NCT06666816招募中不适用
Observational Study for the Identification of Fatigue and Gait Biomarkers in Populations With Neuromuscular Pathologies in the Clinical Context and Daily Life
IRCCS Eugenio Medea2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年10月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Variation in walking speed during a 6-minutes walking test
研究概览
简要总结
This study has the general objective of observing walking parameters during a clinical test to objectively estimate fatigue in patients with neuromuscular diseases. Furthermore, the investigators want to evaluate the feasibility of collecting physical activity in daily life conditions during a one-week monitoring period using a wearable sensor.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ambulant adult patients with genetic diagnosis of muscular dystrophy/myopathy (dystrophinopathies, muscular dystrophies and congenital and non-congenital myopathies), of spinal muscular atrophy (SMA) and with molecular diagnosis of Charcot-Marie Tooth 1 or
- •independent walking, even with assistance;
排除标准
- •Dilated or ischemic heart disease with moderate impairment;
- •Chronic respiratory failure: forced vital capacity (FVC) < 40%; more than 5% of nocturnal time spent with peripheral oxygen saturation levels < 90.
结局指标
主要结局
Variation in walking speed during a 6-minutes walking test
时间窗: Baseline
Variation in walking speed calculated as difference between the first and the final minute of the a 6-minutes walking test
Subjective fatigue
时间窗: Baseline
Evaluation of subjective fatigue using the Fatigue Severity Scale (FSS). The minimum value is 0, the maximum is 63. Higher scores mean worse outcome.
次要结局
- Clinical progression of the neuromuscular disease(Baseline)
- Variation in gait variability during the 6-Minutes Walking Test(Baseline)
研究者
研究点 (2)
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