective.

How Is the Trial Designed?

Group I: Prosthetist socket Experimental Treatment 1 Intervention

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

Group II: Caregiver socket Experimental Treatment 1 Intervention

Participants will wear a prosthetic socket whose shape was captured by a study helper using digital methods (i.e., a 3D scanner).

Caregiver socket is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Prosthetic Socket for:

• Lower limb amputation
• Upper limb amputation

Approved in European Union as Prosthetic Socket for:

• Lower limb amputation
• Upper limb amputation

Approved in Canada as Prosthetic Socket for:

• Lower limb amputation
• Upper limb amputation

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 16 unilateral transtibial dysvascular amputees aged around 65, the use of vacuum-assisted socket systems significantly improved balance, gait, and transfer abilities after just 4 weeks, as evidenced by various performance tests.

The vacuum-assisted socket system led to measurable improvements, such as a 7.5-point increase in the Berg Balance Scale score and a 32.85-meter increase in the 6-Min Walk Test, highlighting its effectiveness in enhancing mobility and reducing fall risk in older amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of using a vacuum-assisted socket system to improve balance and gait in elderly transtibial amputees. Samitier, CB., Guirao, L., Costea, M., et al.[2022]

Adjustable prosthetic sockets have the potential to significantly improve fit and comfort for users, which is crucial for preventing prosthesis abandonment and enhancing community participation, as evidenced by a review of 50 literature articles and 63 patents.

Despite the promise of adjustable sockets, many designs lack adequate safety features and the rationale for their comfort improvements is often unclear, highlighting a need for better collaboration between researchers and industry to address these gaps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustable prosthetic sockets: a systematic review of industrial and research design characteristics and their justifications. Baldock, M., Pickard, N., Prince, M., et al.[2023]

In a study of 16 participants with transtibial amputation, adjustments to prosthetic sockets led to a significant reduction in peak pressure, which correlated with improved comfort scores, indicating that pressure management can enhance user comfort.

The majority of participants (15 out of 16) experienced resolution of wounds, redness, and pain after socket adjustments, demonstrating the effectiveness of using a pressure sensor to guide modifications for better prosthetic fit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring discomfort-An objective method for quantifying peak pressure discomfort and improved fit in adults with transtibial amputation. Binedell, T., Ghazali, MFB., Wong, C., et al.[2023]

In a study involving 10 participants with transtibial amputation, adjustable sockets allowed for real-time modifications that maintained limb fluid volume within a narrow range of -0.7% to +0.9% during walking, indicating effective management of limb fit.

Participants accepted socket sizes that varied from -5% to +5% of their neutral volume, demonstrating that small adjustments can significantly impact limb fluid volume and the distance between the limb and socket, suggesting potential for improved comfort and function in prosthetic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socket size adjustments in people with transtibial amputation: Effects on residual limb fluid volume and limb-socket distance. McLean, JB., Redd, CB., Larsen, BG., et al.[2022]

The Persian version of the Comprehensive Lower limb Amputee Socket Survey (CLASS) has demonstrated very good internal consistency (Cronbach's alpha between 0.86 and 0.92) and good to excellent test-retest reliability (intra-class correlation coefficients from 0.73 to 0.97) in a study involving 124 participants with unilateral lower limb amputation.

The CLASS scores showed significant correlations with satisfaction levels measured by the Trinity Amputation and Prosthesis Experience Scales (TAPES), confirming its validity as a reliable tool for assessing prosthetic socket fit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comprehensive lower limb amputee socket survey: Reliability and validity of the persian version. Rouhani, N., Esfandiari, E., Babaee, T., et al.[2021]

In a case series involving six subjects with transtibial amputation, the use of vacuum-assisted suspension sockets allowed for continued prosthetic use while healing residual limb wounds, with an average wound closure time of 177.6 days.

The initial average wound size was 2.17 cm², and the findings indicate that these well-fitting sockets did not hinder the healing process, suggesting a potential new approach to managing residual limb wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using vacuum-assisted suspension to manage residual limb wounds in persons with transtibial amputation: a case series. Hoskins, RD., Sutton, EE., Kinor, D., et al.[2022]

A new device was developed to help a patient with a non-functional arm and a trans-tibial amputation independently don and clean a roll-on socket prosthesis, addressing significant rehabilitation challenges.

The case highlights the importance of creating assistive technologies that empower patients with limited mobility and fragile skin to manage their own prosthetic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A device to facilitate donning and cleaning of a roll-on socket in a trans-tibial amputee with a non-functional arm. Smeets, RJ., Olsman, J.[2022]

A prototype system using pressure-sensitive sensors and an inertial measurement unit successfully assessed in-socket loading profiles in four transtibial amputees during walking, providing valuable data on how pressure is distributed within prosthetic sockets.

