Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060150) titled 'Item and network analysis for functional independence measure in patients after acute stroke' on Dec. 22.
Study Type:
Observational
Primary Sponsor:
Institute - Kitasato University
Condition:
Condition - Stroke, ischemic stroke and intracerebral hemorrhage
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 1000
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068796
Disclaimer: Curated by HT Syndication.