Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
研究概览
简要总结
This study will examine the impacts of two different methods of managing MS-related spasticity of the lower limbs. Both interventions will be presented via video teleconference in group classes consisting of exercises to reduce spasticity.
详细描述
Now online since COVID-19
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •A diagnosis of definite MS by 2010 updated McDonald Criteria
- •Age 18 or older
- •Able to walk 25 feet with any assistive devices (Patient Determined Disease Steps 0-6)
- •Fluent in written and spoken English, as materials are not validated in languages other than English.
- •Presence of self-reported lower extremity spasticity that is interfering with daily activities or sleep, using the this definition: Have spasticity in your legs with unusual tightening of muscles that feels like leg stiffness, jumping of the legs, a repetitive bouncing of the foot, muscle cramping in the legs, or the legs going out tight and straight or drawing up.
- •All women that meet the above criteria
- •Only Veteran men that meet the above criteria
排除标准
- •Any uncontrolled medical or mental condition that would limit participation or completion of the study
- •Any self-reported musculoskeletal or neurological condition other than MS that is known to cause spasticity
研究组 & 干预措施
Spasticity Take Control
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
干预措施: Spasticity Take Control (Behavioral)
Stretching for People with MS: An Illustrated Manual
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
干预措施: Stretching for People with MS: An Illustrated Manual (Behavioral)
结局指标
主要结局
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
时间窗: One month post-intervention
Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
时间窗: Six months post-intervention
Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at six months post intervention. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
次要结局
- PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a(One month post-intervention)
- Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity(One month post-intervention)
- Fatigue, Measured by the Modified Fatigue Impact Scale(One month post-intervention)
- Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index(One month post-intervention)
- Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29)(One month post-intervention)
- Impact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12(One month post-intervention)
- Walking Measured by the Timed 25 Foot Walk(One month post-intervention)
- Walking and Turning Measured by the Timed Up and Go(One month post-intervention)