Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Change from Baseline in ALSFRS R
研究概览
简要总结
ErmoSLA is a multicentric, randomized, controlled trial to compare effects of an "intensive" or "standard" motor rehabilitation treatment on motor disability in people with ALS
详细描述
The study is a multicentric, randomized, controlled trial to compare effects of standard versus intensive motor rehabilitation treatment for people with ALS.
Eligible patients are going to be randomly assigned to the Standard or Intensive treatment (controlling for ALSFRSR rates at enrollment, age and site of onset). Randomization ratio is 1:1.
Standard treatment: 2 sessions/week of motor rehabilitation treatment (45 minutes each one) for 10 weeks for a total of 20 sessions. The program consists of exercises for aerobic endurance, reinforcement at low load and stretching. At the end of the 20 sessions patient and caregiver are going to continue activity with supervision through regular follow up.
Intensive treatment is characterized by an increased volume of the above mentioned exercises: 5 sessions/week (45 minutes each one) for 10 weeks for a total of 50 sessions. At the end of the 50 sessions patient and caregiver are going to continue activity with supervision through regular follow up.
Collection and analysis of data
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of possible, probable or definite ALS according to the Revised El Escorial Criteria
- •Time from diagnosis <18 months at screening.
- •Forced vital capacity (FVC)> 50% at screening
- •Written informed consent
- •Patients will be required to take the full dose of Riluzole, but not assuming Riluzole do not constitute a criterion for exclusion.
排除标准
- •Enrolment in any other clinical trial in the three months prior to screening
- •Tracheostomy or NIV for> 23h/day for 14 consecutive days at screening.
- •Diagnosis of severe neurodegenerative diseases in addition to the ALS
- •Diagnosis of severe heart disease, current neoplasia, any unstable medical condition that contraindicates an intensive rehabilitation treatment
- •State of pregnancy or breastfeeding
- •Residency outside Emilia-Romagna Region
- •Lack of multidisciplinary follow-up
结局指标
主要结局
Change from Baseline in ALSFRS R
时间窗: 12 months
次要结局
- Quality of Life: measured by McGill and ALSAQ40 scales(12 months)
- Depression measured by Beck Inventory Scale(12 months)
- Perceived quality of care(12 months)
- Respiratory function: measured by FVC(12 months)
- Disease symptoms (fatigue) measured with FSS(12 months)
- Rate of complications related to the disease: pressure sores, hospitalizations, infections(12 months)
- Tracheostomy free survival(12 months)
- Time to supporting procedures (NIV and PEG)(12 months)
研究者
Jessica Mandrioli
MD, Department of Neuroscience, St. Agostino-Estense Hospital, Modena (IT)
Azienda Unita' Sanitaria Locale Di Modena