CI Therapy and Novel Virtual Environments

描述（由申请人提供）：本I期试验的目的是确定通过单独使用新型计算机生成的虚拟场景（VS）和强制诱导治疗（CIT）方案进行卒中康复获得的康复效果。VS和/或VS增强CIT（VS-CIT）治疗方案的有效结果可以通过增强恢复对中风幸存者的生活产生积极影响。我们通过第一阶段STTR提案寻求验证的技术可以应用于针对中风受害者康复的产品，并可能减轻中风相关残疾估计每年超过510亿美元的负担。未来的目标包括确定该技术是否可以开发成供不同原因和类型的残疾人使用的产品。 该STTR提案有3个具体目标（SA）：1）确定VS和/或VS-CIT是否具有治疗效果。2)建立II期随机临床试验（RCT）的可行性，以评估VS单独和联合VS-CIT方案的疗效。3)在II期RCT中微调VS和VS-CIT的实验设计和干预程序。SA 1）我们将评估VS和VS-CIT疗程（每次三周）导致的a）伸手和抓握动作、B）上肢损伤、c）功能和d）残疾的表现变化。在患有中风的人中，分别使用a）Winstein实验室最近开发的具有行为运动学的伸手抓握灵巧性指数，B）损伤的标准化临床测试（Fugl-Meyer），c）功能（偏瘫上肢功能测试），和d）残疾（中风影响量表）。SA 2）为II期临床试验制定VS技术的实际要求。SA 3）评估患者对VS和VS-CIT程序的满意度，并使用经验证的问卷评估手臂使用的自我效能。第二阶段将在临床环境中建立更广泛的应用，纳入患者的观点和长期结果。

DESCRIPTION (provided by applicant): The goal of this Phase I trial is to determine the rehabilitative effects gained through the use of a novel computer generated virtual scenario (VS), alone and with a protocol of constraint-induced therapy (CIT), for stroke rehabilitation. Efficacious results of a therapeutic protocol of VS and/or VS enhanced CIT (VS-CIT) could positively impact the lives of stroke survivors through enhanced recovery. The technology we seek to verify through this Phase I STTR proposal could be applied to products directed toward the rehabilitation of stroke victims and perhaps lessen the over 51 billion dollar estimated annual burden from stroke-related disability. Future goals involve determining whether the technology could be developed into products to be used by individuals with disabilities of different causes and types. This STTR proposal has 3 specific aims (SA): 1) Determine if there is a therapeutic effect of VS and/or VS-CIT. 2) Establish the feasibility of a Phase II randomized clinical trial (RCT) to evaluate the efficacy of VS alone and a combined VS-CIT protocol. 3) Fine tune the experimental design and intervention procedures for VS and VS-CIT in a Phase II RCT. These will be achieved as follows: SA 1) We will assess change in performance of a) reaching and grasping actions, b) upper extremity impairment, c) function, and d) disability, resulting from VS and VS-CIT sessions (three weeks ea.) in persons who have sustained a stroke and using an a) index of reach-grasp dexterity with behavioral kinematics recently developed in the Winstein lab, b) a standardized clinical test of impairment (Fugl-Meyer), c) function (Functional Test of the Hemiparetic Upper Extremity), and d) disability (Stroke Impact Scale), respectively. SA 2) Develop practical requirements of the VS technology for a Phase II clinical trial. SA 3) Assess patient satisfaction with the program of VS and VS-CIT and evaluate self-efficacy of arm use with a validated questionnaire. Phase II will establish a broader application in the clinical environment, incorporate patient perspectives, and longer-term outcomes.