UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060150 |
|---|---|
| Receipt number | R000068796 |
| Scientific Title | Item and network analysis for functional independence measure in patients after acute stroke |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/21 13:11:27 |
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Basic information
Public title
Item and network analysis for functional independence measure in patients after acute stroke
Acronym
Item and network analysis for functional independence measure in patients after acute stroke
Scientific Title
Item and network analysis for functional independence measure in patients after acute stroke
Scientific Title:Acronym
FIM-CogNet
Region
| Japan |
Condition
Condition
Stroke, ischemic stroke and intracerebral hemorrhage
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to characterise discharge Functional Independence Measure(FIM) cognition in patients with acute stroke by, 1)describing item attainability(difficulty) and discrimination using binary item analysis based on a clinically interpretable threshold(FIM>=5, modified independence or better), and 2)estimating the conditional dependency structure among the five cognitive items using ordinal network analysis that preserves the original 7-point ratings.
Basic objectives2
Others
Basic objectives -Others
To examine item characteristics(difficulty and discrimination) and interrelationships among the five discharge FIM cognitive items in patients with acute stroke.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Edge weights (regularised partial correlations) and node strength centrality in a partial correlation network estimated from the 7-point ordinal discharge FIM cognitive item ratings (comprehension, expression, social interaction, problem solving, and memory).
Key secondary outcomes
Attainment rates using a clinically interpretable threshold (FIM>=5) and corrected item-total correlations based on dichotomised item scores for item analysis. As a sensitivity analysis, we compare the primary ordinal-based network with a network estimated using Pearson correlations treating item scores as approximately continuous.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the Stroke Care Unit at Kitasato University Hospital.
Primary diagnosis of ischemic stroke or intracerebral hemorrhage.
Received in-hospital rehabilitation services, including occupational, physical, and/or speech therapy.
Discharge FIM cognition was assessed, with complete data available for all five cognitive items, comprehension, expression, social interaction, problem solving, and memory.
Study period, April 2019 to November 2023.
Key exclusion criteria
Missing data for any of the five discharge FIM cognitive items.
Missing key demographic or clinical variables, such as age, sex, or stroke subtype.
In-hospital death.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Amano |
Organization
Kitasato University
Division name
Department of Rehabilitation
Zip code
252-0329
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa
TEL
(042)-778-9849
s-amano@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Amano |
Organization
Kitasato University
Division name
Department of Rehabilitation
Zip code
252-0329
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa
TEL
0427789849
Homepage URL
s-amano@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0373, JAPAN
Tel
+81-42-778-9849
s-amano@kitasato-u.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
| 2025 | Year | 12 | Month | 22 | 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
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 06 | Day |
Date analysis concluded
| 2026 | Year | 01 | Month | 07 | Day |
Other
Other related information
Two analyses are performed using the five discharge FIM cognitive items. 1)For item analysis, each item is dichotomised using a clinically interpretable threshold(FIM>=5, modified independence or better), and item properties are summarised using CTT indices, including attainment rates(difficulty) and corrected item-total correlations(discrimination). 2)For network analysis, the original 7-point ordinal ratings are retained and treated as ordered factors. A network is estimated based on a polychoric correlation matrix to characterise conditional dependencies among items. Uncertainty is evaluated using bootstrap procedures, including 95% confidence intervals for edge weights and centrality stability. A sensitivity analysis is conducted using Pearson correlations treating item scores as approximately continuous.
Management information
Registered date
| 2025 | Year | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068796
