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

NCT04720820 | Completed

• 1 other identifier: B-2012-654-308
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Early Supported Discharge; Acute stroke

Outcome Measures

Primary Outcomes (1)

• changes in Korean modified Barthel Index (K-MBI)

  K-MBI is an ordinal scale used to measure performance in activities of daily living(ADL). score ranges from 0 to 100, higher score meaning better ADL function.

  Baseline, 1 month after discharge, 3 months after onset, changes from baseline

Secondary Outcomes (13)

• modified Rankin Scale (mRS)

  Baseline, 1 month after discharge, 3 months after onset

• Korean Instrumental Activities of Daily Living (K-IADL)

  1 month after discharge, 3 months after onset

• Korean Reintegration to Normal Life Index (K-RNLI)

  1 month after discharge, 3 months after onset

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 1 month after discharge, 3 months after onset

• Korean Stroke Impact Scale ver 3.0 (K-SIS)

  1 month after discharge, 3 months after onset

Study Arms (2)

Early Supported Discharge (ESD) Group

EXPERIMENTAL

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.

Other: Early Supported discharge with home based Rehabilitation

Conventional Rehabilitation (CR) Group

ACTIVE COMPARATOR

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.

Other: Conventional rehabilitation

Interventions

Early Supported discharge with home based Rehabilitation OTHER

Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.

Early Supported Discharge (ESD) Group

Conventional rehabilitation OTHER

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

Conventional Rehabilitation (CR) Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Chungnam National University Hospital: collaborator
• Pusan National University Yangsan Hospital: collaborator

Study Sites (1)

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (2)

• 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 Nov;68(8):102025. doi: 10.1016/j.rehab.2025.102025. Epub 2025 Sep 18.

  PMID: 40972310 DERIVED

• 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.

  PMID: 34566853 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors are blinded to the patients' group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The trial consists of two arms; An Early Supported Discharge group and Conventional Rehabilitation group

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: March 1, 2021
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: June 19, 2025

Record last verified: 2023-11

Locations

KR (1)