jRCT1010240041招募中不适用
An exploratory study to investigate the feasibility, efficacy, and safety of tele-rehabilitation for intracerebral transplantation of autologous bone marrow stromal cells combined with recombinant peptide scaffold for patients with chronic intracerebral hemorrhage
Masahito Kawabori0 个研究点目标入组 8 人开始时间: 2024年11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
- 8
- 主要终点
- Safety of rehabilitation
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Health Services Research
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 70age old not（—）
- 性别
- All
入选标准
- •Patients who have completed the 6-month evaluation of the RAINBOW-Hx study.
- •Patients who can understand how to use the tele-rehabilitation system.
- •Patients who have received a sufficient explanation of their participation in this study and can provide written consent of their own free will after fully understanding the study. If the patient is unable to sign the document themselves, a proxy may sign it. However, written consent by a proxy will not be accepted if the patient is not fully capable of understanding or expressing their will.
排除标准
- •Patients who experienced a serious adverse event (SAE) in the RAINBOW-Hx study or who have continued to experience moderate or severe adverse events since the RAINBOW-Hx study, and who are judged by the principal investigator to be at high risk for safety.
- •Patients who are otherwise judged by the principal investigator or co-investigators to be inappropriate as subjects.
结局指标
主要结局
Safety of rehabilitation
时间窗: up to 6 months after the start of the program
Safety of rehabilitation using a tele-rehabilitation system
次要结局
- feasibility of rehabilitation
- change from baseline of RAINBOW-Hx study
- change from baseline of this study
研究者
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