Developing and Testing a Comprehensive MS Spasticity Management Program
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- MS Walking Scale-12 (MSWS-12)
研究概览
简要总结
This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.
详细描述
Participants have 2-4 visits depending on program assignment. All participants will have screening/baseline and follow-up visits. Participants in the intervention program will have 2 additional visits with a group of other people with MS to view and discuss the DVDs on spasticity education and stretching for lower extremity MS spasticity and then practice the stretching exercises learned. They will be asked to track exercise electronically and on paper for 4 weeks. Participants will be compensated for participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of definite MS
- •At least 18 years old
- •Able to walk 25 feet independently with common assistive devices if needed
- •Presence of spasticity by self-report interfering with usual daily activities
- •Have an email account and be familiar with using it
- •Willing to track daily exercise for 4 weeks
- •Fluent in English
排除标准
- •Other medical or behavioral conditions that would limit participation or completion of the study.
研究组 & 干预措施
A Spasticity: Take Control
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
干预措施: Spasticity: Take Control (Behavioral)
B Usual care
2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
干预措施: Usual care (Other)
结局指标
主要结局
MS Walking Scale-12 (MSWS-12)
时间窗: at average of 4 months
The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time. Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability.
次要结局
- Timed 25 Foot Walk(at average of 4 months)
- Timed up and go Test(at average of 4 months)
- 2 Minute Walk Test(at average of 4 months)
- Modified Fatigue Impact Scale (MFIS)(at average of 4 months)
- Multiple Sclerosis Impact Scale (MSIS-29)(at average of 4 months)
- Spasticity Measured by the Modified Ashworth Scale(at average of 4 months)
- Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)(at average of 4 months)
- Beck Depression Inventory II (BDI II)(at average of 4 months)