臨床研究等提出・公開システム

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

tele-rehabilitation

Kawabori Masahito

Hokkaido University Hospital

Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido

masahitokawabori@yahoo.co.jp

Miura Arisa

Hokkaido University Hospital

Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido

+81-11-706-7735

R-HX_jimu@pop.med.hokudai.ac.jp

Not Recruiting

Oct. 17, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

health services research

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.

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.

Both

cerebral hemorrhage

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.

Chronic, hemorrhage, brain

tele-rehabilitation, hemorrhage, brain, application

D002543

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

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

+81-11-706-7636

Oct. 15, 2024

No

none