Untethered Home Therapy System
Department of Health and Human Services
Agency Tracking Number:
Solicitation Topic Code:
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, 44103
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess an Untethered Home Therapy System (UHTS). The proposed system should speed the time course and increase the amount of functional recovery from upper extremity motor deficits resulting from a stroke. There currently has been tremendous growth and active research into brain plasticity and motor relearning after stroke. The proposed UHTS will provide a home-based system for continuing and monitoring therapy. Allowing patients to continue therapy at home with flexibility around their schedule should increase therapy time and hence functional improvement. Additionally, it will provide underprivileged better access for therapy. The patient and/or their caregiver could be easily trained to use the UHTS. The proposed UHTS will utilize wearable sensing and stimulating technology to automatically modulate functional electrical stimulation (FES) and improve therapy. The UHTS will employ a lightweight, easy to wear sleeve embedded with dry surface electromyography (EMG) electrodes, motion sensors, a stimulator unit, and radio transceiver. The untethered design will increase patient safety and allow patients to break without removing the device. EMG and kinetic data will be transmitted from the sleeve to a nearby laptop computer. A dynamic clinical movie will instruct subject therapy tasks, including a variety of simple and complex arm movements, grasp force tracking, EMG and/or position tracking, and grasp force tasks. Each task will be repeated for a specific clinician prescribed time period. By monitoring EMG and kinetic signals we will discriminate therapy tasks, monitor compliance time, and provide feedback. Additionally, movements, coordination patterns, and/or EMG will be used as inputs to an algorithm trained to output an appropriate level of FES to target muscles that will assist therapy. In other words, it will automatically detect when a user is trying to perform a therapy task they cannot voluntarily complete and assist with FES. A unique software interface will encourage patients through movie-based instruction, real-time feedback, and physician defined therapy goals. Quantitative measures related to functional improvement will be calculated and presented to clinicians in reports. Reports will be transmitted from patients' homes to a physician's office via the Internet so therapy can be monitored and modified on-line. Monitoring home therapy should give physicians a barometer for changing treatment protocols and ensuring compliance. Specifically during Phase II we will design, build, and clinically evaluate the telemetry sleeve design, upgrade and integrate algorithms for task discrimination and FES, and upgrade the user interface software. The UHTS will be clinically evaluated with fifty stroke subjects to ensure clinical efficacy. We hypothesize the UHTS will 1) accurately transmit data 2) accurately detect therapy tasks and apply FES when required, 3) provide effective subject feedback, and 4) improve motor recovery. The proposed untethered home therapy system should speed the time course and increase the amount of functional recovery from upper extremity motor deficits resulting from a stroke. The system will include a sleeve that the user can slip over their arm which will measure muscle activity and motion and supply real-time feedback with a video interface. The system will provide a home-based system for continuing and monitoring therapy and provide the underprivileged better access for therapy.
* information listed above is at the time of submission.