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Boost: A pragmatic inpatient rehabilitation strategy for improving musculoskeletal arm recovery after stroke

Boost：一种实用的住院康复策略，可改善中风后手臂肌肉骨骼的恢复

基本信息

批准号：
10490452
负责人：
Daniel Zondervan
金额：
$ 83.57万
依托单位：
FLINT REHABILITATION DEVICES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-21 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10490452
关键词：
Analysis of Covariance Biomechanics Chronic Clinical Cognitive Control Groups Devices Educational process of instructing Elbow Exercise Feedback Healthcare Home Hour Impairment In Situ Individual Inpatients Leg Life Living Standards Manual wheelchair Modeling Motor Movement Muscle Musculoskeletal Nervous System Trauma Outcome Measure Pain Pamphlets Participant Pathway interactions Patients Pattern Persons Phase Production Public Health Randomized Randomized Controlled Trials Recovery Rehabilitation therapy Research Rest Robotics Safety Self Care Sensory Shoulder Small Business Innovation Research Grant Societies Sterile coverings Stroke Supervision System Techniques Technology Testing Time Upper Extremity Wheelchair propulsion Wheelchairs arm arm paresis base clinical efficacy clinical practice commercialization conventional therapy daily functioning design disability experimental study follow-up improved innovation manufacturability motor deficit motor impairment motor recovery movement practice novel pilot test post stroke primary outcome prototype rehabilitation strategy routine practice spasticity stroke recovery success synergism tool user centered design

项目摘要

One in six people will have a stroke; over half will incur chronic upper extremity (UE) impairment. While intensive rehabilitation reduces impairment, most individuals do not perform enough movement practice early after stroke when plasticity is heightened. Our hypothesis is that there is a threshold level of UE motor drive needed to provoke true UE recovery, yet individuals do not routinely exceed this threshold during inpatient rehabilitation. To solve this, Flint Rehab and UC Irvine propose to test a novel, pragmatic rehabilitation strategy for enabling individuals with even severe arm impairment to increase UE motor drive early after stroke. We will leverage a ubiquitous piece of technology–the manual wheelchair–based on two key observations. The first is a pivotal study by Feys et al. that had 100 inpatients with subacute stroke rock themselves in rocking chairs by repetitively reaching forward with their impaired arm 500- 1000 times per day; these patients had significantly greater increases in UE Fugl-Meyer (FM) score of 17 points at a five-year follow up compared to control. This is a remarkable effect, yet this therapy remains unimplemented in routine clinical practice. A second observation: 70% of stroke inpatients (and nearly all with more severe impairments) spend several hours each day sitting passively in manual wheelchairs, often with their paretic arm strapped into an arm trough. Further, when they move in their wheelchair, they are pushed, or taught to use their “good” arm and leg. Our core idea is to use a novel, moveable wheelchair armrest called Boost to enable inpatients to perform the repetitive arm therapy validated by Feys while seated in their wheelchair. Boost quickly clicks into a wheelchair frame just like a conventional wheelchair armrest and incorporates an innovative linear mechanism that enables UE activation in two modes: 1) with the chair remaining stationary, or 2) with the user contributing to propelling their wheelchair with their impaired arm. This latter mode transforms the "good arm + good leg" compensatory wheelchair propulsion technique into “good arm + good leg + impaired arm” propulsion. We hypothesize that use of Boost during inpatient therapy will enable individuals with stroke to achieve the threshold level of UE motor drive required to provoke UE recovery in routine practice, significantly improving recovery compared to conventional treatment. We have already pilot tested a functional prototype of Boost with positive results. Thus, for this Direct-to-Phase II SBIR our aims are to: Aim 1) Develop a commercial-ready model of Boost with clinical and end-user feedback; Aim 2) Perform a randomized controlled trial of Boost with inpatients with subacute stroke (N=58). At project end, we will have validated the clinical feasibility and efficacy of Boost and optimized it for production and mass distribution. If our plan is successful, we will have demonstrated that wheelchair-based “rocking therapy” can help patients routinely achieve the threshold level of sensory motor drive needed to provoke true UE recovery.

六分之一的人会中风;超过一半的人会出现慢性上肢（UE）损伤。而强化康复可以减少损伤，大多数人没有进行足够的运动练习在中风后早期可塑性增强。我们的假设是，存在UE的阈值水平运动驱动需要激发真正的UE恢复，但个体通常不会超过这个阈值在住院康复期间为了解决这个问题，弗林特康复中心和加州大学欧文分校提出测试一种新颖，务实的康复策略，使即使是严重的手臂损伤的人，以增加UE运动中风后尽早开车。我们将利用一项无处不在的技术-手动轮椅为基础的两个关键的观察。第一项是Feys等人的关键性研究，有100名亚急性胰腺炎住院患者，中风患者通过用他们受损的手臂重复地向前伸出而在摇椅中摇动他们自己500- 1000次/天;这些患者的UE Fugl-Meyer（FM）评分显著增加17 与对照组相比，5年随访时的分数。这是一个显着的效果，但这种疗法仍然存在在常规临床实践中未实施。第二个观察结果：70%的中风住院患者（几乎所有有更严重损伤的人）每天被动地坐在手动轮椅上几个小时，经常把他们瘫痪的手臂绑在手臂槽里。此外，当他们在轮椅上移动时，他们被迫或被教导使用他们的“好”胳膊和腿。我们的核心理念是用一种新颖的，可移动的一种名为Boost的轮椅扶手，使住院患者能够进行重复的手臂治疗，费斯坐在轮椅上。Boost快速点击进入轮椅框架，就像传统的轮椅扶手，并采用了创新的线性机制，使UE激活在两个模式：1）椅子保持静止，或2）用户有助于推动他们的轮椅与他们受损的手臂。这后一种模式将“好胳膊+好腿”的补偿将轮椅推进技术转化为“好臂+好腿+受损臂”推进。我们假设在住院治疗期间使用Boost将使中风患者达到阈值在常规实践中，引起UE恢复所需的UE运动驱动水平，显著改善与常规治疗相比，我们已经试验了一个功能原型，以积极的结果推动。因此，对于这个直接进入第二阶段的SBIR，我们的目标是：目标1）开发一个具有临床和最终用户反馈的Boost的商业就绪模型;目的2）执行随机化 Boost在亚急性卒中住院患者中的对照试验（N=58）。在项目结束时，我们将有验证了Boost的临床可行性和有效性，并优化了其生产和大规模分销。如果我们的计划成功，我们将证明基于轮椅的“摇摆疗法”可以帮助患者通常达到引起真正UE恢复所需的感觉运动驱动阈值水平。