Clinical Trials in Stroke Rehabilitation

中风康复的临床试验

• 批准号: 7587256
• 负责人: John Chae
• 金额: $ 14.63万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-02 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7587256
• 关键词: Address; Area; Biomedical Engineering; Clinical Research; Clinical Trials; Cognitive; Commit; Dose; Double-Blind Method; Effectiveness; Electric Stimulation; Exhibits; Faculty; Fingers; Funding; Goals; Hand; Impairment; Injection of therapeutic agent; Intervention; Measures; Medicine; Mentors; Motor; Paralysed; Participant; Physicians; Placebo Control; Placebos; Principal Investigator; Process; Publications; Quality of life; Randomized Clinical Trials; Reaction Time; Rehabilitation therapy; Research Infrastructure; Research Personnel; Sensory; Shoulder Pain; Steroids; Stroke; Survivors; Testing; Training; Upper arm; Wrist; career; career development; compare effectiveness; experience; improved; meetings; neuromuscular; novel; patient oriented research; restoration; stroke rehabilitation

DESCRIPTION (provided by applicant): PROJECT SUMMARY: The candidate is a physiatrist-biomedical engineer with established funding and publication track record in patient oriented research (POR) in the area of functional electrical stimulation. His career development goal is to stimulate the field of Rehabilitation Medicine to build a critical mass of independent investigators to serve as principal investigators for clinical trials in stroke rehabilitation. The candidate's specific mentoring objectives are to 1) stimulate resident physicians to pursue a career in POR, and 2) equip and train junior faculty who are already committed to a career in POR to develop into independent investigators. These mentoring objectives will be met in the context of the training and research infrastructure provided by the General Clinical Research Center and the candidate's ongoing funded projects in 1) electrical stimulation for motor restoration in hemipleiga, 2) electrical stimulation for hemiplegic shoulder pain and 3) the proposed new project on the effectiveness of subacromial steroid injections for hemiplegic shoulder pain. The specific aims of the proposed new project are 1) to compare the effectiveness of subacromial steroid injection versus placebo in reducing hemiplegic shoulder pain and 2) to compare the effectiveness of standard versus high dose subacromial steroid injection in reducing hemiplegic shoulder pain. A placebo controlled, double-blinded, randomized clinical trial with 3 treatment arms (placebo, standard dose, high dose) will be conducted to address the specific aims. The project will develop new directions in POR for the candidate by providing him with the initial investigative experience with a non-electrical stimulation intervention so that he may contribute to a more comprehensive treatment approach to hemiplegic shoulder pain. RELEVANCE: There are over 4 million stroke survivors in the U.S. with over 700,000 new strokes occurring each year. Many stroke survivors exhibit severe paralysis and shoulder pain, both of which are associated significant activity limitations and reduced quality of life. However, the field of Rehabilitation Medicine is in dire need of clinician investigators who can develop and evaluate novel interventions that will reduce activity limitation, and improve societal participation and quality of life of these stroke survivors.

项目概述：该候选人是一名理疗师-生物医学工程师，在功能性电刺激领域的以患者为导向的研究（POR）方面有既定的资助和发表记录。他的职业发展目标是促进康复医学领域建立一批独立研究者，作为脑卒中康复临床试验的主要研究者。候选人的具体指导目标是1)激励住院医师追求POR的职业生涯，2)装备和培训已经致力于POR职业生涯的初级教师，使其发展成为独立的研究者。这些指导目标将在综合临床研究中心提供的培训和研究基础设施的背景下实现，以及候选人正在进行的资助项目：1)偏瘫运动恢复的电刺激，2)偏瘫肩痛的电刺激，以及3)拟议的关于肩峰下类固醇注射对偏瘫肩痛的有效性的新项目。提出的新项目的具体目的是：1)比较肩峰下类固醇注射与安慰剂在减轻偏瘫肩关节疼痛方面的有效性；2)比较标准剂量与高剂量肩峰下类固醇注射在减轻偏瘫肩关节疼痛方面的有效性。为了达到特定目的，将进行安慰剂对照、双盲、随机临床试验，共有3个治疗组（安慰剂、标准剂量、高剂量）。该项目将为候选人提供非电刺激干预的初步调查经验，从而为偏瘫肩痛的更全面治疗方法做出贡献，从而为POR发展新的方向。相关性：在美国有超过400万的中风幸存者，每年有超过70万的新中风发生。许多中风幸存者表现出严重的瘫痪和肩部疼痛，这两种情况都与严重的活动限制和生活质量下降有关。然而，康复医学领域迫切需要能够开发和评估新的干预措施的临床研究人员，这些干预措施将减少活动限制，提高这些中风幸存者的社会参与和生活质量。