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Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss

RecruitingNAAges 18 Years - anyAllInfinite Biomedical Technologies
NCT05888428 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pro

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📋 Eligibility rules (as published)
Inclusion Criteria: * Trans-radial unilateral limb loss * 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: * Prior experience with pattern recognition control * 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
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What it tests

  • MyoTrain
  • Motor Imagery
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Where

1 site
Hanger Clinic - Grand Rapids
Grand Rapids, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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