Transcutaneous Electrical Nerve Stimulation in Persons With MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 6-minute walk test
研究概览
简要总结
Persons with multiple sclerosis (pwMS) often have an increased sense of fatigue. Furthermore, they present walking difficulties which negatively affects their mobility and results in an additional increase of fatigue. Previous literature suggests that transcutaneous electrical nerve stimulation (TENS) of leg muscles might increase their walking capacity and decrease perception of fatigue. In the present study we aim to investigate whether TENS of leg muscles reduces walking difficulties and sense of fatigue in pwMS in comparison with a short strength training protocol or no training. A similar aim is addressed after TENS of elbow flexor muscles.
Subjects with relapsing remitting or progressive MS, will undergo transcutaneous electrical nerve stimulation (TENS), strength exercises (SExerc), both TENS and SExerc (COMB) simultaneously, or sham stimulation without training (CON) of both leg and arm muscles. Force and fatigue measurements are performed before, directly after and three weeks after the training sessions and contain walking, fatigue, and strength assessments.
Main study parameters are changes in the scores of i) the six-minute walking test (6-MWT), ii) the perceived walking disability (MSWS-12) and iii) fatigue questionnaires (FSS and MFIS). Additional study parameters are changes in muscle force and muscle fatigability.
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
- •EDSS score < 7
- •MSWS score > 30
- •FSS score > 4 or MFIS score >
- •no known cardiovascular disorder or having a positive advice on a sport medical examination
排除标准
- •being a participant in an exercise study
- •having a psychiatric disorder
- •having cognitive or communication problems which reduces the capacity to understand instructions
- •planned a change in medication during the training period
- •having a neurological disorder other than MS
- •having cardiovascular disorders and no positive advice from a sport medical examination
- •having a pacemaker or another implantable electronic apparatus.
- •being pregnant
结局指标
主要结局
6-minute walk test
时间窗: 6 weeks
This test assesses submaximal aerobic capactity. Subjects walk for 6 minutes starting at mark on the floor at the beginning of a 30-m long hallway and walk to the next mark at the end of the hallway as quickly as possible, but safely. The distance which is walked by the subject is measured. Subjects may use assistive devices when performing the task.
chair-stand test
时间窗: 6 weeks
This test assesses functional lower extremity strength. Subjects sit on a chair and stand up repeatedly for 30 s. Arms of the subject are crossed and held against the chest. The number of cycles of standing up from sitting are counted.
Fatigue Severity Scale (FSS)
时间窗: 6 weeks
This is a questionnaire related to the impact of fatigue on daily life. The questionnaire consists of 9 questions with a 7-point scale ranging from 'completely agree' to 'completely disagree'. The total score ranges from 9 to 63; higher scores reflect a higher impact.
Modified Fatigue Impact Scale (MFIS)
时间窗: 6 weeks
This is a questionnaire related to sense of fatigue. The questionnaire consist of 21 questions providing assessment of the effect of fatigue in terms of physical, cognitive and psychosocial function. The total score ranges from 0 to 84; higher scores reflect a higher impact of fatigue.
12-item MS walking scale (MSWS-12)
时间窗: 6 weeks
This is a patient-base measure of walking ability. The questionnaire consists of 12 items with a 5-point scale ranging from 'not at all' to 'extremely'. The total score ranges from 5 to 60, with higher scores reflecting more walking difficulties.
次要结局
- Elbow flexor muscle force (maximal and submaximal levels)(6 weeks)
- Effort during submaximal contractions with elbow flexors(6 weeks)
- Knee extensor muscle force (maximal and submaximal levels)(6 weeks)
- Handgrip force(6 weeks)
- Effort during submaximal contractions with knee extensors(6 weeks)