K-Socket-Harness for Amputees

(KSH Trial)

Overseen By Elizabeth B Toth, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Open sores, Heterotopic ossification, others

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

Compensation: Varies

Number of Visits: 2

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve and test a new type of prosthetic arm socket and harness system, the K-Socket-Harness, designed to be more comfortable and functional than traditional options. The research will focus on Veterans with transradial (below the elbow) arm amputations, comparing the new system's performance to current prosthetics. Participants will help refine the design and test its comfort and usability in everyday tasks. Veterans with a unilateral transradial amputation who have used a prosthetic arm for at least a year may be a good fit for this study. As an unphased trial, this study offers Veterans the chance to contribute to innovative prosthetic development and potentially enhance their own prosthetic experience.

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 the K-Socket-Harness system is safe for amputees?

Research shows that many people using traditional prostheses are dissatisfied with their comfort. More than half report pain when using these devices. The K-Socket-Harness (KSH) system aims to enhance comfort by incorporating materials similar to those in athletic shoes, potentially making it more comfortable and easier to wear.

Although specific safety data for the KSH system is not yet available, its design prioritizes comfort and ease of use. The study aims to test these features with veterans who have below-elbow amputations. As this is an early research project, safety information is still being gathered.

In summary, the KSH is designed with user comfort in mind. The study will evaluate its effectiveness and comfort, but more data is needed to fully assess its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the K-Socket-Harness (KSH) for amputees because it aims to enhance comfort and usability compared to traditional prosthetic systems. Unlike standard prostheses, which can be cumbersome and uncomfortable, the KSH is designed to improve load-bearing capacity and user satisfaction, as well as reduce the time needed to put on and take off the device. Additionally, the KSH system is evaluated for its potential to improve the range of motion and overall quality of life for users, making it a promising advancement for veterans and others needing more functional and easier-to-use prosthetics.

What evidence suggests that the K-Socket-Harness is effective for transradial arm amputees?

Research shows that many people using prosthetic limbs are dissatisfied with their current devices. More than half find their prosthetics uncomfortable and painful. The K-Socket-Harness (KSH), which participants in this trial will test, aims to solve these issues with a design inspired by athletic shoes, potentially offering a better fit and more comfort. Studies have found that prosthetics with adjustable sockets can fit and feel better by adapting to the user's limb. This adaptability could lead to greater satisfaction, as users might experience fewer problems with discomfort and usability. ^{1 6 7 8 9}

Who Is on the Research Team?

Rory A Cooper, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

This trial is for Veterans with a single below-elbow amputation who have used any prosthetic arm for at least one year, or five years for early phases. They must have a residual limb of at least 4 inches long but short enough to allow 1.5 inches clearance from a fitted wrist device.

Inclusion Criteria

My residual limb is at least 4 inches long.

I have used a prosthetic for at least 5 years.

I have used a prosthetic for at least 1 year.

Exclusion Criteria

My residual limb is shorter than 4 inches.

I don't have open wounds or conditions that stop me from wearing a prosthetic.

My residual limb allows for more than 1.5 inches clearance from a fitted wrist.

Timeline for a Trial Participant

Phase 1: Design and Development

Five experienced Veterans with transradial arm amputations are recruited to provide guidance and assist with the design and development of the KSH system.

4-6 weeks

Multiple visits (in-person and virtual)

Phase 2: Testing and Assessment

Testing and assessment of the design and process validation with the five Veteran upper transradial arm amputees.

8 weeks

Weekly visits (in-person)

Phase 3: Broader Evaluation

An additional 20 Veterans with transradial arm amputations are recruited and fit with the KSH system to undergo a series of evaluative tests.

12 weeks

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main phases of the trial.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• K-Socket-Harness

Trial Overview The study tests the K-Socket-Harness (KSH) system, which uses advanced shoe technology for better fit and function in prosthetic arms. It involves design collaboration with Veterans, digital fitting tools, and evaluation through tasks assessing comfort and functionality.

How Is the Trial Designed?

