SBIR-STTR Award

Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper-Extremity
Award last edited on: 2/19/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$3,716,328
Award Phase
2
Solicitation Topic Code
865
Principal Investigator
Joseph T Gwin

Company Information

BioSensics LLC

57 Chapel Street Suite 200
Newton, MA 02458
   (888) 589-6213
   info@biosensics.com
   www.biosensics.com
Location: Single
Congr. District: 04
County: Middlesex

Phase I

Contract Number: 1R44HD084035-01A1
Start Date: 9/8/2015    Completed: 6/30/2016
Phase I year
2015
Phase I Amount
$225,000
Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper-Extremity: Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. BioSensics, in partnership with the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, will develop wrist-worn sensors for motor retraining after stroke. Our simple technology will encourage affected limb use during the performance of activities of daily living, will remind patients to perform daily prescribed motor control exercises in the home environment, and will assess the quality of limb movement during these exercises. We hypothesize that adding long-term monitoring and biofeedback using wrist-worn sensors to traditional therapies will improve motor ability following stroke; particularly in cases where a high dosage of physical and occupational therapy is not feasible due to insurance coverage, lack of transportation, geography, or other limiting factors. The proposed device is the only telehealth system designed to encourage usage of the affected limb during activities of daily living. Many technologies exist to remotely monitor movement using wearable sensors, but none address the specific needs of patients with hemiparesis. Therefore, there is a significant opportunity to develop a first-to-market technology in this space. The team we have assembled for this collaborative project includes engineers, clinicians, and scientists from BioSensics (a privately held biomedical technology development company) and Spaulding Rehabilitation Hospital (the largest provider of rehabilitation medicine in New England). During Phase I of this Fast-Track SBIR project we will develop the wrist-worn sensors and test algorithms for assessing the quality and quantity of upper-limb movement in the home environment based on acceleration measured by these sensors. During Phase II we will develop the telehealth infrastructure for the proposed system, including a home base station that receives daily movement summaries from the wrist-worn sensors and uploads the data via WiFi or LAN to a HIPAA compliant server, and a website that clinicians can use to visualize data and remotely set patient specific exercise regimens and activity goals. We will also conduct a usability study and a clinical study at Spaulding Rehabilitation Hospital. The clinical study will compare rehabilitation outcomes between 30 patients with upper-extremity hemiparesis following stroke who receive standard care and supplemental home-based therapy and 30 patients who receive the same intervention but use the proposed system. There is a significant commercialization potential for the proposed technology due to 1) the size of the market, 2) the disruptive nature of our first-to-market technology, and 3) the ongoing national push for a transition from the current fee- for-service healthcare model to accountable-care-organization standards. We will have a market-ready device by the completion of Phase II with plans for a market launch during Phase III, pending FDA approval.

Public Health Relevance Statement:


Public Health Relevance:
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. We will develop wrist-worn sensors that encourage affected limb use during activities of daily living, remind patients to perform daily prescribed motor control exercises in the home environment, and assess the quality of limb movement during these exercises. This innovative therapeutic intervention will reduce socioeconomic and geographic disparities in rehabilitation outcomes by facilitating cost-effective in-home training.

