Does Rhythmic Auditory Stimulation Influence Walking Speed in the 6-minute Walk Test in Patients With Myasthenia Gravis?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 6-minute walk test (6MWT)
研究概览
简要总结
The aim of this study is to investigate if rhythmic auditory stimulation can influence walking speed, during a 6MWT in patients with myasthenia gravis (MG).
详细描述
Background
- The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed.
- Rhythmic auditory stimulation has repeatedly been shown to improve gait parameters in individuals with neurologic impairment.
The aim of this study is to investigate if rhythmic auditory stimulation can influence walking speed, during a 6MWT in patients with myasthenia gravis.
Patients with MG are asked to complete two 6MWTs separated by minimum 30 minutes of rest. Before the 6MWTs patient is instructed to walk 60 m as fast as possible, and their steps per minute (SPM) is recorded. When completing the 6MWTs, one of the tests is accompanied by music (m6MWT) with a beat per minute (BPM) corresponding to patients' SPM. The order of the 6MWTs is randomly decided by pre-ordered sealed envelopes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide signed informed consent.
- •Able to read and understand Danish or English.
- •Diagnosis of mild to moderate MG (Able to provide signed informed consent.
- •Able to read and understand Danish or English.
- •Diagnosed with generalized mild to moderate myasthenia gravis (I-IV on the Myasthenia Gravis Foundation of American Clinical Classification, MGFA).
- •Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive, or abnormal repetitive nerve stimulation testing (decrement > 10%) on electromyography (EMG) or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acetylcholinesterase inhibitors.
- •Ability to walk > 60 meters in a 6MWT.
排除标准
- •MGFA grade V disease
- •Other disorders that are not related to MG, or drugs, that interfere with muscle strength, walking ability, balance and fatigue (e.g. heart failure).
- •Serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer).
- •Dementia or pregnancy.
- •Unspecified reasons judged by the investigator
结局指标
主要结局
6-minute walk test (6MWT)
时间窗: 6 minutes
The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.
次要结局
- Myasthenia gravis composite score (MGC)(30 minutes)
- The Borg Rating of Perceived Exertion (RPE) scale.(2 minutes)
- Heart rate(5 minutes)
研究者
Linda Kahr Andersen
Research Physiotherapist, PhD student
Rigshospitalet, Denmark