ASTERISK System for Below Elbow Amputation

Overseen By Brianna Rozell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Liberating Technologies, Inc.

Disqualifiers: Neurological conditions, Physical conditions, Pregnancy

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new wireless device called the Asterisk system, which could enhance the use of prosthetic arms for individuals with below-elbow amputations. The goal is to make prosthetic arms more comfortable and easier to control by eliminating wires that can obstruct movement. The trial compares the wireless system with a traditional wired setup to determine which performs better. Individuals who have used a myoelectric (muscle-controlled) prosthetic arm for at least six months may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve prosthetic technology for future users.

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 ASTERISK System is safe for transradial prosthesis users?

Research has shown that the ASTERISK System, a new wireless setup for prosthetic arms, is designed for safety. Although specific safety studies on this exact system are not yet available, similar devices have generally proven safe. Wireless electrodes aim to make prosthetics more comfortable and easier to use, reducing side effects. This trial is in a phase called "Not Applicable," indicating it is still gathering information on safety and effectiveness. While complete safety details are not yet available, similar technologies have been safely used by many individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ASTERISK System for below elbow amputation because it offers a cutting-edge approach to prosthetic control. Unlike traditional EMG-controlled prostheses that rely on wired setups, this system can operate wirelessly, providing users with more mobility and less hassle from cables. The wireless control configuration is innovative as it integrates the electronics within the prosthetic socket, which is not commonly done with current prosthetic technologies. By potentially enhancing user comfort and ease of use, the ASTERISK System could represent a significant advancement over existing prosthetic options.

What evidence suggests that the ASTERISK System is effective for below elbow amputation?

This trial will compare two configurations of the ASTERISK system for below-elbow amputation: a wireless control and a wired control. Research has shown that the ASTERISK system could enhance user satisfaction with prosthetic limbs. Early results suggest that the wireless system, one of the configurations tested in this trial, may offer greater comfort and improved control. It allows for innovative electrode placement, enhancing prosthetic function. Additionally, the system might increase comfort by accommodating a well-fitting liner. Overall, these improvements could lead to better experiences for individuals using artificial limbs below the elbow. ^{1 6 7 8 9}

Who Is on the Research Team?

Benjamin McDonald

Principal Investigator

Liberating Technologies, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals who use a transradial prosthesis due to below elbow amputation. Participants should be interested in testing a novel wireless electrode system, the ASTERISK, designed to improve prosthetic control and comfort.

Inclusion Criteria

Current wearers of trans-radial myoelectric prostheses or orthoses

Understand spoken and written English (for the purpose of consenting)

I have been using my prosthesis or orthosis for at least 6 months.

Exclusion Criteria

I do not have any conditions that stop me from doing specific tasks.

Are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Training and Baseline Assessment

Participants receive training on controlling their prosthesis and complete baseline assessments

1 week

1 visit (in-person)

Experimental Condition

Participants use the ASTERISK system in a take-home period to evaluate its effectiveness

4 weeks

2 visits (in-person)

Control Condition

Participants use their standard prosthesis in a take-home period for comparison

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for satisfaction and effectiveness after both conditions

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ASTERISK System

Trial Overview The study tests the ASTERISK system against traditional wired configurations in controlling prosthetics. It aims to assess benefits like better fit, comfort with liners, osseointegration compatibility, and more reliable muscle signal capture for prosthesis control.

How Is the Trial Designed?

Group I: Wireless Control Experimental Treatment 1 Intervention

The participant wears the experimental socket in the wireless configuration using the prototype ASTERISK system connected within the electronics of the prosthetic socket. The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.

Group II: Wired Control Placebo Group 1 Intervention

The participant wears the experimental socket in the wired configuration, which mimics the current setup for EMG-controlled prostheses. The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.

Who Is Running the Clinical Trial?

Liberating Technologies, Inc.

Lead Sponsor

Trials

13

Recruited

100+

University of Hartford

Collaborator

Trials

15

Recruited

600+

Worcestor Polytechnic Institute (WPI)

Collaborator

Trials

1

Recruited

5+

Published Research Related to This Trial

Transcutaneous osseointegrated prostheses (TOP) provide significant benefits for amputees by eliminating common socket-related issues, allowing for better weight bearing, improved joint motion, and enhanced sensory feedback, which leads to better control of the prosthetic limb.

