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

Trial Summary

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 K-Socket-Harness treatment for amputees?

Research suggests that vacuum-assisted socket systems, which are similar to the K-Socket-Harness, can improve balance, gait (walking pattern), and limb health for amputees by providing better fit and volume control compared to other socket designs. ^{1 2 3 4 5}

Is the K-Socket-Harness safe for use in humans?

The research articles do not provide specific safety data for the K-Socket-Harness or similar devices, focusing instead on socket fit, manufacturing errors, and strength evaluation of prosthetic sockets. ^{4 6 7 8 9}

How is the K-Socket-Harness treatment for amputees different from other treatments?

The K-Socket-Harness treatment is unique because it likely involves a specialized harness system designed for amputees, which may offer a novel approach compared to traditional prosthetic socket systems. Unlike standard treatments, this harness could provide improved comfort or stability for amputees, although specific details are not provided in the available research. ^{10 11 12 13 14}

What is the purpose of this trial?

This research and development will improve upon and investigate the potential validity of an innovative new transradial socket and harness design (the KSH system) that offers an alternative to standard hard sockets and rubber liners with a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The project consists of designing, custom fitting and evaluating the function and comfort of the this new novel system. The study will take place in 3 phases; Phase 1, five experienced Veterans with transradial arm amputations will be recruited to provide guidance and to assist with the design and development. Experienced end-user Veterans and Clinical staff will work together to assist with design, develop the fitting process and working with engineers on the design of a completely digital fitting device for measuring the residual limb and locating bony prominences of the limb to inform the socket design. Phase 2, testing and assessment, the design and process validation will take place with the five Veteran upper transradial arm amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will perform a series of static and dynamic tasks to evaluate function, comfort and load bearing failure. The primary goal of this study is to improve upon the current preliminary prototype and to test it with a broader population of potential users to help advance the engineering and design, and to learn the potential to fit a range of Veterans with transradial amputations.

Research Team

Rory A Cooper, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Corrigendum. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Validation of a Custom Interface Pressure Measurement System to Improve Fitting of Transtibial Prosthetic Check Sockets. [2023]

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

Systematic review of effects of current transtibial prosthetic socket designs--Part 2: Quantitative outcomes. [2022]

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

Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume. [2015]

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

Perceived Effect of Socket Fit on Major Lower Limb Prosthetic Rehabilitation: A Clinician and Amputee Perspective. [2022]

6. France pubmed.ncbi.nlm.nih.gov

The comprehensive lower limb amputee socket survey: Reliability and validity of the persian version. [2021]

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

Computer-socket manufacturing error: how much before it is clinically apparent? [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[Criteria for socket type prescription: indications and contraindications of a liner system]. [2013]

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

Strength evaluation of prosthetic check sockets, copolymer sockets, and definitive laminated sockets. [2022]

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

Proximal Interphalangeal Arthrodesis of Lesser Toes Utilizing K-Wires Versus Expanding Implants: Comparative Biomechanical Cadaveric Study. [2020]

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

Treatment of femoral shaft fractures in children by intramedullary Kirschner wires. [2019]

12. France pubmed.ncbi.nlm.nih.gov

Biomechanical comparison of different implants for PIP arthrodesis. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Intramedullary Kirschner wire (K-wire) fixation of femoral fracture in children. [2021]

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

Hammertoe correction with k-wire fixation. [2015]