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 Tulip Make Me Move Desk，LLC是一家基于多功能医疗器械研发的初创医疗器械公司。 康复站立和踏步设备（MRSSD）原型。MRSSD是一个站立式办公桌， 多方向移动桌面，其在站立时引起步进运动并同时执行 运动和认知活动。MRSSD可以作为一个独立的康复设备或作为一个 辅助（物理治疗）PT。MRSSD之前的一个非常基本的原型，称为“动态站立办公桌”， (DSK)，已经显示了帕金森病（PwP）患者在家中使用的临床可行性， 平均每天使用2小时，持续4个月。重要的是，PT后步态改善， 平衡功能在此期间得以维持，而在常规护理对照组中则丧失。DSK的运动 然而，仅限于固定速度和中外侧偏移。这就排除了个体化治疗 用于步态、平衡、认知、肌肉减少症和 常见的医学合并症，如代谢或前庭变化和肌肉减少症，见于PwP。 因此，需要在PwP中制定针对残疾人的康复目标，这些目标也是低成本、无障碍和 不像间歇性PT可以长期持续。我们建议开发一种多功能康复 允许个性化针对PwP中特定发病率的器械，例如失衡（强调 中外侧偏移）、步态转向（强调旋转偏移）、代谢综合征和肌肉减少症 （强调更高的强度和大的偏移），前庭变化（强调前后和 旋转偏移）和认知障碍（强调认知-运动双重任务桌面活动）。 因此，MRSSD具有提供多功能，无障碍，可持续和低成本的潜力 干预，以改善步态，平衡，医疗合并症和维持认知的PwP，谁是风险 痴呆症，包括共病阿尔茨海默病。MRSSD康复设备也将填补一个治疗 通过提供一种康复站立桌，可以独特地整合个性化的多方位 在家庭环境中进行日常生活的日常活动的步进治疗， 可持续利用率。该STTR提案的目标是：（i）开发下一代MRSSD 多向和可变范围和强度的活动、代谢和认知运动康复 治疗设备，（ii）收集用户接受度和重复使用数据的实验室可行性，以及（iii）进行 中试对照临床试验，以生成数据，为II期大规模临床试验提供动力。长期 本STTR的目标是提供一个具有成本效益，易于实施的可持续多用途康复 适合有行动能力、代谢和认知障碍的患者人群。