MyoTrain for Upper Extremity Amputation

Overseen By Rahul R Kaliki

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 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new training system called MyoTrain for individuals who have lost an arm below the elbow. MyoTrain may help users better control their new prosthesis (artificial limb) through special exercises. The trial compares MyoTrain with standard exercises to determine which method improves prosthesis control and daily function more effectively. It is open to those who have lost one lower arm and are receiving a specific type of advanced prosthesis that moves in multiple ways. Participants should not have previously tried similar prosthetic control systems. As an unphased trial, this study provides a unique opportunity to explore innovative prosthetic training methods that could enhance daily life.

Do I need to stop my current medications for the MyoTrain 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 prior data suggests that the MyoTrain system is safe for individuals with upper-limb loss?

Research has shown that the MyoTrain system could assist people with upper limb loss. Although limited safety data exists specifically for humans, the trial is labeled "Not Applicable" for risk, indicating that MyoTrain is likely considered low-risk. This designation is common for studies on training or rehabilitation tools, which are generally safe due to their ease of use and non-invasive nature. For safety concerns, consider contacting the trial organizers for more details or reaching out to others who have used similar systems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional prosthetic training methods that mainly focus on muscle strengthening or motor imagery without real-time feedback, MyoTrain offers a comprehensive approach to rehabilitation for individuals with upper extremity amputations. MyoTrain is unique because it combines a wearable armband with interactive software on an iPad, allowing users to progress through training modules that develop complex hand and wrist control. This hands-on, tech-integrated system helps participants achieve more precise movements by providing real-time feedback and gradual training complexity, which is a significant leap forward in empowering users with more natural and intuitive prosthetic control.

What evidence suggests that the MyoTrain system is effective for upper extremity amputation?

Research has shown that virtual reality training platforms, like MyoTrain, effectively teach people with upper limb loss to control advanced prosthetic limbs. In this trial, participants in the experimental arm will use the MyoTrain system to practice controlling complex hand and wrist movements, enhancing their ability to use the prosthesis in everyday situations. Early results suggest that MyoTrain leads to improved outcomes, such as better function and higher user satisfaction. Overall, MyoTrain appears to enhance users' proficiency with their prosthetic limbs in daily life. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have lost a limb at the forearm level, are fluent in English, and qualify for an advanced myoelectric prosthesis. It's not suitable for those with other types of limb loss or conditions that would exclude them from using this technology.

Inclusion Criteria

Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist

Fluent in English

I have lost one arm.

Exclusion Criteria

Prior experience with pattern recognition control

Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes

Significant cognitive deficits as determined upon clinical evaluation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline functional assessment before starting the training period

1 day

Pre-prosthetic Training

Participants undergo a 30-day pre-prosthetic training period specific to their assigned group

4 weeks

1 visit (in-person)

Prosthetic Device Delivery and Occupational Therapy

Participants receive their prosthetic device and occupational therapy consistent with the current clinical care standard

1-2 weeks

At-home Prosthesis Use

Participants complete 3 blocks of 56-day at-home prosthesis use, with clinic assessments in between

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MyoTrain

Trial Overview The study compares standard motor imagery training (Control Group A) to the MyoTrain system (Group B) in helping individuals control their prosthetic devices after trans-radial amputation. Participants will be randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Participants will be provided with the take-home MyoTrain system, which includes the MyoTrain armband, iPad, and MyoTrain software. Participants will progress through the training modules of the MyoTrain software, starting with eliciting paired single DoF antagonistic movements and ending with the proportional control of complex, 2-DoF hand and wrist movements.

Group II: Control Active Control 1 Intervention

Participants will be provided motor imagery exercises that involve brief attempts to move the missing limb in a similar manner to how they would control their pattern recognition system to strengthen their muscles. These exercises do not involve any real-time control feedback.

MyoTrain is already approved in United States for the following indications:

Approved in United States as MyoTrain for:

• Pre-prosthetic training for individuals with upper limb loss

Who Is Running the Clinical Trial?

Infinite Biomedical Technologies

Lead Sponsor

Trials

7

Recruited

160+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Hanger Clinic: Prosthetics & Orthotics

Collaborator

Trials

11

Recruited

520+

Published Research Related to This Trial

Participants using augmented reality (AR) training with limb loading showed a significantly greater increase in their ability to complete tasks with a real prosthesis compared to those who trained without loading or performed simple muscle training.

The group that trained with limb loading not only improved more but also reached peak performance faster, indicating that incorporating limb loading into AR training can enhance the transfer of motor skills from virtual to physical environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limb loading enhances skill transfer between augmented and physical reality tasks during limb loss rehabilitation. Hunt, CL., Sun, Y., Wang, S., et al.[2023]

A virtual reality simulator effectively trained 13 military personnel with upper extremity loss to control advanced myoelectric prostheses, achieving over 95% accuracy in basic motion tasks and significant improvements in more complex tasks over time.

The training allowed participants to generate distinct muscle contraction patterns in their residual limbs, which were accurately interpreted by the prosthetic control system, highlighting the potential for intuitive control of prosthetic devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Integration Environment as an Advanced Prosthetic Limb Training Platform. Perry, BN., Armiger, RS., Yu, KE., et al.[2020]

A standardized training protocol for using a body-powered bypass prosthesis was developed and tested with six volunteers over ten two-hour sessions, revealing that optimal training lengths were three sessions for the modified Southampton Hand Assessment and six sessions for the Box and Blocks Test.

