Effect of Intensive Language Therapy in Subacute Stroke Patients

Sponsor
Samsung Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03168373
Collaborator
(none)
150
1
2
85.9
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: language rehabilitation therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Intensive Language Therapy in Subacute Stroke Patients
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Korean version-Western Aphasia Battery (AQ) [Change of Korean version- Western Aphasia Battery after language rehabilitation for 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yun-Hee Kim, MD, PhD, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT03168373
Other Study ID Numbers:
  • 2016-07-147
First Posted:
May 30, 2017
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022