Rehabilitating Extremity Use After Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Motor Activity Log (MAL)
研究概览
简要总结
This study will compare two different kinds of physical therapy to improve use of the hands in individuals with multiple sclerosis (MS). One treatment will be Constraint-Induced Movement therapy (CI therapy), the other will be a set of Complementary and Alternative Medicine (CAM) treatments (yoga, relaxation exercises, aquatherapy, massage). The study will determine which of the two forms of treatment is more successful for improving hand use.
详细描述
Multiple Sclerosis (MS) frequently causes reduced use of one of the hands, and as a result, much of daily living activities are conducted only by the other hand, leaving the person effective one-handed. Nonetheless, reduced hand use can be improved for extended amounts of time with specific forms of physical therapy, as long as persons with MS have the ability to perform the training tasks.
This study will randomize persons with MS who have relatively reduced use of one of the hands to either CI therapy or CAM treatments. Treatment in either program will be for 2 consecutive weeks, 3.5 hours per day (Monday-Friday), under the direct supervision of a specially trained therapist. Before starting, participants will also undergo comprehensive medical and physical exam screening and brain MRI scan. The same evaluations will be performed after treatment to learn whether any of these have changed as a result of treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS)
- •reduced use of one of the hands because of MS
- •ability to pick up and release a small object with the more-affected hand when requested
- •can travel to the treatment program at the University of Alabama at Birmingham (UAB)
- •can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day
- •can undergo MRI scan
- •any kind of medication used for MS is allowed except spasticity medicine
排除标准
- •disease relapse in the past 3 months
- •pregnancy
- •marked pain with arm movement
- •severe uncontrolled medical illness
- •simultaneous treatment with another form of physical therapy
结局指标
主要结局
Motor Activity Log (MAL)
时间窗: Before treatment, and immediately, 6 months, and 12 months after the end of treatment.
The MAL is a structured interview on the amount and quality of the more-affected hand use during daily living activities.
次要结局
- Wolf Motor Function Test (WMFT)(Before treatment, and immediately, 6 months, and 12 months after the end of treatment.)
- MSFC (Multiple Sclerosis Composite Measure)(Before treatment, and immediately, 6 months, and 12 months after the end of treatment.)
- SARA (Scale for the Assessment and Rating of Ataxia)(Before treatment, and immediately, 6 months, and 12 months after the end of treatment.)
- EDSS (Expanded Disability Status Scale)(Before treatment, and immediately, 6 months, and 12 months after the end of treatment.)
- Fatigue Severity Scale (FSS)(Before treatment, and immediately, 6 months, and 12 months after the end of treatment.)
- MSIS-29 (Multiple Sclerosis Impact Scale)(Before treatment, and immediately, 6 months, and 12 months after the end of treatment.)
- MSSS-88 (Multiple Sclerosis Spasticity Scale)(Before treatment, and immediately, 6 months, and 12 months after the end of treatment.)
- Baecke Activity Questionnaire(Before treatment, and immediately, 6 months, and 12 months after the end of treatment.)
研究者
Victor W. Mark
Associate Professor
National Multiple Sclerosis Society