Glide Control for Upper Extremity Amputation

Overseen By Rahul R Kaliki, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Infinite Biomedical Technologies

Disqualifiers: Unhealed wounds, Cognitive deficits, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

7 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis. This study will compare the use of Glide \[Experimental\] prosthesis with a DC \[Standard\] prosthesis in a clinical setting and in unsupervised daily activity. We will follow a multiple baseline design, specifically an AB design. Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks. The A phase is the baseline phase where the DC prosthesis will be used, and the B phase will be the treatment phase where the Glide prosthesis will be used. Participants will undergo an A phase of either 10-weeks, 12-weeks, or 14-weeks duration, with the remaining 14-, 12-, or 10-weeks of the study being dedicated to the B phase.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the study team.

What data supports the effectiveness of the treatment Glide Control Strategy, Glide Myoelectric Control Algorithm, Glide Control Strategy for upper extremity amputation?

Research shows that myoelectric control, which is part of the Glide Control Strategy, has been effectively used for over 30 years to help people control prosthetic limbs. This type of control allows for more natural and easier operation of prosthetic devices, making it a reliable option for improving function in individuals with upper limb amputations. ^{1 2 3 4 5}

Is the Glide Control for Upper Extremity Amputation generally safe for humans?

The research on myoelectric control systems, which includes various control strategies for prosthetic limbs, has been ongoing for decades and is considered reliable and durable in most situations. While specific safety data for Glide Control is not mentioned, myoelectric control systems have been used extensively and are generally safe for human use. ^{3 4 6 7 8}

How does the Glide Control Strategy treatment differ from other treatments for upper extremity amputation?

The Glide Control Strategy is unique because it uses a myoelectric control algorithm that allows for more natural and intuitive control of prosthetic limbs by creating additional control signals through nerve transfers to spare muscles. This enables simultaneous control of multiple joints, offering a more seamless and functional experience compared to traditional prosthetic control methods. ^{1 2 3 9 10}

Eligibility Criteria

This trial is for individuals with upper extremity amputation. Participants will use two types of prosthetic arms: a standard Direct Control (DC) prosthesis and an experimental Glide prosthesis, over a period of 24 weeks to compare functionality, satisfaction, and usage.

Inclusion Criteria

Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist

I have lost one arm.

Minimal residual limb length for myoelectric control as determined by the clinical team

Exclusion Criteria

My health issues are under control.

My amputation site has not fully healed.

My limb's condition may prevent me from fully participating in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline (A Phase)

Participants use the Direct Control (DC) prosthesis for baseline measurements and daily activities

10-14 weeks

Weekly data submission via web portal

Crossover

Participants transition from DC to Glide control strategy and receive occupational therapy training

1 week

1 visit (in-person)

Treatment (B Phase)

Participants use the Glide prosthesis for treatment measurements and daily activities

10-14 weeks

Weekly data submission via web portal

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Glide Control Strategy

Trial Overview The study aims to determine if the Glide prosthesis offers better performance than the standard DC prosthesis. Subjects will first use the DC arm for up to 14 weeks followed by the Glide arm for the remaining time in a clinical setting and daily life.

Participant Groups

Group I: Multiple Baseline Experimental Treatment 2 Interventions

Participants act as their own controls. Participants are fit with a prosthesis system, which includes IBT's Core2 controller, IBT Electrodes, FlexCell batteries, and prosthetic componentry chosen by the patient and their clinical team. The provided controller can operate in two modes of operation: (1) in Direct Control (or DC); and (2) using the Glide control strategy. Participants progress through an AB multiple baseline protocol, where they use the provided prosthesis system for four evaluation periods (totaling 24-weeks in duration). During the A-phase, participants use the system with DC and during the B-phase, participants use the system with the Glide control strategy. For both interventions, the required hardware is the same, while the control software will differ.

Glide Control Strategy is already approved in United States, European Union for the following indications:

Approved in United States as Glide Myoelectric Control Algorithm for:

• Upper limb amputation
• Partial hand limb loss

Approved in European Union as Glide Control Strategy for:

• Upper limb amputation
• Partial hand limb loss

Who Is Running the Clinical Trial?

Infinite Biomedical Technologies

Lead Sponsor

Trials

7

Recruited

160+

Advanced Arm Dynamics

Collaborator

Trials

1

Recruited

7+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Recent advancements in prosthetic devices and neuroprosthetic control strategies have significantly improved the rehabilitation of amputees, allowing for more natural and intuitive use of prosthetic limbs.

Refined surgical techniques now enable precise recording and stimulation of nerve signals in residual limbs, enhancing the control of prosthetics and providing users with a more realistic experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Realizing Upper Extremity Bionic Limbs: Leveraging Neuroprosthetic Control Strategies. Ganesh Kumar, N., Chestek, CA., Cederna, PS., et al.[2023]

A novel method for controlling myoelectric upper limb prostheses involves transferring residual nerves to spare muscles, creating additional control signals that allow for more natural and simultaneous control of multiple prosthetic movements.

