Development of a Multifunctional Rehabilitation Standing and Stepping Device for Persons with Parkinson's Disease
Development of a Multifunctional Rehabilitation Standing and Stepping Device for Persons with Parkinson's Disease
批准号:
10546077
负责人:
Nicolaas Bohnen
金额:
$25.66万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-09-15 至 2023-12-31
关键词:
Activities of Daily LivingAlzheimer&aposs DiseaseAnteriorAttentionBiofeedbackClinicalClinical TrialsCognitionCognitiveCommunitiesComplexControl GroupsControlled Clinical TrialsDataDevelopmentDevice ApprovalDevicesEffectivenessElderlyEnvironmentEquilibriumExerciseFeedbackGaitGoalsHeadHomeHome environmentHourHumanImpaired cognitionImpairmentInsurance CarriersMedicalMedical DeviceMedicareMetabolicMetabolic syndromeMichiganModelingMorbidity - disease rateMotorMovementMuscleParkinson DiseasePatientsPatternPerformancePersonsPhasePhysical activityPhysical therapyPosturePrevalenceProtocols documentationQuality of lifeRandomizedRehabilitation deviceRehabilitation therapyReportingRiskRotationSmall Business Technology Transfer ResearchSpeedSupervisionSymptomsSyndromeSystemTarget PopulationsTestingTherapeuticTherapeutic UsesUniversitiesWorkbaseclinical practiceclinically relevantcognitive abilitycommercializationcomorbiditycompliance behaviorconditioningcostcost effectivedementia riskdesignfrailtyimprovedimproved mobilityindividualized medicineintervention costmotor rehabilitationnext generationnovelpatient populationperformance testsphase 2 studyprogramsprototyperehabilitation serviceresearch and developmentsafety and feasibilitysarcopeniatargeted treatmenttrial comparingusual care arm
中文摘要
摘要
郁金香Make Me Move Desk,LLC是一家基于多功能研发的初创医疗设备公司
康复站立步进器(MRSSD)样机。MRSSD是一种立式办公桌,带有
多向移动的桌面,在站立和同时表演时诱导步进运动
它背后的运动和认知活动。MRSSD可以作为独立的康复设备或作为
(物理疗法)的辅助者。此前,MRSSD的一个非常基本的原型,称为“动态站立式办公桌”
(Dsk),已经证明了家庭使用帕金森氏病(PWP)的临床可行性,显示出
平均每天使用2小时,持续4个月。重要的是,术后步态和
在此期间,平衡功能得以维持,而在常规护理对照组中,平衡功能丧失。卡斯特罗的动向
然而,仅限于固定速度和内侧偏航。这就排除了个体化治疗
在步态、平衡、认知、骨质疏松症和
常见的内科合并症,如代谢或前庭改变和骨质疏松症,见于PWP。
因此,有必要在PWP中设定针对症状的康复目标,同时也是低成本、无障碍和
与间歇性PT不同,PT可以长期持续。我们建议开发一种多功能康复
一种设备,允许针对PWP中的特定疾病进行个性化定位,例如失衡(重点是
内侧远足)、步态转向(强调旋转远足)、代谢综合征和骨质疏松症
(强调更高强度和大范围的偏移),前庭变化(强调前后部和
旋转远足)和认知障碍(强调认知-运动双重任务桌面活动)。
因此,MRSSD有潜力提供一种多功能、无障碍、可持续和低成本的
改善PWP患者步态、平衡、医学合并症和维持认知的干预措施
痴呆症,包括共病的阿尔茨海默氏症。MRSSD康复设备还将填补治疗
通过提供可独一无二地整合个性化多方向的康复站立式办公桌来实现空虚
在家庭环境中进行日常生活活动的步进式治疗,从而使长期的
持续的利用率。该STTR提案的目标是(I)开发下一代MRSSD
多方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)收集重复使用的用户接受度和实验室内的可行性数据&(Iii)进行
试点对照临床试验以产生数据,为第二阶段的大规模临床试验提供动力。长期
本STTR的目标是提供一种经济有效、易于实施的可持续的多用途康复
为行动不便、代谢和认知障碍的患者群体提供选择。
英文摘要
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.
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