tele-rehabilitation

JRCT ID: jRCT1010240041

Registered date:17/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: cerebral hemorrhage
• Date of first enrollment: 17/10/2024
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Using a tele-rehabilitation system that connect the the investigator and the subject, the subject will carry out rehabilitation via screen once a week for about an hour for six months under the guidance of the investigator. In addition, a rehabilitation program will be provided that the subject can carry out independently.

Outcome(s)

• Primary Outcome: Safety of rehabilitation using a tele-rehabilitation system up to 6 months after the start of the program

Secondary Outcome

Evaluate the feasibility of rehabilitation using the tele-rehabilitation system
Evaluate the change from the baseline of the RAINBOW-Hx study for the efficacy endpoints
Evaluate the change from the baseline of this study for the efficacy endpoints

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

1. Patients who have completed the 6-month evaluation of the RAINBOW-Hx study.
2. Patients who can understand how to use the tele-rehabilitation system.
3. 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.

Exclude criteria

1. 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.
2. Patients who are otherwise judged by the principal investigator or co-investigators to be inappropriate as subjects.

Related Information

• Primary Sponsor: Kawabori Masahito
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development