This technique has been successfully implemented in one shoulder disarticulation and one transhumeral amputee, resulting in a significant increase in functional range-of-motion and the ability to perform tasks like picking up objects, which were previously difficult.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prosthetic command signals following targeted hyper-reinnervation nerve transfer surgery. Kuiken, T., Miller, L., Lipschutz, R., et al.[2022]

Myoelectric control has been an effective method for controlling upper limb prostheses for over 30 years, demonstrating reliability and durability in various situations.

The future of prosthetic technology lies in integrating multiple control schemes and utilizing advancements like microprocessors to enhance functionality, aiming to better replicate the natural movement and appearance of the human arm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity myoelectric prosthetics. Uellendahl, JE.[2005]

The evaluation of the University of New Brunswick 3-state myoelectric control system involved 11 amputees and was conducted by a 14-person interdisciplinary team, ensuring a comprehensive assessment of the device's benefits.

This myoelectric control system allows for on/off control of a powered hand using a single muscle, making it suitable for patients with limited control sites, which could enhance functionality for below-elbow and forequarter amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of UNB 3-state myoelectric control for arm prostheses. Paciga, JE., Gibson, DA., Gillespie, R., et al.[2007]

A new evaluation tool was developed to objectively assess the performance of myoelectric control strategies for upper limb prostheses, showing that it effectively follows Fitts' law for both direct and pattern recognition control methods.

Pattern recognition control significantly outperformed direct control in terms of throughput, indicating it may provide better real-time control for users of myoelectric prostheses, while maintaining similar completion rates and path efficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time comparison of conventional direct control and pattern recognition myoelectric control in a two-dimensional Fitts' law style test. Wurth, SM., Hargrove, LJ.[2020]

A study involving six transradial prosthesis users demonstrated that using a bespoke electrode housing unit significantly improved the functionality of myoelectric prostheses compared to conventional housings.

The research highlights that secure electrode contact and proper alignment with the residual limb are crucial for effective prosthesis use, suggesting that adjustable electrode housing can enhance performance, especially in challenging fitting situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of an adjustable electrode housing unit to compare electrode alignment and contact variation with myoelectric prosthesis functionality: A pilot study. Head, JS., Howard, D., Hutchins, SW., et al.[2017]

The University of New Brunswick has been researching myoelectric controls for prosthetics since 1960, focusing on creating systems that cater to specific clinical needs, such as for amputees with limited muscle control.

Recent advancements in electromechanical systems suggest that more sophisticated multifunction prosthetic controls will soon be available for clinical use, enhancing functionality and appearance, especially for children and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myoelectric control systems research at the Bio-Engineering Institute, University of New Brunswick. Scott, RN.[2006]

A new regression-based control method for myoelectric hand prostheses allows users to simultaneously and proportionally control two functions, improving usability compared to traditional methods that only allow one function at a time.

In tests involving daily life activities with five prosthetic users, this new approach demonstrated robust performance across different arm positions and days, outperforming existing clinical control techniques in most scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous control of multiple functions of bionic hand prostheses: Performance and robustness in end users. Hahne, JM., Schweisfurth, MA., Koppe, M., et al.[2021]

A nine-year-old girl with a congenital above-elbow amputation successfully used a myoelectrically controlled prosthesis that allows her to control both the hand and elbow through muscle signals from her biceps and triceps.

Two control methods were tested: a three-level method and a contraction-rate detection method, with the latter proving to be more effective for the patient, leading to daily use and continuous improvement in her control abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myoelectric elbow and hand prosthesis controlled by signals from 2 muscles only, in a 9 year old girl. Philipson, L., Sörbye, R.[2017]

The new control scheme for myoelectric prostheses allows for a wider variety of grip types based on the user's muscle contractions, improving functionality for amputees.

This system utilizes adaptive control parameters tailored to the patient's anatomy, enhancing the responsiveness and usability of the FZK-prosthesis through real-time data processing by a microcontroller.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Expanding control possibilities of myoelectric hand prostheses]. Reischl, M., Mikut, R., Pylatiuk, C., et al.[2019]

References

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

Realizing Upper Extremity Bionic Limbs: Leveraging Neuroprosthetic Control Strategies. [2023]

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

Prosthetic command signals following targeted hyper-reinnervation nerve transfer surgery. [2022]

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

Upper extremity myoelectric prosthetics. [2005]

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

Clinical evaluation of UNB 3-state myoelectric control for arm prostheses. [2007]

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

Real-time comparison of conventional direct control and pattern recognition myoelectric control in a two-dimensional Fitts' law style test. [2020]

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

The use of an adjustable electrode housing unit to compare electrode alignment and contact variation with myoelectric prosthesis functionality: A pilot study. [2017]

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

Myoelectric control systems research at the Bio-Engineering Institute, University of New Brunswick. [2006]

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

Simultaneous control of multiple functions of bionic hand prostheses: Performance and robustness in end users. [2021]

9. France pubmed.ncbi.nlm.nih.gov

Myoelectric elbow and hand prosthesis controlled by signals from 2 muscles only, in a 9 year old girl. [2017]

10. Germany pubmed.ncbi.nlm.nih.gov

[Expanding control possibilities of myoelectric hand prostheses]. [2019]