- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502326
Functional Changes and Home Discharge After Inpatient Stroke Rehabilitation
Association Between Changes in Integrated Rehabilitation Functional Assessment and Discharge Destination in Patients With Stroke in a Post-Acute Rehabilitation Hospital: A Retrospective EMR-Based Observational Study
This retrospective observational study will evaluate whether changes in functional status during inpatient rehabilitation are associated with discharge destination in patients with stroke treated at a post-acute rehabilitation hospital. The study will use de-identified electronic medical record data from adult patients with stroke who were admitted to Zenith Hospital and discharged between January 1, 2024 and March 31, 2025.
Integrated rehabilitation functional assessment data obtained at admission and discharge will be analyzed, including the Korean Modified Barthel Index (K-MBI), Functional Ambulation Category (FAC), Berg Balance Scale (BBS), Mini-Mental State Examination (MMSE), and Manual Function Test (MFT). The main objective is to determine whether changes in these measures during hospitalization are associated with discharge destination, defined as home discharge versus transfer to another institution.
Approximately 150 eligible patients are expected to be included. Only existing de-identified EMR data will be used. No direct participant contact, additional data collection, or protocol-assigned intervention will occur. Findings from this study may provide evidence to support discharge planning and community reintegration strategies for patients with stroke receiving post-acute rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is a major cause of disability, and discharge destination after inpatient rehabilitation is an important clinical and social outcome. In post-acute rehabilitation settings, integrated functional assessments are routinely performed during hospitalization, but there is limited evidence on whether the magnitude of functional improvement between admission and discharge is associated with home discharge among patients with stroke in Korean rehabilitation hospitals. This study is designed to address that gap using de-identified electronic medical record data from a post-acute rehabilitation hospital.
The primary purpose of this study is to investigate the association between changes in integrated rehabilitation functional assessment scores during hospitalization and discharge destination in patients with stroke. Specifically, the study will evaluate whether changes in Korean Modified Barthel Index (K-MBI), Functional Ambulation Category (FAC), Berg Balance Scale (BBS), Mini-Mental State Examination (MMSE), and Manual Function Test (MFT) are associated with home discharge versus transfer to another institution.
This is a retrospective observational study conducted at Zenith Hospital, a post-acute rehabilitation hospital in the Republic of Korea. The study population will include adult patients with stroke who were admitted to the rehabilitation ward and discharged between January 1, 2024 and March 31, 2025. Eligible participants must have integrated rehabilitation functional assessment data recorded in the electronic medical record at both admission and discharge. Patients with missing admission or discharge functional assessment data, terminal illness preventing rehabilitation, in-hospital death, or insufficient EMR data for analysis will be excluded.
The main independent variables are changes in functional assessment scores between admission and discharge, including delta K-MBI, delta FAC, delta BBS, delta MMSE, and delta MFT. The primary outcome is discharge destination, categorized as home discharge or transfer to another institution. Covariates available in the EMR, such as age, sex, length of stay, and stroke type, will also be analyzed as potential confounders.
The study procedures are as follows: the hospital medical records team will identify potentially eligible patients according to the inclusion and exclusion criteria; all direct identifiers will be removed from the EMR data; a study-specific de-identified code will be assigned; and only de-identified data will be provided to the investigator for analysis. The investigator will calculate functional changes and perform statistical analyses to identify factors associated with discharge destination. There will be no participant contact, no prospective enrollment, no survey administration, and no intervention assigned as part of this study.
The study has been reviewed and approved by the Public Institutional Bioethics Committee No. 1 designated by the Ministry of Health and Welfare (Approval No. P01-202512-01-054). The findings are expected to provide practical evidence for discharge planning, patient stratification, and community reintegration support in post-acute stroke rehabilitation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Seoul, South Korea
- Zenith Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 19 years or older
- Patients with stroke who were admitted to and discharged from the post-acute rehabilitation ward at Zenith Hospital between January 1, 2024 and March 31, 2025
- Patients with integrated rehabilitation functional assessment data recorded in the electronic medical record at both admission and discharge, including Korean Modified Barthel Index (K-MBI), Functional Ambulation Category (FAC), Berg Balance Scale (BBS), Mini-Mental State Examination (MMSE), and Manual Function Test (MFT)
Exclusion Criteria:
- Missing admission or discharge functional assessment data
- Patients with terminal illnesses that made rehabilitation treatment infeasible, such as advanced cancer or end-stage heart failure
- In-hospital death or transfer before discharge assessment, resulting in no discharge functional assessment data
- Insufficient electronic medical record data for the study analysis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Home Discharge
Patients with stroke who were discharged to home after inpatient rehabilitation.
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Usual inpatient rehabilitation received during admission as part of routine clinical care.
No intervention was assigned by the study protocol.
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Transfer to Another Institution
Patients with stroke who were transferred to another institution after inpatient rehabilitation.
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Usual inpatient rehabilitation received during admission as part of routine clinical care.
No intervention was assigned by the study protocol.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discharge Destination
Time Frame: At discharge from inpatient rehabilitation, up to 15 months after admission
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Discharge destination assessed at discharge from inpatient rehabilitation, categorized as home discharge or transfer to another institution.
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At discharge from inpatient rehabilitation, up to 15 months after admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Korean Modified Barthel Index (K-MBI) score
Time Frame: From admission to discharge from inpatient rehabilitation, up to 15 months
|
Change in Korean Modified Barthel Index score from admission to discharge.
The Korean Modified Barthel Index is a measure of activities of daily living with scores ranging from 0 to 100, where higher scores indicate greater independence.
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From admission to discharge from inpatient rehabilitation, up to 15 months
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Change in Functional Ambulation Category (FAC) score
Time Frame: From admission to discharge from inpatient rehabilitation, up to 15 months
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Change in Functional Ambulation Category score from admission to discharge.
The Functional Ambulation Category is a measure of walking ability with scores ranging from 0 to 5, where higher scores indicate better ambulation.
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From admission to discharge from inpatient rehabilitation, up to 15 months
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Change in Berg Balance Scale (BBS) score
Time Frame: From admission to discharge from inpatient rehabilitation, up to 15 months
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Change in Mini-Mental State Examination score from admission to discharge.
The Mini-Mental State Examination is a measure of cognitive function with scores ranging from 0 to 30, where higher scores indicate better cognitive function.
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From admission to discharge from inpatient rehabilitation, up to 15 months
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Change in Mini-Mental State Examination (MMSE) score
Time Frame: From admission to discharge from inpatient rehabilitation, up to 15 months
|
Change in Mini-Mental State Examination score from admission to discharge.
The MMSE is a measure of cognitive function with scores ranging from 0 to 30, where higher scores indicate better cognitive status.
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From admission to discharge from inpatient rehabilitation, up to 15 months
|
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Change in Manual Function Test (MFT) score
Time Frame: From admission to discharge from inpatient rehabilitation, up to 15 months
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Change in Manual Function Test score from admission to discharge.
The Manual Function Test is a measure of upper extremity motor function with scores ranging from 0 to 32, where higher scores indicate better upper extremity function.
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From admission to discharge from inpatient rehabilitation, up to 15 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P01-202512-01-054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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