Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Gait Speed
研究概览
简要总结
The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.
详细描述
The study will involve a randomized, double-blind, controlled trial. Randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (A or B) of the person who contacted the investigators first. The participants and outcome assessors will be blinded to group assignment. Both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. Participants will be evaluated at weeks 0, 4, 8, and 12.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read, write, and speak English to ensure safe participation in the project
- •Clinical diagnosis of multiple sclerosis
- •Mild-to-moderate level of disability
- •On stable doses of symptom-treating medications
- •No MS exacerbations within the last 30 day
- •Healthy enough to complete the protocol as indicated by the absence of a medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in tests that involve electrical nerve stimulation (e.g., not implanted devices or internal metal)
- •Able to arrange own transportation to Boulder campus
排除标准
- •Documented MS-related relapse within the last 30 days
- •Medical diagnosis or condition that is considered to be a contraindication to participating in the intervention, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than basal cell cancer), other neurological disorders, or pregnancy.
- •Vestibular disorder
- •Musculoskeletal disorder
- •History of seizure disorders
- •>2 alcoholic drinks/day,or present history (last 6 months) of drug abuse
- •Spasticity that requires the individual to change an activity more than once a week
- •Skin disease or sensation problems in the legs or hands that influence some activities more than once a week
- •Claustrophobia
- •Metallic implants
- •Inability to attend treatment sessions 3 days per week for 6 weeks
结局指标
主要结局
Change in Gait Speed
时间窗: Change from baseline at weeks 4, 8, and 12.
Time to walk 25 ft as quickly as possible
Change in Dynamic Balance
时间窗: Change from baseline at weeks 4, 8, and 12
Score achieved on the four components of the 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest). The maximum score for each subscale are: anticipatory = 6, reactive postural control = 6, sensory orientation = 6, dynamic gait = 10. The subscales are added to provide a total score with a maximum of 28.
Change in Patient Determined Disease Steps
时间窗: Change from baseline at weeks 4, 8, and 12
A questionnaire with a self-assessment scale of disease status. The scores range from 0 = normal to 8 = bedridden.
Change in MS Walking Scale-12
时间窗: Change from baseline at weeks 4, 8, and 12.
A 12-item, patient-rated measure of how much MS compromises walking ability. Each item is rated from 1 = Not at all to 5 = extremely. The maximum total score = 60.
Change in Walking Endurance
时间窗: Change from baseline at weeks 4, 8, and 12
Distance walked in 6 min when walking at a brisk pace
Change in Modified Fatigue Impact Scale
时间窗: Change from baseline at weeks 4, 8, and 12.
A questionnaire that assesses the impact of fatigue experienced by persons with MS. Each of the 21 items is rated from 0 = Never to 5 = Almost always. The maximum total score = 105
次要结局
- Change in Romberg Quotient(Change from baseline at weeks 4, 8, and 12.)
- Change in Proprioception Tract(Change from baseline at weeks 4, 8, and 12.)
- Change in Discharge characteristics(Change from baseline at weeks 4, 8, and 12.)
- Change in Muscle Synergy Number(Change from baseline at weeks 4, 8, and 12)
- Change in Force Steadiness(Change from baseline at weeks 4, 8, and 12.)
- Change Conditioned H-reflex Amplitude(Change from baseline at weeks 4, 8, and 12.)
- Change in Muscle Synergy TIming(Change from baseline at weeks 4, 8, and 12.)
研究者
Roger Enoka
Professor
University of Colorado, Boulder