Developing and testing a comprehensive MS spasticity management program

开发和测试全面的多发性硬化症痉挛管理计划

• 批准号: 9000587
• 负责人: Lucinda L Hugos
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9000587
• 关键词: Activities of Daily Living; Address; Adverse effects; Affect; American; Area; Articular Range of Motion; Cardiovascular Diseases; Caring; Cessation of life; Clinical Practice Guideline; Communities; Companions; Contracture; Dependency; Development; Diagnosis; Disease; Education; Educational process of instructing; Effectiveness; Evidence based treatment; Exercise; Family; Fatigue; Female; Fibrosis; Film; Funding; Future; Gait abnormality; Grant Review; Guidelines; Hour; Infection; Institutional Review Boards; Instruction; Internet; Intervention; Investigation; Joints; Lead; Lower Extremity; Maintenance; Manuals; Mental Depression; Mission; Motor; Multiple Sclerosis; Muscle; Neuraxis; Neurologic Dysfunctions; Pain; Pamphlets; Participant; Patients; Performance; Pharmaceutical Preparations; Procedures; Publishing; Quality of life; Randomized; Recommendation; Recruitment Activity; Research Priority; Research Project Grants; Services; Skin; Sleep; Social isolation; Societies; Spasm; Stretching; Testing; Time; Veterans; Walking; Wheelchairs; Work; Writing; base; cost; disability; disabling disease; effective therapy; falls; health related quality of life; improved; male; nervous system disorder; novel; pilot trial; programs; public health relevance; social; treatment as usual; web site

DESCRIPTION (provided by applicant): The purpose of this project is to complete development of a comprehensive group education program on spasticity management for Veterans with MS-related spasticity and conduct a pilot trial of the program among Veterans with MS. Two important first steps towards development of the education program are complete. First, the Clinical Practice Guideline has been developed by multi-disciplinary MS experts. Second, the PI has produced a DVD MS Spasticity: Take Control targeted to people with MS and spasticity that highlights the key concepts of the Guideline. This DVD has been widely distributed on the websites of the VA MS Centers of Excellence and the Consortium of MS Centers. Three final pieces of a complete Guideline-based education program are missing. First, the cornerstone of treatment of MS-related spasticity is stretching to maintain full joint range of motion (ROM). All Guideline recommendations, treatments and procedures for MS spasticity throughout the lifetime of the disease, are predicated on a regular program of ROM/stretching for maintenance of ROM, optimal function and comfort. Presently no standardized and adequately described program exists for teaching people with MS how to do ROM/stretching. Second, a participant manual to reinforce all information and serve as reference material is yet to be developed. Third, the program needs to be tested for acceptance and efficacy before it can be widely utilized. Specific Aim 1: Create a DVD specifically to teach appropriate stretching of lower extremity muscles affected by MS-related spasticity that ambulatory Veterans with mild to moderate MS can independently follow and create written materials to reinforce information. We will select one male and one female Veteran with MS spasticity to demonstrate stretching exercises for filming and produce a DVD on stretching. We will write a participant manual as reference for participant review. Specific Aim 2: Perform a pilot trial of the complete education program with ambulatory Veterans with MS and lower extremity spasticity. In the second year, after obtaining IRB approval, we will recruit 20 Veterans with MS and spasticity to be randomized to one of two groups. One group will receive 'usual care' with a National MS Society (NMSS) distributed stretching booklet and instruction to stretch daily. The other group will receive the complete spasticity management program during 2 weekly 2-hour group sessions and instruction to continue daily stretching. This pilot will provide information on acceptability, feasibility and poer estimates for a larger study as a future RR&D Merit Review grant. We anticipate requiring 12 months to create the stretching DVD and companion written materials, the first specific aim. In the second year we will recruit subjects for the pilot of the complete program, deliver the program, analyze the results and submit for funding of a larger definitive trial assuming positive results from the initial investigation.

描述（由申请人提供）： 本项目的目的是完成一个全面的团体教育计划的痉挛管理与MS相关的痉挛退伍军人和进行试点试验的退伍军人与MS的两个重要的第一步教育计划的发展已经完成。首先，临床实践指南是由多学科MS专家开发的。第二，PI制作了一张DVD MS痉挛：针对MS和痉挛患者的控制，突出了指南的关键概念。这张DVD已经在VA MS卓越中心和MS中心联盟的网站上广泛分发。一个完整的基于指南的教育计划的最后三个部分缺失了。首先，治疗MS相关痉挛的基础是伸展以保持关节的完整活动范围（ROM）。在疾病的整个生命周期中，所有指南建议、治疗和MS痉挛的程序都是基于ROM/伸展的常规程序，以维持ROM、最佳功能和舒适度。目前还没有标准化和充分描述的程序存在教人与MS如何做ROM/拉伸。第二，尚未编制一份参与者手册，以加强所有信息并作为参考材料。第三，在广泛使用之前，需要对该计划进行接受度和有效性测试。具体目标1：创建一个DVD，专门教受MS相关痉挛影响的下肢肌肉的适当伸展，轻度至中度MS的非卧床退伍军人可以独立遵循并创建书面材料来加强信息。我们将挑选一男一女患有多发性硬化症的退伍军人示范伸展运动，并制作有关伸展运动的DVD。我们将编写一份参与者手册，供参与者参考。具体目标2：对患有MS和下肢痉挛的非卧床退伍军人进行完整教育计划的试点试验。第二年，在获得IRB批准后，我们将招募20名患有MS和痉挛的退伍军人，随机分为两组。其中一组将接受“常规护理”，国家多发性硬化症协会（NMSS）将分发伸展小册子和指导，每天伸展。另一组将接受完整的痉挛管理计划，每周2次，每次2小时，并指导继续每天拉伸。该试点将为更大规模的研究提供有关可接受性、可行性和功效估计的信息，作为未来的RR&D绩效审查补助金。我们预计需要12个月的时间来创建拉伸DVD和配套的书面材料，这是第一个具体目标。在第二年，我们将招募受试者进行完整项目的试点，交付项目，分析结果，并提交一个更大的确定性试验的资金，假设初步调查的结果是积极的。