UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062670 |
|---|---|
| Receipt number | R000071628 |
| Scientific Title | A prospective observational study of rehabilitation and functional outcomes in patients with disorders of consciousness |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/24 16:52:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective observational study of rehabilitation and functional outcomes in patients with disorders of consciousness
Acronym
A prospective observational study of rehabilitation and functional outcomes in patients with disorders of consciousness
Scientific Title
A prospective observational study of rehabilitation and functional outcomes in patients with disorders of consciousness
Scientific Title:Acronym
A prospective observational study of rehabilitation and functional outcomes in patients with disorders of consciousness
Region
| Japan |
Condition
Condition
Patients with brain injuries such as stroke, head trauma, hypoxic encephalopathy and encephalitis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
To investigate the associations of the severity and longitudinal changes of disorders of consciousness with functional outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Independence Measure score at discharge
Key secondary outcomes
The following outcome measures will be collected: total Functional Independence Measure (FIM) score and individual FIM subscale scores at admission; individual FIM subscale scores at discharge; total Coma Recovery Scale-Revised (CRS-R) score and individual CRS-R subscale scores at admission and discharge; FIM gain; FIM efficiency; length of hospital stay; discharge destination; and amount of rehabilitation provided.
Basic demographic and clinical information will also be collected, including age, sex, diagnosis, date of injury or disease onset, dates of admission and discharge, and treatment history. In addition, routinely collected assessment data on functional impairments and activity limitations obtained by the Department of Rehabilitation and the Rehabilitation Division will be included. Results of blood tests, imaging studies, and other examinations performed as part of routine clinical care will also be collected as necessary to determine disease severity, complications, general medical status, and clinical course.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
yosh1201@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Wada |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
yosh1201@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study.
Management information
Registered date
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071628