The sensors accurately reflected expected loading patterns, which can help improve the design and fit of prosthetic sockets, potentially reducing discomfort and the risk of sores for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping Lower-Limb Prosthesis Load Distributions Using a Low-Cost Pressure Measurement System. Hopkins, MO., Turner, S., Vaidyanathan, R., et al.[2022]

Recent advancements in prosthetic technology, including precision casting and transparent check sockets, significantly enhance the fit and function of prosthetic limbs for amputees.

The integration of CAD-CAM technology and gait analysis improves the alignment and customization of prosthetics, leading to better overall performance and comfort for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced prosthetic techniques for below knee amputations. Staats, TB.[2022]

The new method allows for the fitting of artificial limbs within an hour after the amputation wound has healed, using preformed sockets, which is a significant improvement over previous methods.

This approach has been found to be safe and enhances early mobilization and rehabilitation for amputees, leading to better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The preformed socket and modular assembly for primary amputees. McDougall, A., Emmerson, A.[2022]

This study introduces an objective method for scanning and analyzing the shape of residual limbs in lower-limb amputees, achieving submillimeter accuracy, which can improve the fitting of prosthetic sockets.

The scanning technique demonstrated high repeatability, allowing prosthetists to create reliable, quantitative data sets for better decision-making in socket design and enhancing the rehabilitation process for amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Registering methodology for imaging and analysis of residual-limb shape after transtibial amputation. Dickinson, AS., Steer, JW., Woods, CJ., et al.[2022]

Patients and prosthetists expressed enthusiasm for using a completely digital process for fabricating prosthetic sockets, indicating a positive reception towards 3D scanning, CAD, and 3D printing technologies.

While there are perceived advantages of digital fabrication over traditional methods, concerns regarding the durability, safety, and aesthetics of 3D-printed sockets were raised, highlighting the need for further research to optimize this technology in prosthetic practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study on stakeholder perceptions of digital prosthetic socket fabrication for transtibial amputations. Mayo, AL., Gould, S., Cimino, SR., et al.[2022]

A novel multi-camera system and open-source 3D digital image correlation (3D-DIC) toolbox were developed to accurately measure and analyze the shape and deformation of residual limbs in transtibial amputees, capturing high-resolution data during various activities like knee flexion and muscle contractions.

This low-cost framework allows for detailed evaluation of limb shape changes and mechanical properties, which can significantly improve the design of prosthetic sockets and other wearable technologies that interact with the skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Framework for Measuring the Time-Varying Shape and Full-Field Deformation of Residual Limbs Using 3-D Digital Image Correlation. Solav, D., Moerman, KM., Jaeger, AM., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-lower-extremity-amputation-6-2023-74558

Caregiver-Assisted Limb Scanning for Amputees The vacuum-assisted socket system led to measurable improvements, such as a 7.5-point increase in the Berg Balance Scale score and a 32.85-meter increase in the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39304077/

A Clinical Comparison With Traditional Plaster Cast Socket ... The study demonstrates promising results for using an AI algorithm in prosthetic socket design, but long-term effectiveness and refinement for improved comfort ...

3. mdpi.com mdpi.com/2076-3417/14/16/7274

Report on Prosthetic Fitting, Mobility, and Overall ... The aim of the study was to analyze mobility, pain, supply of assistive devices, and additional therapies received after major limb amputations.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04212299

Transfemoral Socket Design and Muscle Function The objective of this pilot research project is to evaluate the effect of prosthetic socket design on amputated limb hip muscle strength and endurance in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12383791/

A Narrative Review of Prosthesis Design Decision Making ... Prosthetic sockets affect a prosthesis user's satisfaction, comfort, prosthesis use, mobility, and function [7, 16, 29, 34, 74, 75]. Socket designs vary in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11892707/

Screening and patient selection for bone-anchored limb ... When problems with traditional socket-mounted prostheses continue to affect a lower limb amputee's functional outcomes and overall quality of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590109524000545

Creation of a Limb Loss and Preservation Registry for ... A national Limb Loss and Preservation Registry (LLPR) designed to collect, standardize, and report patient outcomes data on limb loss and limb difference in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397974/

The Impact of Limited Prosthetic Socket Documentation In this article, the concerns, issues and consequences arising from lack of upper and lower limb socket documentation are discussed from a researcher ...