UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063492 |
|---|---|
| Receipt number | R000072452 |
| Scientific Title | Factors Associated with Motivation and Its Association with Functional Outcomes After Stroke: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/11/02 08:48:03 |
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Basic information
Public title
Factors Associated with Motivation and Its Association with Functional Outcomes After Stroke: A Prospective Observational Study
Acronym
Factors Associated with Motivation and Its Association with Functional Outcomes After Stroke: A Prospective Observational Study
Scientific Title
Factors Associated with Motivation and Its Association with Functional Outcomes After Stroke: A Prospective Observational Study
Scientific Title:Acronym
Factors Associated with Motivation and Its Association with Functional Outcomes After Stroke: A Prospective Observational Study
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate how motivation, fatigue, apathy and depression at the time of admission are associated with functional outcomes in stroke patients who underwent inpatient rehabilitation at the Rehabilitation Ward of Fujita Health University Hospital, a designated specialised hospital, whilst also examining their relationships with and influences on other factors.
Basic objectives2
Others
Basic objectives -Others
To investigate of the Relationship between Motivation, Fatigue, Apathy and Depression and Their Functional Consequences
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 FIM score and scores for each subscale at admission; total FIM score and scores for each subscale at discharge; MORE scale; HAM-D6; FSS; total motivation score and scores for each subscale; FIM gain; FIM efficiency; length of stay; discharge destination; and volume 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 the Fujita Health University Hospital (a designated specialised hospital)
2. Patients with a first-episode stroke
Note: Stroke includes cerebral infarction, cerebral haemorrhage and subarachnoid haemorrhage.
3. Patients admitted to the Rehabilitation Ward of Fujita Health University Hospital (a Designated Function Hospital) within three months of sustaining the injury or the onset of the disease
4. Patients aged 18 years or over who, prior to participating in this study, received a full explanation, demonstrated a thorough understanding of the study, and provided written informed consent of their own free will
5. Patients capable of undergoing routine clinical assessments in Japanese
Key exclusion criteria
1. Patients who have requested to withdraw their consent to participate in this study
2. Patients whom the attending physician has judged to be unsuitable for psychological and behavioural assessment due to severe impairment of consciousness, severe aphasia, severe cognitive impairment, psychiatric symptoms, etc.
3. Patients whom the attending physician or the principal investigator has judged to be unsuitable for inclusion in this study
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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 02 | 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 | 10 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 11 | 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 | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072452
