Effects of Physical Therapy and Dalfampridine on Functional Mobility and Lower Extremity Strength in Non Ambulatory Persons With Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- MSQOL -54
研究概览
简要总结
The goal of this interventional double blind, randomized placebo controlled trial was to assess the change in functional mobility, quality of life and cognition for subjects who receive physical therapy and take dalfampridine vs those who receive physical therapy and take a placebo in non ambulatory persons with multiple sclerosis. The main question[s] it aims to answer are:
- Does the addition of dalfampridine to Physical Therapy improve functional outcomes compared to Physical Therapy alone
- Does Physical Therapy improve functional outcomes in patients who are non ambulatory
详细描述
This randomized control trial examined the effectiveness of dalfampridine when administered in conjunction with 12 weeks of physical therapy compared to physical therapy and a placebo on function, quality of life (QoL) and cognition in non-ambulatory pwMS.
Specific Aim 1: Assess the change in standing tolerance, transfers, repeated sit to stand, QoL and cognitive processing for non-ambulatory individuals with MS between subjects on Dalfampridine who receive physical therapy and those who participate in physical therapy and receive a placebo. Enhancing the propagation of action potentials along axons in addition to regularly contracting the muscles through exercise may have a greater effect on strength and functional mobility.
Specific Aim 2: Assess the functional, strength and cognitive changes within all subjects receiving PT 2x a week for 12 weeks. Evidence supporting the effectiveness of physical therapy in this population is extremely limited.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Subjects were blinded and randomized into 2 groups; Group 1 received physical therapy for 12 weeks while taking Dalfampradine 10 mg two times day and Group 2 received physical therapy while taking a placebo pill two times a day.
Both investigators that were preforming the testing and treatment were blinded as to subject group assignment.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years or older confirmed MS diagnosis
- •Expanded Disability Status Scale (EDSS) of 7.0 or higher
- •No steroid treatment in the last 30 days or a relapse in the last 90 days, and MS considered stable
- •Capable of performing requirements of Physical Therapy (PT) treatment including at least a 2/5 manual muscle test in 50% or more of the major muscle groups
排除标准
- •History of seizure disorder
- •Major cognitive or mental illness that prevented their ability to provide consent
- •Evidence of other medical cause of cognitive impairment besides MS
- •Severe joint contractures that limited the patients ability to move within full active range of motion
研究组 & 干预措施
Drug Group
干预措施: Dalfampridine Pill (Drug)
Placebo Group
干预措施: Placebo (Drug)
结局指标
主要结局
MSQOL -54
时间窗: 12 weeks
Five time Sit to Stand
时间窗: 12 weeks
次要结局
- Symbol Digit Modalities Test(12 weeks)
- Wheel chair to Mat transfers - Functional Independence Measure(12 weeks)
- Standing Tolerance(12 weeks)
- 9 Hole Peg Test(12 weeks)
研究者
Lacey Bromley
Project Manager
D'Youville College