Effect of Intensive Language Therapy in Subacute Stroke Patients

March 6, 2024 updated by: Yun-Hee Kim, Samsung Medical Center
Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of language rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive language rehabilitation during subacute phase to improve language function in patients with first-ever strokes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intensive language rehabilitation group - language rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks

Conventional language rehabilitation group

- language rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute first-ever stroke
  • Left hemispheric stroke
  • Korean version of Frenchay Aphasia Screening Test(K-FAST) < 25 (less than 65 years old), K-FAST <20 (65 years old and more than 65 years old) at 7 days after stroke onset
  • Right handedness

Exclusion Criteria:

  • Transient ischemic stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive group
language rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks
Procedure: language rehabilitation therapy
language therapy is language rehabilitation by language therapist during subacute phase in stroke patients
Active Comparator: Conventional group
language rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks
Procedure: language rehabilitation therapy
language therapy is language rehabilitation by language therapist during subacute phase in stroke patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Korean version-Western Aphasia Battery (AQ)
Time Frame: Change of Korean version- Western Aphasia Battery after language rehabilitation for 4 weeks
Change of Korean version- Western Aphasia Battery after language rehabilitation for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Yun-Hee Kim, MD,PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-07-147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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