Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month (4 weeks).
研究概览
简要总结
The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.
详细描述
Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month. Each value will be compare to evaluate whether the groups of patient improve.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute stroke < 24 hours.
- •Patients with impairment up to 4 on NIHSS scale.
- •Family support.
- •Informed consent.
排除标准
- •Presence of another disease not well controlled.
- •Patient with dementia.
研究组 & 干预措施
Placebo
In this group we will use Placebo cream, in the early rehabilitations in the upper extremity
干预措施: Placebo (Drug)
Folrex
In this group we will use Folrex cream, in the early rehabilitations in the upper extremity
干预措施: Folrex (Drug)
结局指标
主要结局
Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month (4 weeks).
时间窗: 4 weeks
次要结局
- Barthel index(4 weeks)
- National Institutes of Health Stroke Scale (NIHSS)(4 weeks)