Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea

NCT ID: NCT04720820

Last Updated: 2025-06-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-11-29

Brief Summary

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The study aims to examine the effect of early supported discharge (ESD) service on the functional outcomes and quality of life of acute stroke patients with mild to moderate disability in Korea.

The study is a double-armed prospective multi-centered, assessor-blinded randomized controlled trial comparing the effect of ESD program with conventional rehabilitation program.

Detailed Description

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Early Supported Discharge (ESD) is a form of medical service applicable to acute stroke patients with mild to moderate disabilities. ESD service was developed to facilitate patient to their daily livings at home, reduce the length of stay in the hospital with possibly better or equivalent outcomes for patients and caregivers.

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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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial consists of two arms; An Early Supported Discharge group and Conventional Rehabilitation group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The assessors are blinded to the patients' group

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.

Group Type EXPERIMENTAL

Early Supported discharge with home based Rehabilitation

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type OTHER

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.

Intervention Type OTHER

Conventional rehabilitation

Treatment will be provided according to current hospital's stroke rehabilitation program.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient who is over 20 years old
* 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 had Transient Ischemic Attack
* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chungnam National University Hospital

OTHER

Sponsor Role collaborator

Pusan National University Yangsan Hospital

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nam-Jong Paik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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South Korea

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.

Reference Type DERIVED
PMID: 40972310 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34566853 (View on PubMed)

Other Identifiers

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B-2012-654-308

Identifier Type: -

Identifier Source: org_study_id

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