Digital Prosthetics + Exercise for Diabetic Amputation

Overseen By Paolo Bonato, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Spaulding Rehabilitation Hospital

Disqualifiers: Bilateral amputation, Unstable contralateral limb, Severe limb pain, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 months

38 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Digital Prosthetic Interface Technology for diabetic amputation?

The research on pressure casting techniques for prosthetic sockets shows that prosthetic users experienced high satisfaction and improved physical function, suggesting that advanced prosthetic technologies can enhance user experience and mobility. Additionally, emerging technologies like sensorized robotic limbs and electrical stimulation for sensory feedback have the potential to address unmet needs in prosthetic users, indicating that similar advancements in digital prosthetic interface technology could be beneficial. ^{1 2 3 4 5}

Is the Digital Prosthetics + Exercise treatment generally safe for humans?

Research on prosthetic technology highlights the importance of safety protocols to manage risks like balance loss and injury during testing and training. While new technologies offer benefits, they also pose additional risks, and understanding these is crucial for safe implementation. ^{2 4 6 7 8}

How is the Digital Prosthetic Interface Technology treatment different from other treatments for diabetic amputation?

Digital Prosthetic Interface Technology is unique because it uses foot movements to control prosthetic limbs, allowing for simultaneous activation of multiple joints, which is not possible with traditional prosthetics that operate joints in a serial manner. This approach leverages the natural similarities between the upper and lower limbs, providing a more intuitive and efficient control method for amputees. ^{2 9 10 11 12}

What is the purpose of this trial?

The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.

Research Team

Paolo Bonato, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

This trial is for individuals with a lower limb amputation due to type 2 diabetes complications, who currently use a prosthesis and own a smartphone. They should be able to move at certain levels (K2 or K3) and have had their amputation within the last 4-16 months. People with bilateral amputations, unstable other limbs, conditions preventing exercise, current pregnancy, incompatible body measurements for technology use, or severe limb pain are excluded.

Inclusion Criteria

Own a smartphone

I had one lower leg amputated between 4 and 16 months ago.

My condition is due to complications from Type 2 Diabetes.

Exclusion Criteria

I have had both of my limbs amputated.

Current pregnancy

Your residuum (the remaining part of the limb after amputation) is too big for the equipment used to make the prosthetic socket.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements including SEQ, PEQ, and thermal imaging of the residuum are conducted

1 week

1 visit (in-person)

Treatment

Participants are randomized to either digital prosthetic interface technology or traditional socket-liner technology, combined with an exercise intervention

12 months

Monthly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on step counts and intra-socket interface pressure

4 weeks

Treatment Details

Interventions

• Digital Prosthetic Interface Technology

Trial Overview The study examines new socket and liner technology in digital prosthetic interfaces combined with an exercise program aimed at improving health in people who've lost a lower limb from diabetes-related issues. Participants will try out this tech-and-exercise combo to see how well it works.

Participant Groups

Group I: digital prosthetic interface technology group Experimental Treatment 1 Intervention

Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.

Group II: traditional socket and liner technology group Active Control 1 Intervention

Study participants randomized to this group will use a traditional socket-liner technology (i.e., study participants will use their own liner and socket system).

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Bionic Skins LLC

Collaborator

Trials

1

Recruited

40+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A new digital Patient Decision Aid (PDA-TULA) was developed to help adults with major unilateral upper limb absence make informed choices about terminal devices (TDs) for prosthesis selection, based on a systematic co-creation process involving patients, clinicians, and experts.

The PDA-TULA includes comprehensive information about TDs, allows users to reflect on their personal values, and facilitates comparison of TD options tailored to individual preferences, potentially improving decision-making and reducing rejection rates of prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The systematic and participatory development of a patient decision aid about terminal devices for people with upper limb absence: The PDA-TULA. Kerver, N., Boerema, L., Brouwers, MAH., et al.[2023]

The DARPA Revolutionizing Prosthetics 2009 program developed a Virtual Integration Environment (VIE) that allows researchers and clinicians to collaboratively design and test prosthetic limbs, enhancing the integration of these devices with patient needs.

The VIE is being used by the Walter Reed Military Amputee Research Program to study and potentially reduce phantom limb pain in upper extremity amputees by modeling daily activities and capturing real-time muscle activity from the residual limb.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a virtual integration environment in treating phantom limb pain. Zeher, MJ., Armiger, RS., Burck, JM., et al.[2011]

The pressure casting technique (PCAST) for creating transtibial prosthetic sockets was successfully used on 13 adult volunteers, with a 62% success rate in fitting the prosthesis, indicating its potential for use in developing countries with limited resources.

