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
基本信息
- 批准号:10546077
- 负责人:
- 金额:$ 25.66万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 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
项目摘要
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.
摘要
项目成果
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