Caregiver-Assisted Limb Scanning for Amputees

Recruiting in Palo Alto (17 mi)

Overseen by Glenn K Klute, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Improper fit, Skin irritation, Osteoarthritis, others

No Placebo Group

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. ^{1 2 3 4 5}

Is the Caregiver-Assisted Limb Scanning for Amputees treatment generally safe for humans?

Research indicates that prosthetic sockets can cause discomfort, cysts, and sores, suggesting potential safety concerns related to skin issues. However, advancements in materials and fitting techniques aim to improve comfort and reduce these risks. ^{6 7 8 9 10}

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. ^{5 6 11 12 13}

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

It has been over a year since my amputation.

Have an eligible and available study helper

I have been using a prosthesis for at least 6 months.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Caregiver socket (Prosthetic Socket)
• Prosthetist socket (Prosthetic 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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

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

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References

1. France pubmed.ncbi.nlm.nih.gov

Using vacuum-assisted suspension to manage residual limb wounds in persons with transtibial amputation: a case series. [2022] Persons with amputation and residual limb wounds would benefit from the ability to continue wearing a prosthesis while healing. Sockets with vacuum-assisted suspension may reduce intra-socket motion and be less disruptive to wound healing. The purpose of this case series was to measure residual limb wound size over time in persons with transtibial amputation while using prostheses with vacuum-assisted suspension.

2. France pubmed.ncbi.nlm.nih.gov

The benefits of using a vacuum-assisted socket system to improve balance and gait in elderly transtibial amputees. [2022] Lower limb amputation leads to impaired balance, ambulation, and transfers. Proper fit of the prosthesis is a determining factor for successful ambulation. Vacuum-assisted socket systems extract air from the socket, which decreases pistoning and probability of soft-tissue injuries and increases proprioception and socket comfort.

3. England pubmed.ncbi.nlm.nih.gov

Adjustable prosthetic sockets: a systematic review of industrial and research design characteristics and their justifications. [2023] The prosthetic socket is a key component that influences prosthesis satisfaction, with a poorly fitting prosthetic socket linked to prosthesis abandonment and reduced community participation. This paper reviews adjustable socket designs, as they have the potential to improve prosthetic fit and comfort through accommodating residual limb volume fluctuations and alleviating undue socket pressure.

4. England pubmed.ncbi.nlm.nih.gov

Socket size adjustments in people with transtibial amputation: Effects on residual limb fluid volume and limb-socket distance. [2022] Small intermittent adjustments of socket size using adjustable sockets may be a means for people with transtibial amputation to better maintain residual limb fluid volume and limb position while using a prosthesis.

5. United States 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. [2021] Effective prosthetic socket design following lower limb amputation depends upon the accurate characterization of the shape of the residual limb as well as its volume and shape fluctuations.

6. France 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. [2022] Rehabilitation of a person with a non-functional arm and a trans-tibial amputation with a short stump with fragile skin, multiple scars and a limited knee function presents a considerable problem. The best prosthesis was considered to be one with a roll-on socket. Donning and cleaning of the socket however could not be done by the patient himself and it was therefore necessary to develop a device to permit the patient to perform these tasks independently. A case history is presented and the new device described.

7. France pubmed.ncbi.nlm.nih.gov

The comprehensive lower limb amputee socket survey: Reliability and validity of the persian version. [2021] The Comprehensive Lower limb Amputee Socket Survey (CLASS) is a self-reported measure developed to assess prosthetic socket fit in individuals with lower limb amputation.

8. Switzerland pubmed.ncbi.nlm.nih.gov

Mapping Lower-Limb Prosthesis Load Distributions Using a Low-Cost Pressure Measurement System. [2022] In the UK 55,000 people live with a major limb amputation. The prosthetic socket is problematic for users in relation to comfort and acceptance of the prosthesis; and is associated with the development of cysts and sores.

9. United States pubmed.ncbi.nlm.nih.gov

Measuring discomfort-An objective method for quantifying peak pressure discomfort and improved fit in adults with transtibial amputation. [2023] Prosthetic socket coupling with the residual limb should be comfortable without causing skin breakdown or excessive pressure. However, users report socket discomfort, and there is a scarcity of objective measurements available to assess this feeling of discomfort. Quantifying the specific pressure may enable clinicians and users to determine and improve comfort levels objectively.

10. United States pubmed.ncbi.nlm.nih.gov

Advanced prosthetic techniques for below knee amputations. [2022] Recent advances in the evaluation of the amputation stump, the materials that are available for prosthetic application, techniques of improving socket fit, and prosthetic finishings promise to dramatically improve amputee function. Precision casting techniques for providing optimal fit of the amputation stump using materials such as alginate are described. The advantages of transparent check sockets for fitting the complicated amputation stump are described. Advances in research that promise to provide more functional prosthetic feet and faster and more reliable socket molding are the use of CAD-CAM (computer aided design-computer aided manufacturing) and the use of gait analysis techniques to aid in the alignment of the prosthesis after socket fitting. Finishing techniques to provide a more natural appearing prosthesis are described. These advances will gradually spread to the entire prosthetic profession.

11. England pubmed.ncbi.nlm.nih.gov

The preformed socket and modular assembly for primary amputees. [2022] A method is described by which an artificial limb can be fitted as soon as an above-knee or below-knee amputation wound is healed, by using preformed sockets which enable the prosthetist to fit the limb within the hour. The method has been found safe, and better than other methods previously described to facilitate the early mobilisation and rehabilitation of the amputee.

12. United States pubmed.ncbi.nlm.nih.gov

Registering methodology for imaging and analysis of residual-limb shape after transtibial amputation. [2022] Successful prosthetic rehabilitation following lower-limb amputation depends upon a safe and comfortable socket-residual limb interface. Current practice predominantly uses a subjective, iterative process to establish socket shape, often requiring several visits to a prosthetist. This study proposes an objective methodology for residual-limb shape scanning and analysis by high-resolution, automated measurements. A three-dimensional printed "analog" residuum was scanned with three surface digitizers on 10 occasions. Accuracy was measured by the scan height error between repeat analog scans and the computer-aided design (CAD) geometry and the scan versus CAD volume. Subsequently, 20 male residuum casts from ambulatory individuals with transtibial amputation were scanned by two observers, and 10 were repeat-scanned by one observer. The shape files were aligned spatially and geometric measurements extracted. Repeatability was evaluated by intraclass correlation, Bland-Altman analysis of scan volumes, and pairwise root-mean-square error ranges of scan area and width profiles. Submillimeter accuracy was achieved when scanning the analog shape, and using male residuum casts the process was highly repeatable within and between observers. The technique provides clinical researchers and prosthetists the capability to establish their own quantitative, objective, multipatient data sets, providing an evidence base for training, long-term follow-up, and interpatient outcome comparison, for decision support in socket design.

13. France pubmed.ncbi.nlm.nih.gov

A qualitative study on stakeholder perceptions of digital prosthetic socket fabrication for transtibial amputations. [2022] Digital residual limb shape capture (three-dimensional [3D] scanning), computer-assisted design (CAD), and computer-assisted manufacturing with 3D printing technology show promise for a completely digital process of fabricating prosthetic sockets for patients with limb loss. The effectiveness and quality of digitally designed 3D-printed lower extremity prosthetic sockets is understudied, and there is lack of data on the patient and prosthetist experiences with this digital workflow.