Group I: Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de Experimental Treatment 1 Intervention

The investigators will perform several functional tests of the both the KSH system and the standard of care prosthesis: tensile static load bearing capacity before failure, test rowing ergometer 10-minute test before failure measured using strokes per minute, power in Watts, distance in meters, maximal force, and time before failure, range of motion in flexion/extension, and donning/doffing time.

Group II: Verify functionality of the KSH system through testing with end-users. Experimental Treatment 1 Intervention

The investigators will use System Usability Scale (SUS) to assess high usability with setup and operation of the device. The investigators will assess Comfort Scores (SCS), evaluate weight and correlate it with user satisfaction. The investigators will report selection outcome between new design and current design. The investigators will asses 1) functional status, (2) health- related quality of life, and (3) satisfaction with services and (4) device scores through the Orthotics and Prosthetics User Survey (OPUS).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Stumpworx LLC

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study involving 20 unilateral transtibial amputees, the vacuum-assisted socket suspension system (VASS) resulted in significantly less residual limb pistoning compared to the pin suspension system, indicating a better fit in terms of socket stability.

However, participants were less active and preferred the pin suspension system, taking about half as many steps while using the VASS, suggesting that while VASS may improve fit, it may not enhance overall mobility or user satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume. Klute, GK., Berge, JS., Biggs, W., et al.[2015]

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]

A new low-cost, portable, wireless sensor system has been developed to measure pressure at the socket-limb interface during prosthetic fitting, which is crucial for safety and fit.

In clinical tests with three transtibial prosthesis users, this new sensor system showed comparable accuracy to a commercial system, indicating its potential for effective use in prosthetic socket manufacture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Custom Interface Pressure Measurement System to Improve Fitting of Transtibial Prosthetic Check Sockets. Armitage, L., Cho, K., Sariyildiz, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9636812/

A review of user needs to drive the development of lower ... According to the literature, 57% of prosthesis users are dissatisfied with the comfort of their prostheses, and over 50% report pain during use ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6181602/

Prosthesis satisfaction in lower limb amputees Forty percent to 60% of amputee patients are not satisfied with their prostheses. Fifty-seven percent are dissatisfied with the comfort of their ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01270-0

Adjustable prosthetic sockets: a systematic review of industrial ... This paper reviews adjustable socket designs, as they have the potential to improve prosthetic fit and comfort through accommodating residual limb volume ...

4. researchgate.net researchgate.net/publication/322667772_Sockets_for_Limb_Prostheses_A_Review_of_Existing_Technologies_and_Open_Challenges

(PDF) Sockets for Limb Prostheses: A Review of Existing ... Indeed, several amputees still reject their prostheses or report a low satisfaction level, due to factors dealing with the socket-tissues interaction. The aim ...

5. jps.library.utoronto.ca jps.library.utoronto.ca/index.php/cpoj/article/view/36065

CLINICAL OUTCOME OF TRANSFEMORAL DIRECT ... The study showed significant improvements in stability, comfort, mobility, and quality of life with the Direct Socket TF system, making it a ...

6. mdpi.com mdpi.com/2076-3417/14/9/3708

Identifying Users' Needs to Design and Manufacture 3D ... This paper presents a questionnaire to assess the needs of upper limb prosthetics users or potential users, as well as a survey-based study with 18 respondents.

7. scholarscommons.fgcu.edu scholarscommons.fgcu.edu/view/pdfCoverPage?instCode=01FALSC_FGCU&filePid=13288061990006570&download=true

development of a low-budget prosthetic socket weave design The objective data provides information to help recommend certain safety aspects to incorporate when using the device. For example, if the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03927404

Development of Adaptive Vacuum Suspension to Improve ... A harness system will be used to provide support and safety for the amputees while study participants walk on the treadmill for 6 minutes. Official Title.

9. researchgate.net researchgate.net/publication/359057877_The_Impact_of_Limited_Prosthetic_Socket_Documentation_A_Researcher_Perspective

The Impact of Limited Prosthetic Socket Documentation The majority of limb prostheses are socket mounted. For these devices, the socket is essential for adequate prosthetic suspension, comfort, ...