UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062280 |
|---|---|
| Receipt number | R000070794 |
| Scientific Title | Relationship between each subsection of the Mini-Balance Evaluation Systems Test and the Functional Independence Measure for walking, toilet transfer, and toileting in patients with subacute stroke: an exploratory cross-sectional study |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/20 15:43:45 |
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Basic information
Public title
Relationship between balance ability and activities of daily living (walking, toileting, etc.) in patients with subacute stroke
Acronym
Balance and ADL in stroke
Scientific Title
Relationship between each subsection of the Mini-Balance Evaluation Systems Test and the Functional Independence Measure for walking, toilet transfer, and toileting in patients with subacute stroke: an exploratory cross-sectional study
Scientific Title:Acronym
Relationship between Mini-BESTest subsections and FIM in subacute stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a pilot study for future multicenter research, this study aims to exploratorily investigate the relationship between the subsections of the Mini-BESTest (anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait) and FIM walking, toilet transfer, and toilet use in patients with subacute stroke, in order to obtain hypothesis-generating findings.
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor item scores of the Functional Independence Measure (FIM) for walking, toilet transfer, and toilet use.
[Timepoint] In principle, within 1 week from the day standing with supervision becomes possible.
Key secondary outcomes
Scores of the Mini-BESTest subsections (anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait), and the time taken for the Timed Up and Go (TUG) test (only for those who can perform it).
[Timepoint] In principle, within 1 week from the day standing with supervision becomes possible.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age 18-90 years.
2) First-ever stroke.
3) Diagnosed with stroke.
4) Admitted to convalescent rehabilitation ward.
5) Able to maintain standing with supervision within 90 days of onset.
6) Provided informed consent.
Key exclusion criteria
1) Patients with subarachnoid hemorrhage.
2) Severe cognitive impairment (FIM cognitive total score < 18).
3) Patients with severe complications.
4) Patients who did not provide informed consent.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Kaminaga |
Organization
Heisei Yokohama Hospital
Division name
Department of Rehabilitation
Zip code
244-0003
Address
550 Totsuka-cho, Totsuka-ku, Yokohama, Kanagawa
TEL
045-860-1777
kaminaga.kosei@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Nakanishi |
Organization
Heisei Yokohama Hospital
Division name
Department of Rehabilitation
Zip code
244-0003
Address
550 Totsuka-cho, Totsuka-ku, Yokohama, Kanagawa
TEL
045-860-1777
Homepage URL
nakanishi.hideto@hmw.gr.jp
Sponsor or person
Institute
Heisei Yokohama Hospital
Institute
Department
Personal name
Kosei Kaminaga
Funding Source
Organization
None
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, Heisei Yokohama Hospital
Address
550 Totsuka-cho, Totsuka-ku, Yokohama, Kanagawa
Tel
045-860-1777
info@yokohamahp.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
平成横浜病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 09 | Month | 30 | Day |
Other
Other related information
This is a single-center, exploratory observational study targeting stroke patients admitted to a convalescent rehabilitation ward. Data from assessments (Mini-BESTest, FIM, TUG, etc.) conducted within the scope of standard care and rehabilitation will be collected to cross-sectionally investigate the relationship between balance components and independence in activities of daily living.
Management information
Registered date
| 2026 | Year | 07 | Month | 20 | Day |
Last modified on
| 2026 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070794
