Regulatory clearance of a rehabilitation system for individuals with upper limb loss

Active Cooperative Agreement Awarded Last action

Award ID
U44NS119842
Recipient
Awarding agency
Obligated
$15,187,571

Award facts

Completion date 87% complete
Originally
Funding
  • $14,187,708.00 Federal
  • $999,863.00 Non-federal
Place of performance
Baltimore, MD 21202, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Our work to date has resulted in the development of several technologies focused on improving the lives of individuals with upper-limb loss (ULL). First, our sense pattern recognition control system (and associated element low-profile surface EMG electrodes and flexcell flexible lithium-polymer batteries) can interface with most myoelectric hands, wrists, and elbows on the market. Second, our myotrain virtual-limb pre-prosthetic training system has been demonstrated to help individuals with ULL learn to use pattern recognition. This system is valuable in the "golden window" time period after amputation but before IT is feasible to fit the patient with a definitive prosthesis. Based on our clinical experience, we identified three ways in which we could deepen our clinical impact, particularly as related to the myotrain system. First, we noted that EMG classification accuracy could be improved by decreasing intra-class scatter (improving repeatability) and/or increasing inter-class separation (improving separability). How individuals incorporate these methods is user specific and they could benefit from the incorporation of visual feedback - something that we call "active coaching". Second, our business model allows US to provide myotrain to the patient before reimbursement is available, which offers significant clinical advantage. However, this currently still requires the prosthetist to fabricate a check socket for use with each individual. We now propose to integrate a reusable wireless armband which would eliminate this issue. Third, we plan to evaluate the efficacy of myotrain with a prospective trial of our technology suite and associated clinical methodology. Specifically, we will test three hypotheses: 1) 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; and 3) use of myotrain results in improved clinical outcomes as measured by functional, subjective and usage metrics. The capstone of this project is the submission of a 510(k) premarket notification application for the myotrain system.

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Quick answers

Who received award U44NS119842?

U44NS119842 was awarded to Infinite Biomedical Technologies, LLC by National Institute of Neurological Disorders and Stroke (National Institutes of Health) on January 15, 2021.

How much is award U44NS119842 worth?

$15,187,571 has been obligated on U44NS119842: $14,187,708 in federal funding and $999,863 in non-federal funding.

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