Evaluation of a Spasticity Management Program for People with Multiple Sclerosis

这个建议的目的是评估一个新的多发性硬化症（MS）痉挛教育和伸展 一项名为MS Spasticity：Take Control（STC）的项目，在一项完全有效的随机对照试验中获益 在一个月（短期）的家庭伸展练习和六个月（中期）后的好处的可持续性 #21453;家的实践。完成重要的第一步：1）痉挛和MS临床实践 已经制定了指导方针; 2）拟议的PI已经为MS创建了一个自我管理程序STC- 相关痉挛，包括两个DVD MS痉挛：采取控制（与教育信息）和MS 痉挛：控制下肢伸展（标准化伸展说明）， 同伴参考手册，和3）该计划已在40名受试者与MS和痉挛。STC 证实了初步疗效以及可行性、可接受性和快速入组，并报告了满意度 参与者。在本研究中，俄勒冈州西北部和华盛顿西南部的合格受试者将 1：1随机分配至STC或常规护理（UC）。STC受试者将参加两个面对面的小组会议， PI和研究协调员在第一次会议上查看和讨论两个DVD中提供的信息 并在第二阶段练习所有的伸展动作，目的是找到一套日常练习。 为接下来六个月的家庭训练做准备UC受试者将不上课，而是， 将得到一份NMSS拉伸小册子的副本，用于他们的家庭实践，而无需指导或小组 支持. STC组的主要终点结局指标将在课程结束后收集， 一个月的家庭实践。在6个月的家庭练习后，将收集相同的结果测量结果， 受试者退出研究的次要终点。两个小组将在两周内开始他们的家庭练习。 在两个月内收集基线数据，并提供相同的日记进行跟踪 他们的家庭伸展和其他锻炼参与。主要结局指标是MS痉挛 第八十八章.次要结果指标是痉挛状态数字评定量表和国家研究所 美国卫生部（NIH）患者报告结局测量信息系统（PROMIS）收集， 具体评估疲劳、睡眠、身体功能、自我效能、社会参与、社会满意度， 从他们在线收集的患者报告的健康状况清单中了解全球健康状况， 结果测量与管理计算机化的适应性测试（CAT）的新能力。CAT适应 根据参与者先前的回答选择后续问题， 因此，每个测试大约需要一到两分钟才能完成。NIH建议 使用这些结果指标，通过使研究更容易比较来加速发现。一个新 包括下肢伸展在内的MS痉挛的标准化程序现已存在，具有可行性， 初步疗效和需要在充分把握度试验中进行短期和中期获益测试。如果有效， 预计治疗将影响日常功能，加强与家庭的参与， 社区和改善健康相关的生活质量的所有人与MS和痉挛。基于web的 干预措施可以从目前的计划中创建，以便在整个VA中传播，如果有效， 可以适应其他神经系统疾病与痉挛，如脊髓损伤，脑外伤， 并且容易在世界范围内传播。我们预计在48个月内招募受试者， 俄勒冈州和华盛顿，提供干预，跟踪他们6个月，报告结果并提交 STC的未来试验或基于网络的程序版本的开发。

The purpose of this proposal is to evaluate a new multiple sclerosis (MS) spasticity education and stretching program called MS Spasticity: Take Control (STC) in a fully powered, randomized, controlled trial for benefit after one month (short-term) of home stretching practice and sustainability of benefit after six months (medium- term) of home stretching practice. Important first steps are complete: 1) the Spasticity and MS Clinical Practice Guideline has been developed; 2) the proposed PI has created a self-management program, STC, for MS- related spasticity that includes two DVDs MS Spasticity: Take Control (with educational information) and MS Spasticity: Take Control of Lower Extremity Stretching (with standardized stretching instructions) and companion reference manuals, and 3) the program has been tested in 40 subjects with MS and spasticity. STC demonstrated initial efficacy as well as feasibility, acceptance and rapid enrollment with satisfaction reported by participants. In the present study, eligible subjects in northwest Oregon and southwest Washington will be randomly assigned 1:1 to STC or usual care (UC). STC subjects will attend two in-person group sessions with the PI and the study coordinator to view and discuss information presented in both DVDs at the first session and practice all the stretches in the second session with the goal of finding a set of exercises for daily stretching for their home practice for the following six months. UC subjects will not attend classes but, instead, will be given a copy of the NMSS stretching brochure to use in their home practice without instruction or group support. The primary endpoint outcome measures will be collected after the classes for the STC group and one month of home practice. The same outcome measures will be collected after six months of home practice for the secondary endpoint when subjects will exit the study. Both groups will start their home practice within two weeks of each other, within two months of baseline data collection and be provided the same diaries to track their home stretching and other exercise participation. The primary outcome measure is the MS Spasticity Scale 88. Secondary outcome measures are the Numeric Rating Scale for Spasticity and the National Institute of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) collection that specifically assess fatigue, sleep, physical function, self-efficacy, social participation, social satisfaction and perception of global health from their online collection of patient-reported health status inventories and outcome measures with the novel capability of administering computerized adaptive tests (CATs). CATs adapt to the individual by selecting subsequent questions based on participants’ prior responses reducing the length of the tests and therefore each test takes approximately one to two minutes to complete. The NIH recommends using these outcome measures to accelerate discovery by making studies more easily comparable. A new standardized program for MS spasticity including lower extremity stretching now exists, has feasibility and initial efficacy and needs testing in a fully powered trial for short and medium term benefit. If effective, such treatment would be expected to impact the day-to-day function, enhance participation with families and the community and improve health related quality of life for all people with MS and spasticity. A web-based intervention could be created from the current program for dissemination throughout the VA and, if effective, could be adapted to other neurological conditions with spasticity such as spinal cord injury, traumatic brain injury and stroke and also easily disseminated worldwide. We anticipate 48 months to recruit subjects in Oregon and Washington, deliver the intervention, follow them for 6 months, report the results and submit for a future trial of STC or development of a web-based version of the program.