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: 7065285
• 负责人: James B Koeneman
• 金额: $ 39.06万
• 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/7065285
• 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）：本提案解决了计划公告PA-02-071中表达的利用创新技术改善残疾人身心功能的需求。许多中风幸存者上肢功能明显受限，影响了许多重要活动，如进食、穿衣和个人护理。研究表明，为了有效地提高功能独立性，治疗必须涉及患者的积极参与和重复训练。然而，成本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这种必要但耗时的治疗转移到家中的方法。该项目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式设备的可行性，以提供有效和具有成本效益的治疗。拟议研究的主要目的是在一项随机、对照、单盲平行临床试验中确定在家庭环境中使用主动重复运动（ARM）治疗的这种创新生物反馈技术是否会以这种潜在的成本效益方式增加中风患者的功能并改善其认知、情感和身体健康。将100例亚急性（卒中后3 - 9个月）患者随机分配至接受ARM器械治疗培训并在家使用3个月的组或未接受ARM治疗的组。两组都将接受常规和常规护理。临床运动功能和生活质量指标将在干预前、干预后即刻和3个月后对各组进行比较。一个子集将在1年后进行评价。我们假设ARM治疗组的改善程度比另一组更大。将记录每例患者使用器械所花费的时间以及接受的常规护理量，并进行统计分析和比较。这些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。该项目也有可能增加中风患者有效康复技术的可用性。