Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss
NCT ID: NCT05888428
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2024-02-02
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental
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.
MyoTrain
MyoTrain is a virtual prosthesis control training system. From a hardware perspective it consists of an Apple iPad tablet computer and an eight-channel EMG armband, based on the Element electrode platform, which interfaces with the tablet via Bluetooth™. From a software perspective, MyoTrain was developed in the cross-platform Unity 4.0 game development environment.
Control
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.
Motor Imagery
Motor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement.
Interventions
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MyoTrain
MyoTrain is a virtual prosthesis control training system. From a hardware perspective it consists of an Apple iPad tablet computer and an eight-channel EMG armband, based on the Element electrode platform, which interfaces with the tablet via Bluetooth™. From a software perspective, MyoTrain was developed in the cross-platform Unity 4.0 game development environment.
Motor Imagery
Motor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement.
Eligibility Criteria
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Inclusion Criteria
* Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist
* Fluent in English
* Age of 18 years or greater
Exclusion Criteria
* Patients with a residual limb that is unhealed from the amputation surgery
* Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
* Unhealed wounds
* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impactive full participation in the study as determined upon clinical evaluation
* Serious uncontrolled medical problems as judged by the project therapist
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Johns Hopkins University
OTHER
Hanger Clinic: Prosthetics & Orthotics
OTHER
Infinite Biomedical Technologies
INDUSTRY
Responsible Party
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Rahul Kaliki
Chief Executive Officer
Locations
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Hanger Clinic - Grand Rapids
Grand Rapids, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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