Clinical Assessment of a Massed Practice Therapy Device

大规模实践治疗装置的临床评估

• 批准号: 6934852
• 负责人: James B Koeneman
• 金额: $ 40.01万
• 依托单位: KINETIC MUSCLES, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-11-05 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6934852
• 关键词: biomedical equipment development; clinical research; clinical trials; computer assisted patient care; home health care; human subject; human therapy evaluation; medical rehabilitation related tag; patient oriented research; physical therapy; rehabilitation; robotics; stroke; stroke therapy; therapy design /development

DESCRIPTION (provided by applicant): This proposal addresses the need expressed in Program Announcement PA-02-071 to utilize innovative technologies to improve the physical and mental function of individuals with disabilities. Many stroke survivors have significant limitations of upper extremity function which have an impact on many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. However, costs often limit the number of patients that receive this type of therapy. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Phase I of this program demonstrated through laboratory testing and pilot clinical trials the feasibility of this innovative air muscle driven interactive device to provide effective and cost effective therapy. The primary aim of the proposed study is to determine in a randomized, controlled, single blind parallel clinical trial whether the use of this innovative biofeedback technology of Active Repetitive Motion (ARM) therapy in a home environment will increase function and improve the cognitive, emotional, and physical health of people with stroke and in this potentially cost effective manner. One hundred sub-acute (3 to 9 mos post stroke) patients will be randomized to a group that is trained on ARM device therapy and utilize it at home for 3 months or to a group with no ARM therapy. Both groups will receive usual and customary care. Clinical motor function and quality of life measures will compare the groups before intervention, immediatley after, and 3 months later. A subset will be evaluated 1 year later. We hypothesize that the ARM therapy group will improve more than the other group. Time spent using the device and the amount of usual and customary care received by each patient will be recorded, statistically analyzed and comparisons made. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project also has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

描述(由申请人提供)：本提案针对PA-02-071计划公告中表达的需要，利用创新技术改善残疾人的身体和心理功能。许多中风幸存者的上肢功能有明显的局限性，影响了许多重要的活动，如饮食、穿衣和个人护理。研究表明，为了有效地提高功能独立性，治疗必须包括患者的积极参与和重复训练。然而，费用往往限制了接受这种治疗的患者数量。机器人治疗提供了一种将一些基本但耗时的治疗转移到家里的方法。该计划的第一阶段通过实验室测试和试点临床试验证明了这种创新的空气肌肉驱动交互设备提供有效和成本效益高的治疗的可行性。这项拟议研究的主要目的是在一项随机、对照、单盲的平行临床试验中确定在家庭环境中使用这种创新的主动重复运动(ARM)治疗生物反馈技术是否会以这种潜在的成本效益的方式增加中风患者的功能并改善其认知、情绪和身体健康。100名亚急性(中风后3至9个月)患者将被随机分为接受手臂装置治疗并在家中使用3个月的组，或不接受手臂疗法的组。这两组人都将得到惯常和惯常的护理。临床运动功能和生活质量测评将在干预前、即刻、3个月后进行比较。子集将在1年后进行评估。我们假设手臂疗法组将比另一组改善更多。使用该设备的时间以及每个患者接受的日常护理和常规护理的数量将被记录下来，进行统计分析和比较。这一结果将为监测家庭治疗提供有效治疗的能力提供有价值的数据。该项目还有可能增加中风患者获得有效康复技术的可能性。