Project Terms:
Acceleration; functional capacity; functional ability; daily living functionality; Activities of everyday life; Activities of Daily Living; Affect; Algorithms; Behavior; Biofeedback; Boston; Clinical Study; Clinical Research; Engineering; Physical Exercise; Exercise; Non-Trunk; Limbs; Extremities; Limb structure; Feedback; Geography; Goals; hemiparetic; Hemipareses; Hospitals; Interview; Laboratories; Learning; long-term study; Longitudinal Studies; Marketing; Motion; Locomotor Activity; Motor Activity; body movement; Movement; National Institutes of Health; NIH; United States National Institutes of Health; neuroplasticity; neural plasticity; CNS plasticity; Neuronal Plasticity; Northeastern United States; New England; Occupational Therapy; Patients; Rehabilitation Medicine; Physiatry; Physiatrics; Physical Medicine; rehabilitative; Rehabilitation; Physical Health Services / Rehabilitation; Medical Rehabilitation; Rehabilitation therapy; Safety; cerebrovascular accident; cerebral vascular accident; brain attack; Cerebrovascular Stroke; Cerebrovascular Apoplexy; Cerebral Stroke; Brain Vascular Accident; Apoplexy; stroke; Technology; Testing; Time; Transportation; Wrist; Measures; health care; Healthcare; Outcome Measure; Caring; base; dosage; sensor; improved; Clinical; Phase; Training; Visual; Individual; Recovery; Bilateral; Fees for Service; Fee-for-Service Plans; Viewpoint; Editorial Comment; Commentary; Comment; Published Comment; Wolves; Nature; Life; Insurance Status; Insurance Coverage; programs; Scientist; Severities; Home; Home environment; LOINC Axis 4 System; System; Visit; impaired balance; equilibrium disorder; disturbed balance; balance impairment; balance disorder; equilibration disorder; field study; limb movement; Performance; technology development; Rehabilitation Outcome; United States Health Insurance Portability and Accountability Act; Public Law 104-191; PL104-191; PL 104-191; Kennedy Kassebaum Act; HIPAA; Health Insurance Portability and Accountability Act; Categories; Devices; Neurological trauma; Neurological Injury; Neurological Damage; Nervous System damage; Nervous System Injuries; Nervous System Trauma; Biomedical Technology; intervention therapy; Therapeutic Intervention; Modeling; interventional strategy; Intervention Strategies; Intervention; Central Nervous System; CNS Nervous System; Neuraxis; Physiotherapy Procedure; Physiotherapy (Techniques); Physiotherapy; Physical Therapy Techniques; Physical Therapy Procedure; Physical Therapeutics; Physical Medicine Procedure; Physiatric Procedure; Physical therapy; Provider; Upper Limb; Membrum superius; Upper Extremity; telehealth; Address; Data; Motor; Infrastructure; Research Infrastructure; Small Business Innovation Research; SBIRS (R43/44); SBIR; Small Business Innovation Research Grant; STTR; Small Business Technology Transfer Research; Monitor; Process; socioeconomically; socioeconomic; socio-economic; socio economic; socioeconomics; developmental; Development; traditional therapy; website; web site; cost; telehealth systems; designing; design; Outcome; cost-effective; cost effective; Upper limb movement; Consumption; innovative; innovate; innovation; remote sensor; usability; constraint induced movement therapy; commercialization; motor control; telerehabilitation; public health relevance; standard treatment; standard care; clinical practice; Regimen; Secure; arm; recovered motor function; motor function recovery

Phase II

Contract Number: 4R44HD084035-02
Start Date: 9/8/2015    Completed: 10/31/2018
Phase II year
2017
(last award dollars: 2023)
Phase II Amount
$3,491,328

Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper-Extremity: Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. BioSensics, in partnership with the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, will develop wrist-worn sensors for motor retraining after stroke. Our simple technology will encourage affected limb use during the performance of activities of daily living, will remind patients to perform daily prescribed motor control exercises in the home environment, and will assess the quality of limb movement during these exercises. We hypothesize that adding long-term monitoring and biofeedback using wrist-worn sensors to traditional therapies will improve motor ability following stroke; particularly in cases where a high dosage of physical and occupational therapy is not feasible due to insurance coverage, lack of transportation, geography, or other limiting factors. The proposed device is the only telehealth system designed to encourage usage of the affected limb during activities of daily living. Many technologies exist to remotely monitor movement using wearable sensors, but none address the specific needs of patients with hemiparesis. Therefore, there is a significant opportunity to develop a first-to-market technology in this space. The team we have assembled for this collaborative project includes engineers, clinicians, and scientists from BioSensics (a privately held biomedical technology development company) and Spaulding Rehabilitation Hospital (the largest provider of rehabilitation medicine in New England). During Phase I of this Fast-Track SBIR project we will develop the wrist-worn sensors and test algorithms for assessing the quality and quantity of upper-limb movement in the home environment based on acceleration measured by these sensors. During Phase II we will develop the telehealth infrastructure for the proposed system, including a home base station that receives daily movement summaries from the wrist-worn sensors and uploads the data via WiFi or LAN to a HIPAA compliant server, and a website that clinicians can use to visualize data and remotely set patient specific exercise regimens and activity goals. We will also conduct a usability study and a clinical study at Spaulding Rehabilitation Hospital. The clinical study will compare rehabilitation outcomes between 30 patients with upper-extremity hemiparesis following stroke who receive standard care and supplemental home-based therapy and 30 patients who receive the same intervention but use the proposed system. There is a significant commercialization potential for the proposed technology due to 1) the size of the market, 2) the disruptive nature of our first-to-market technology, and 3) the ongoing national push for a transition from the current fee- for-service healthcare model to accountable-care-organization standards. We will have a market-ready device by the completion of Phase II with plans for a market launch during Phase III, pending FDA approval.