Participants who used the prosthesis for an average of 167 days reported high satisfaction levels and showed significant improvements in physical function, such as faster timed up-and-go and longer six-minute walk distances, suggesting that PCAST can enhance mobility for individuals with unilateral amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure casting technique for transtibial prosthetic socket fit in developing countries. Lee, PV., Lythgo, N., Laing, S., et al.[2022]

Current prostheses for individuals with upper limb amputation or congenital limb difference are inadequate, leading to issues like rejection and pain, highlighting the need for improved solutions.

Emerging technologies such as robotic limbs and osseointegrated prostheses show promise in meeting user needs, but they also introduce new risks that must be carefully evaluated through user perspectives and feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity prosthesis user perspectives on unmet needs and innovative technology. Benz, HL., Jia Yao, ., Rose, L., et al.[2022]

A Prosthetic Interventions Core Outcome Set (PI-COS) was developed through a Delphi survey involving 65 prosthesis users and 8 funders, identifying 14 key outcome categories that are most important for evaluating prosthetic interventions.

The established PI-COS focuses on critical areas such as mobility, sensory functions, and general tasks, which can guide future clinical practices and research in prosthetics, ensuring that the outcomes measured align with user and funder priorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Core Outcome Set for users and funders of lower-limb prosthetic interventions (PI-COS): a step to inform the benefits measured in prosthetic health economic evaluations. Clarke, L., Ridgewell, E., Dillon, MP.[2023]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

A structured protocol for testing lower limb prostheses emphasizes safety, requiring users to meet specific graded safety levels before progressing to more challenging environments.

This approach aims to reduce the risk of falls and injuries, thereby enhancing user confidence and overall experience with active prosthetic legs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. Thesleff, A., Ahkami, B., Anderson, J., et al.[2022]

The DARPA RE-NET Program aims to enhance neuroprosthesis technology for amputees by developing reliable neural interfaces that can effectively control robotic prostheses throughout the user's lifetime.

The program focuses on three key areas: ensuring long-term stability of neural interfaces, creating reliable connections to peripheral nerves, and improving central nervous system interfaces, all crucial for effective prosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural interfaces for upper-limb prosthesis control: opportunities to improve long-term reliability. Judy, JW.[2016]

The DEKA Arm, an advanced upper limb prosthesis, can be effectively controlled using foot controls, which were positively received by most of the 36 amputee subjects in the study.

With training, users were able to develop the necessary skills to operate the foot controls, indicating that this method can enhance the functionality of multifunction prostheses despite initial challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling a multi-degree of freedom upper limb prosthesis using foot controls: user experience. Resnik, L., Klinger, SL., Etter, K., et al.[2014]

New prosthetic designs and advanced rehabilitation programs are now tailored to meet the fitness and performance needs of active amputees, allowing them to engage in a variety of sports and activities.

Collaboration among surgeons, prosthetists, and trainers has significantly improved the functionality of prostheses, enabling amputees to compete successfully in sports, highlighting a shift in focus from merely adapting to thriving with prosthetic technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in recreational prostheses and adaptive devices for the amputee. Michael, JW., Gailey, RS., Bowker, JH.[2022]

The proposed prosthesis control technique utilizes a stocking with multiple sensors on the foot and leg to provide input for controlling an upper extremity prosthetic, allowing for more natural and simultaneous joint movements.

This innovative approach addresses the limitations of current commercial prosthetics, which typically operate joints in a serial manner, making them less intuitive and more difficult to use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling an artificial arm with foot movements. Luzzio, CC.[2022]

The rate of lower limb amputation in diabetic patients is decreasing, but it remains a significant complication, highlighting the ongoing need for effective prosthetic solutions.

Recent advancements in prosthetic technology and design have improved the mechanics of ambulation for below knee, ankle, and foot amputees, enhancing their mobility and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prosthetic options available for the diabetic lower limb amputee. Chitragari, G., Mahler, DB., Sumpio, BJ., et al.[2022]

References

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

The systematic and participatory development of a patient decision aid about terminal devices for people with upper limb absence: The PDA-TULA. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Using a virtual integration environment in treating phantom limb pain. [2011]

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

Pressure casting technique for transtibial prosthetic socket fit in developing countries. [2022]

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

Upper extremity prosthesis user perspectives on unmet needs and innovative technology. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Development of a Core Outcome Set for users and funders of lower-limb prosthetic interventions (PI-COS): a step to inform the benefits measured in prosthetic health economic evaluations. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

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

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. [2022]

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

Neural interfaces for upper-limb prosthesis control: opportunities to improve long-term reliability. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Controlling a multi-degree of freedom upper limb prosthesis using foot controls: user experience. [2014]

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

New developments in recreational prostheses and adaptive devices for the amputee. [2022]

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

Controlling an artificial arm with foot movements. [2022]

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

Prosthetic options available for the diabetic lower limb amputee. [2022]