Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062670) titled 'A prospective observational study of rehabilitation and functional outcomes in patients with disorders of consciousness' on Sept. 1.

Study Type: Observational

Primary Sponsor: Institute - Fujita Health University

Condition: Condition - Patients with brain injuries such as stroke, head trauma, hypoxic encephalopathy and encephalitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate the association between the severity of impaired consciousness at admission, changes in consciousness over time, and functional outcomes in patients with brain injury who presented with impaired consciousness and underwent inpatient rehabilitation at the Rehabilitation Ward of Fujita Health University Hospital. In addition, we will examine the associations between functional outcomes and other clinical factors and assess their relative contributions to these outcomes. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients admitted to the Rehabilitation Ward of Fujita Health University Hospital. 2. Patients aged 18 years or older with brain injury, including stroke, traumatic brain injury, hypoxic encephalopathy, or encephalitis, who were admitted to the Rehabilitation Ward of Fujita Health University Hospital within 3 months of injury or disease onset. 3. Patients assessed by the attending physician as having impaired consciousness. 4. Patients who provided written informed consent to participate in the study after receiving a full explanation of the study and demonstrating adequate understanding, either personally or through a legal representative. 5. Patients able to undergo routine clinical assessments in Japanese. Key exclusion criteria - 1. Patients who themselves, or whose legal representatives, have requested withdrawal of consent to participate in the study. 2. Patients whose impaired consciousness is considered to be primarily attributable to systemic conditions, including metabolic, endocrine, respiratory, infectious, or other systemic causes. 3. Patients with a pre-existing central nervous system disorder, such as stroke, traumatic brain injury, hypoxic encephalopathy, or encephalitis, that occurred before the onset of the brain injury responsible for the current hospitalization, and whose level of consciousness is considered difficult to assess because of the effects of the pre-existing condition, as determined by the attending physician or principal investigator. 4. Patients deemed unsuitable for participation in this study by the attending physician or principal investigator. Target Size - 200

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 07 Month 01 Day Date of IRB - 2026 Year 08 Month 07 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071628

Disclaimer: Curated by HT Syndication.