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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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 system, on transradial prosthesis users. There are numerous benefits to the upper limb prosthesis community being able to utilize wireless electrodes. These benefits include allowing for the use of a prosthetics liner to assist with fit and comfort, easier implementation of EMG-controlled prosthesis for individuals with osseointegration, and additional EMG electrode location options if the muscle activity captured within the prosthetic socket does not provide reliable prosthesis control. The investigators intend to use this data to develop the ASTERISK wireless electrode system into a commercial product. The findings will also be shared with the research community to help drive the design of future devices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the ASTERISK System treatment for below elbow amputation differ from other treatments?

The ASTERISK System is unique because it is specifically designed for below elbow amputations, whereas many existing prosthetic solutions focus on above-elbow or other types of amputations. This system may offer more tailored functionality and comfort for below elbow amputees compared to conventional prostheses. ^{1 2 3 4 5}

Research Team

Benjamin McDonald

Principal Investigator

Liberating Technologies, Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

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

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

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

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

A prosthetic appliance for a patient with a brachial plexus injury and forearm amputation: a case report. [2022]