Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Walking Endurance
研究概览
简要总结
The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.
详细描述
Participants will be randomly assigned to one of two study arms. Those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a Vectra Genisys System.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read, understand, and speak English to ensure safe participation in the project
- •Difficulties with walking
- •On stable doses of Ampyra, provigil, or other symptomatic-treating medications
- •No systemic steroids within the last 30 days
- •Not currently exercising more than 2x/wk
- •Able to arrange own transportation to and from the laboratories
- •Provide informed consent, including willingness to be randomly assigned to one of the two groups
排除标准
- •Documented MS-related relapse in the last 3 months
- •Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
- •Poorly controlled diabetes mellitus or hypertension
- •History of seizure disorders
- •Alcohol dependence or abuse (≥2 drinks/day), or present history (last 6 months) of drug abuse
- •Inability to attend exercise sessions 3 days per week for 6 weeks
结局指标
主要结局
Walking Endurance
时间窗: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Distance walked in 6 min
Modified Fatigue Impact Scale
时间窗: Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.
次要结局
- Maximal Walking Speed(Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).)
研究者
Roger Enoka
Professor
University of Colorado, Boulder