Public Health Relevance Statement:


Public Health Relevance:
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. We will develop wrist-worn sensors that encourage affected limb use during activities of daily living, remind patients to perform daily prescribed motor control exercises in the home environment, and assess the quality of limb movement during these exercises. This innovative therapeutic intervention will reduce socioeconomic and geographic disparities in rehabilitation outcomes by facilitating cost-effective in-home training.

Project Terms:
Acceleration; functional capacity; functional ability; daily living functionality; Activities of everyday life; Activities of Daily Living; Affect; Algorithms; Behavior; Biofeedback; Boston; Clinical Study; Clinical Research; Engineering; Exercise; Non-Trunk; Limbs; Extremities; Limb structure; Feedback; Geography; Goals; hemiparetic; hemiparesis; Hospitals; Interview; Laboratories; Living Wills; living will; Longitudinal Studies; long-term study; Motion; Motor Activity; Locomotor Activity; Movement; body movement; United States National Institutes of Health; National Institutes of Health; NIH; Neuronal Plasticity; neuroplasticity; neuroplastic; neural plasticity; CNS plasticity; New England; Northeastern United States; Occupational Therapy; Patients; Physical Medicine; Rehabilitation Medicine; Physiatry; Physiatrics; Rehabilitation therapy; rehabilitative; Rehabilitation; Medical Rehabilitation; Safety; stroke; cerebrovascular accident; cerebral vascular accident; brain attack; Cerebrovascular Stroke; Cerebrovascular Apoplexy; Cerebral Stroke; Brain Vascular Accident; Apoplexy; Technology; Testing; Time; Transportation; Wrist; Measures; Outcome Measure; Caring; base; dosage; sensor; improved; Chronic; Clinical; Phase; Training; Visual; Individual; Recovery; Bilateral; Fees for Service; Fee-for-Service Plans; Viewpoint; Editorial Comment; Commentary; Comment; Published Comment; Wolves; Nature; Life; Insurance Coverage; Insurance Status; programs; Scientist; Severities; Home environment; Home; System; Visit; equilibration disorder; impaired balance; equilibrium disorder; disturbed balance; balance impairment; balance disorder; field study; field test; field learning; field based data; limb movement; Performance; technology development; Rehabilitation Outcome; Health Insurance Portability and Accountability Act; United States Health Insurance Portability and Accountability Act; Public Law 104-191; PL104-191; PL 104-191; Kennedy Kassebaum Act; HIPAA; Categories; Devices; Biomedical Technology; Therapeutic Intervention; intervention therapy; Modeling; Intervention; interventional strategy; Intervention Strategies; Neuraxis; Central Nervous System; CNS Nervous System; Physical therapy; Physiotherapy; Physical Therapeutics; Physical Medicine Procedure; Physiatric Procedure; Provider; Upper Extremity; Upper Limb; Membrum superius; telehealth; Address; Data; Motor; Research Infrastructure; Infrastructure; Small Business Innovation Research; SBIR; Small Business Innovation Research Grant; STTR; Small Business Technology Transfer Research; wireless; Wireless Technology; Monitor; Process; socioeconomically; socio-economically; socio-economic; socioeconomics; developmental; Development; traditional therapy; website; web site; cost; telehealth systems; designing; design; cost effective; cost-effective; Upper limb movement; Consumption; innovation; innovative; innovate; Impairment; remote sensor; usability; constraint induced movement therapy; commercialization; motor control; telerehabilitation; telerehab; tele-rehabilitation; public health relevance; standard care; standard treatment; clinical practice; Secure; arm; motor function recovery; recovered motor function; arm movement; Accelerometer; activity tracker; activity monitor; accelerometry; exercise regimen; Exercise routine; improved outcome; health care service; healthcare service