Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking Performance and Quality of Life in Individuals With Multiple Sclerosis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Gait Velocity: Timed Walking
研究概览
简要总结
This study will seek to determine the benefits that FES-LE cycling has over cycling alone on walking performance and quality of life in people with multiple sclerosis.
详细描述
Functional Electrical Stimulation (FES) is a rehabilitation tool that stimulates nerves via electrical current, causing muscles to contract. When FES is appled to leg muscles during stationary cycling the legs move in a fixed rhythmical pattern. Previous studies have demonstrated that FES during cycling is a safe and effective exercise for individuals recovering from spinal cord injury or stroke, but few have applied this tool to a progressive disorder, such as multiple sclerosis (MS). The aim of this study is to assess the immediate and short-term effect of an 8-week training program comparing FES lower extremity cycling to cycling without FES. Twenty volunteers with MS will participate. They will be randomly assigned to a training group. This study examine the effects of training on quality of life, endurance, walking speed, and step quality. Participants will sign an informed consent and complete a questionnaire that includes medical history and demographic data. Before training, immediately after training finishes and one month after training, self-report questionnaires, timed walking tests will be completed. During the walking tests, step quality and speed will be measured with a sensor that is worn on a belt
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
- •Medical Diagnosis of MS
- •Patient-determined Disease Steps score between 3.0 and 6.0 inclusive
- •Ability to attend training sessions 3 times per week for an 8-10 week period
- •Passing a submaximal exercise test
- •Adequate hip range of motion (at least 110 degrees)
- •Adequate knee range of motion (10-90 degrees)
排除标准
- •Cognitive deficits that would interfere in ability to sign consent and understand the procedures for the study.
- •History or presence of other neurological pathologies that interfere with movement
- •Received physical therapy within the last 4 weeks prior to the study
- •History of an acute exacerbation of their MS symptoms within 4 weeks prior to the study
- •Immunosuppressive or steroid therapy within the past 4 weeks
- •Significant spasticity in the legs that interferes with the cycling motion
- •History of congestive heart failure
- •Coronary Artery Disease
- •Uncontrolled Hypertension
- •History of epilepsy or seizures
- •Cardiac demand pacemaker or implanted defibrillator
- •Unhealed fractures in the legs
- •Pressure sores or open wounds on the legs
- •Pregnant or trying to conceive
研究组 & 干预措施
FES Cycling
The intervention consists of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed).
干预措施: RT 300: Lower Extremity Cycling (Device)
Cycling Only
The intervention consists of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks. Electrical stimulation will not be applied to any muscles. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed.
干预措施: RT 300: Lower Extremity Cycling (Device)
结局指标
主要结局
Gait Velocity: Timed Walking
时间窗: 12 weeks
Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.
次要结局
- Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54(8 weeks)
- Self-reported Fatigue Using Modified Fatigue Impact Scale(8 weeks)
- Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale(8 weeks)
研究者
Lori Hochman
Clinical Assistant Professor
Stony Brook University