The study found a weak correlation between prepositioning and performance scores, suggesting that prepositioning may not significantly enhance the effectiveness of training with the prosthesis as previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a standardized, quantitative training protocol for upper limb bypass prostheses. Bloomer, C., Wang, S., Kontson, K.[2020]

A new low-cost, multi-user functional-test socket for transradial prosthetics was developed, allowing for rapid fitting and use in research, costing under $10 and taking less than 10 minutes to adjust for different users.

The socket did not hinder participants' performance in functional tasks or affect the quality of electromyography signals, and it was comfortable enough for at least 2 hours of use, promoting greater involvement of end-users in myoelectric prosthetic research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multi-User Transradial Functional-Test Socket for Validation of New Myoelectric Prosthetic Control Strategies. Hansen, TC., Citterman, AR., Stone, ES., et al.[2023]

The MSMS software tool allows researchers and engineers to simulate and evaluate the performance of neural prosthetic limbs before they are constructed, enhancing safety and efficiency in development.

MSMS also provides a virtual training environment for patients, enabling them to learn how to control their prostheses effectively before actual use, which can improve rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MSMS software for VR simulations of neural prostheses and patient training and rehabilitation. Davoodi, R., Loeb, GE.[2011]

A novel mobile, game-based training approach for myoelectric prostheses significantly improved muscle control, sequencing, and isolation in able-bodied participants, suggesting it could enhance training for amputees.

Participants found the game-based training highly usable and motivating, indicating its potential to increase rehabilitation success rates for amputees by allowing training outside clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile, Game-Based Training for Myoelectric Prosthesis Control. Winslow, BD., Ruble, M., Huber, Z.[2020]

A study involving 11 able-bodied participants showed that a video game-based rehabilitation protocol significantly improved muscle control metrics, such as fine accuracy and endurance, after just one session of EMG-controlled games.

The findings suggest that using engaging video games for training can enhance the controllability of myoelectric prostheses, potentially increasing motivation and effectiveness for users, especially if started before receiving the final prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Game-Based Rehabilitation for Myoelectric Prosthesis Control. Prahm, C., Vujaklija, I., Kayali, F., et al.[2020]

In a study involving seven participants aged 9 to 62 with unilateral congenital upper limb amputation, all successfully controlled a myoelectric prosthesis with multiple degrees of freedom using pattern recognition technology, achieving proficiency comparable to their sound limb.

The results indicate that both children and adults can effectively use myoelectric prostheses with pattern recognition control, suggesting significant potential benefits for this population in enhancing their functional capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Ability of Congenital Upper Extremity Amputees to Control a Multi-Degree of Freedom Myoelectric Prosthesis. Kaluf, B., Gart, MS., Loeffler, BJ., et al.[2022]

The Modular Prosthetic Limb (MPL) system allows individuals with upper extremity amputations to control an advanced prosthesis with greater accuracy and efficiency, enabling them to manage an average of eight motion classes compared to just three with conventional prostheses.

Participants showed significant improvements in their ability to control the MPL, as indicated by the Assessment of Capacity for Myoelectric Control (ACMC) scores, suggesting that the MPL can effectively enhance functionality for those with limb loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the revolutionizing prosthetics modular prosthetic limb system for upper extremity amputees. Yu, KE., Perry, BN., Moran, CW., et al.[2022]

The myoelectric postural control algorithm was tested in a laboratory setting with two trans-radial amputees, showing that it can be integrated into existing prosthetic systems.

The postural controller achieved an average of 66% hand function compared to an intact limb, indicating its potential effectiveness, although results were mixed when compared to a commercial state-of-the-art system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Myoelectric Postural Control Algorithm for Persons With Transradial Amputations: A Consideration of Clinical Readiness. Segil, JL., Kaliki, R., Uellendahl, J., 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 new training system for myoelectric prosthetic hands was developed to help upper limb amputees learn control schemes and muscle isolation, using a remote-controlled car for practice.

Preliminary testing with eight nonamputee volunteers showed that users improved their skills significantly during training, indicating the system's potential effectiveness for future use with amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel myoelectric training device for upper limb prostheses. Clingman, R., Pidcoe, P.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05888428

Study of Efficacy of the MyoTrain System in a Population ... The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics. Following a baseline functional assessment, ...

2. withpower.com withpower.com/trial/myotrain-for-upper-extremity-amputation-798fe

MyoTrain for Upper Extremity Amputation Research shows that virtual reality training platforms can effectively teach people with upper limb loss to control advanced prosthetic limbs, improving their ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05975970/a-patient-driven-augmented-reality-based-rehabilitation-system-to-improve-upper-limb-amputee-outcomes

A Patient-Driven Augmented Reality-Based Rehabilitation ... The investigators propose to evaluate the efficacy of MyoTrain AR in a prospective clinical study involving 10 individuals with trans-radial ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05975970?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Infinite%20Biomedical%20Technologies%22))&rank=2

A Patient-Driven Augmented Reality-Based Rehabilitation ... A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6232892/

Virtual Integration Environment as an Advanced Prosthetic ... A virtual reality training platform can be used to quickly and efficiently train individuals with UE loss to operate advanced prosthetic control paradigms.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10669061/

Virtual Technology for Upper Limb Amputee Training Review This study reviews the possible benefits of using virtual technology from four aspects: usability, flexibility, psychological affinity, and long-term ...