Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea
NCT ID: NCT04720820
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2021-03-01
2023-11-29
Brief Summary
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The study is a double-armed prospective multi-centered, assessor-blinded randomized controlled trial comparing the effect of ESD program with conventional rehabilitation program.
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Detailed Description
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ESD service has been proven to be non-inferior in the functional and quality of life measures as well as cost-effective, compared to the conventional rehabilitation service in many countries, however the effectiveness of ESD service may differ among countries and medical, economical circumstances. This study aims to examine the effect of ESD service on the acute stroke patients with mild to moderate disabilities in Korea and demonstrate its feasibility as an alternative medical service option to those patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early Supported Discharge (ESD) Group
Patients in the ESD group will be discharged to home as soon as the acute medical treatment is finished. The patients will follow a pre-planned ESD program which consists of home-based rehabilitation (at least 30 minutes of physical therapy and 30 minutes of occupational therapy per week) offered by therapists. The ESD team will also provide social/medical services as needed. The ESD program will be provided till 1 months after discharge point.
Early Supported discharge with home based Rehabilitation
Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
Conventional Rehabilitation (CR) Group
The patients in CR group will be provided with inpatient rehabilitation after the acute medical treatment is finished. The length of inpatient rehabilitation may depend on the hospital's current program. Patients will be provided with outpatient based rehabilitation program if needed after discharge.
Conventional rehabilitation
Treatment will be provided according to current hospital's stroke rehabilitation program.
Interventions
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Early Supported discharge with home based Rehabilitation
Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
Conventional rehabilitation
Treatment will be provided according to current hospital's stroke rehabilitation program.
Eligibility Criteria
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Inclusion Criteria
* Patient who had acute stroke and admitted to hospital (excludes TIA)
* Patient who will be discharged to home within 30 days after onset
* Patient who has indwelling caregiver and is able to support in ESD program
* Patient who's initial mRS is 1-3
* Patient who's initial FAC is 3 or above
* Patient who's initial K-NIHSS consciousness scores (1a,1b,1c) are all 0
Exclusion Criteria
* Patient who is medically unstable requiring intense treatment
* Patient who has indwelling urinary catheter
* Patient who is unable to intake food by mouth
* Patient who is initial MMSE is below 15
* Patient who has uncontrolled pain
* Patient who has psychobehavioral problems
20 Years
ALL
No
Sponsors
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Chungnam National University Hospital
OTHER
Pusan National University Yangsan Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Nam-Jong Paik
Professor
Locations
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Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, South Korea
Countries
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References
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Chang WK, Jung YS, Choi JS, Kim WS, Sohn MK, Jee S, Shin YI, Ko SH, Ock M, Kim HJ, Paik NJ. Pragmatic multicenter randomized controlled study on early supported discharge after stroke in Korea: the KOMPACT study. Ann Phys Rehabil Med. 2025 Sep 18;68(8):102025. doi: 10.1016/j.rehab.2025.102025. Online ahead of print.
Chang WK, Kim WS, Sohn MK, Jee S, Shin YI, Ko SH, Ock M, Kim HJ, Paik NJ. Korean Model for Post-acute Comprehensive rehabilitation (KOMPACT): The Study Protocol for a Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge. Front Neurol. 2021 Sep 8;12:710640. doi: 10.3389/fneur.2021.710640. eCollection 2021.
Other Identifiers
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B-2012-654-308
Identifier Type: -
Identifier Source: org_study_id
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