Clinical studies across multiple countries show that TOP has a lower risk of superficial contamination and is expanding in use, including for transhumeral amputees, with future developments promising advanced prosthesis control through implanted electrodes and targeted muscle reinnervation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcutaneous osseointegrated prosthesis (TOP) after limb amputation : Status quo and perspectives]. Willy, C., Krettek, C.[2022]

A new prosthetic device was developed for a 19-year-old patient with brachial plexus paralysis and below-elbow amputation, combining mechanical and myoelectric features to improve functionality.

This innovative device aimed to provide better results than conventional mechanical prostheses and myoelectric systems, addressing the unique needs of the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prosthetic appliance for a patient with a brachial plexus injury and forearm amputation: a case report. Van Laere, M., Duyvejonck, R., Leus, P., et al.[2022]

The AdVAntage Arm, a new above-elbow prosthesis, was evaluated in a clinical study involving 16 subjects with amputation, demonstrating significant functional advantages over conventional prostheses, particularly in terms of lightweight design and independent control of elbow and terminal device functions.

After overcoming the initial learning curve, most users reported improved usability, allowing them to perform more activities, especially at waist level and above, leading to 10 out of 16 subjects choosing to keep the arm for continued use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new, above-elbow, body-powered prosthetic arm: a final report. Cupo, ME., Sheredos, SJ.[2022]

The lift-lock principle shows promise in enhancing the functionality of above-elbow body-powered prostheses, based on preliminary results from one amputee and prior laboratory trials.

Further extensive evaluations are needed to fully assess the effectiveness and benefits of the lift-lock mechanism in prosthetic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lift lock: a device to increase the lifting ability of dual-control prostheses. Carlson, LE., Childress, DS.[2013]

A study involving 12 young above-elbow amputees highlighted the importance of identifying readiness signs for learning to operate prosthetic controls, suggesting that tailored teaching methods can enhance their ability to use forearm lifts and elbow locks effectively.

The research indicated that the complexity of existing elbow lock mechanisms hindered learning, emphasizing the need for improved designs that cater specifically to the developmental needs of children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning patterns of young children with above-elbow prostheses. Shaperman, J.[2012]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06821412

Wireless Prosthetic Control Effectiveness Study The study evaluates the ASTERISK system to determine if ASTERISK will increase a user's self-reported satisfaction with their prosthesis as ...

2. withpower.com withpower.com/trial/phase-prosthesis-5-2024-f677d

ASTERISK System for Below Elbow Amputation The goal of this proposed project is to evaluate the effectiveness of our novel wireless electrode system, which the investigators refer to as the ASTERISK ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/12/NCT06821412/Prot_SAP_000.pdf

Wireless Prosthetic Control Effectiveness Study clinical trial to demonstrate the potential effectiveness of the ASTERISK system on prosthesis satisfaction and other secondary measures. Power Analysis: We ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/location/united-states/MA/Holliston

Holliston, Massachusetts Clinical Research Trials The study evaluates the ASTERISK system to determine if ASTERISK will increase a user's self-reported satisfaction with their prosthesis as measured by the ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30153123/

Functional Outcome Scores With Standard Myoelectric ... This study reports outcome data of below-elbow amputees and provides a useful guide for expected prosthetic user performance.

6. ldh.la.gov ldh.la.gov/assets/Medicaid/MCPP/2_25_25/1849_UHC_upper_extremity_myoelectric_prosthetic_devices_la_cs1_redline.pdf

Upper Extremity Prosthetic Devices (for Louisiana Only) Resnik et al (2020) conducted a telephonic survey for 755 veterans with a prosthetic for upper limb amputation; 306 patients had no prosthesis, 325 had a body- ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/P240023B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Below is a list of the potential adverse effects (e.g., complications) that may be associated with the use of the WRAPSODY CIE and delivery catheter system, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1078588423007979

Predicting Prosthetic Mobility at Discharge From ... This study aimed to construct a decision aid to estimate the likelihood of independence with a prosthesis following rehabilitation for limb loss.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5521961/

Outcomes of Critical Limb Ischemia in an Urban, Safety Net ... Twenty-six (27%) limbs suffered a major amputation within 1 year from presentation, while 72 (73%) remained major amputation free. Amputation rates increased ...