16 Participants Needed

MyoTrain for Upper Extremity Amputation

RR
Overseen ByRahul R Kaliki
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Infinite Biomedical Technologies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who are provided the MyoTrain system). The investigators will test three hypotheses: 1. The use of MyoTrain results in skills transference to control of the final prosthesis 2. The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures 3. The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics Following a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo clinical assessment. Post-device delivery, participants will then complete 3 56-day blocks of at-home prosthesis use, in between which they will return to clinic for assessment.

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 data supports the effectiveness of the treatment 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 ability to perform complex motions. This suggests that MyoTrain, which uses a virtual-limb training system, may help individuals learn to use their prostheses more effectively.12345

Is MyoTrain safe for human use?

The studies reviewed do not report any specific safety concerns related to MyoTrain or similar training systems for myoelectric prostheses. Participants in these studies generally found the training methods comfortable and usable, suggesting they are safe for human use.15678

How is the MyoTrain treatment different from other treatments for upper extremity amputation?

MyoTrain is unique because it uses a virtual reality system to train individuals with upper extremity amputations to control advanced prosthetic limbs, allowing them to practice muscle movements and control schemes in a simulated environment before receiving their prosthesis. This approach is more engaging and can be done at home, making it different from traditional training methods that often require in-person sessions with a therapist.19101112

Eligibility Criteria

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
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 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: ControlActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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.
Virtual Integration Environment as an Advanced Prosthetic Limb Training Platform.Perry, BN., Armiger, RS., Yu, KE., 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.
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.
Clinical evaluation of the revolutionizing prosthetics modular prosthetic limb system for upper extremity amputees.Yu, KE., Perry, BN., Moran, CW., et al.[2022]

References

Virtual Integration Environment as an Advanced Prosthetic Limb Training Platform. [2020]
Evaluating the Ability of Congenital Upper Extremity Amputees to Control a Multi-Degree of Freedom Myoelectric Prosthesis. [2022]
Clinical evaluation of the revolutionizing prosthetics modular prosthetic limb system for upper extremity amputees. [2022]
Limb loading enhances skill transfer between augmented and physical reality tasks during limb loss rehabilitation. [2023]
Mobile, Game-Based Training for Myoelectric Prosthesis Control. [2020]
Upper extremity prosthesis user perspectives on unmet needs and innovative technology. [2022]
Creating a standardized, quantitative training protocol for upper limb bypass prostheses. [2020]
A Multi-User Transradial Functional-Test Socket for Validation of New Myoelectric Prosthetic Control Strategies. [2023]
Game-Based Rehabilitation for Myoelectric Prosthesis Control. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
A novel myoelectric training device for upper limb prostheses. [2014]
MSMS software for VR simulations of neural prostheses and patient training and rehabilitation. [2011]
12.United Statespubmed.ncbi.nlm.nih.gov
A Myoelectric Postural Control Algorithm for Persons With Transradial Amputations: A Consideration of Clinical Readiness. [2022]
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