Development of a Multifunctional Rehabilitation Standing and Stepping Device for Persons with Parkinson's Disease

帕金森病患者多功能康复站立踏步器的研制

• 批准号: 10546077
• 负责人: Nicolaas Bohnen
• 金额: $ 25.66万
• 依托单位: TULIP MAKE ME MOVE DESK, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10546077
• 关键词: Activities of Daily Living; Alzheimer' s Disease; Anterior; Attention; Biofeedback; Clinical; Clinical Trials; Cognition; Cognitive; Communities; Complex; Control Groups; Controlled Clinical Trials; Data; Development; Device Approval; Devices; Effectiveness; Elderly; Environment; Equilibrium; Exercise; Feedback; Gait; Goals; Head; Home; Home environment; Hour; Human; Impaired cognition; Impairment; Insurance Carriers; Medical; Medical Device; Medicare; Metabolic; Metabolic syndrome; Michigan; Modeling; Morbidity - disease rate; Motor; Movement; Muscle; Parkinson Disease; Patients; Pattern; Performance; Persons; Phase; Physical activity; Physical therapy; Posture; Prevalence; Protocols documentation; Quality of life; Randomized; Rehabilitation device; Rehabilitation therapy; Reporting; Risk; Rotation; Small Business Technology Transfer Research; Speed; Supervision; Symptoms; Syndrome; System; Target Populations; Testing; Therapeutic; Therapeutic Uses; Universities; Work; base; clinical practice; clinically relevant; cognitive ability; commercialization; comorbidity; compliance behavior; conditioning; cost; cost effective; dementia risk; design; frailty; improved; improved mobility; individualized medicine; intervention cost; motor rehabilitation; next generation; novel; patient population; performance tests; phase 2 study; programs; prototype; rehabilitation service; research and development; safety and feasibility; sarcopenia; targeted treatment; trial comparing; usual care arm

ABSTRACT Tulip Make Me Move Desk, LLC is a startup medical device company based on R&D of the Multifunctional Rehabilitation Standing & Stepping Device (MRSSD) prototype. The MRSSD is a standing desk with a multidirectional moving tabletop that induces stepping movements while standing and simultaneously performing motor and cognitive activities behind it. The MRSSD can serve as a stand-alone rehabilitation device or as an adjunct to (physical therapy) PT. A prior very basic prototype of the MRSSD, called the “dynamic standing desk” (DSK), has shown clinical feasibility of in-home use in persons with Parkinson's disease (PwP) showing an average 2-hr daily use that was sustained over a 4-month period. Importantly, post-PT improvements in gait and balance fucntions were sustained over this period while lost in a usual care control group. Movement of the DSK , however, was limited to fixed speed and mediolateral excursions only. This precludes individualized therapeutic use that is needed for the highly variable range of impairments in gait, balance, cognition, sarcopenia, and common medical comorbidities, such as metabolic or vestibular changes and sarcopenia, seen in PwP. Therefore, there is a need for symptom-specific rehabilitation goals in PwP that is also low cost, barrier-free and unlike intermittent PT can be sustained in the long-term. We propose to develop a multifunctional rehabilitation device that allows individualized targeting of specific morbidities in PwP, such as imbalance (emphasis on mediolateral excursions), gait turning (emphasis on rotatory excursions), metabolic syndrome and sarcopenia (emphasis on higher intensity and large excursions), vestibular changes (emphasis on anterior-posterior and rotatory excursions), and cognitive impairment (emphasis on cognitive-motor dual tasking desktop activities). Therefore, the MRSSD has the potential to provide a multifunctional, barrier-free, sustainable and low-cost intervention to improve gait, balance, medical comorbidities and maintain cognition in PwP, who are at risk of dementia, including comorbid Alzheimer’s disease. The MRSSD rehabilitation device will also fill a therapeutic void by providing a rehabilitation standing desk that can uniquely integrate individualized multidirectional stepping therapy with routine activities of daily living in the home environment thereby enabling long-term sustained utilization rates. The goals of this STTR proposal are (i) to develop a next-generation MRSSD multidirectional and variable range and intensity mobility, metabolic and cognitive-motor rehabilitation therapy device, (ii) collect user acceptance and in-lab feasibility of repeated use data & (iii) conduct a pilot controlled clinical trial to generate data to power a large-scale clinical trial in Phase II. The long-term goal of this STTR is to provide a cost-effective, easy to implement a sustainable multi-purpose rehabilitation option for patient populations with mobility, metabolic and cognitive impairments.

摘要