Effect of Intensive Language Therapy in Subacute Stroke Patients
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 2016
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 7, 2024
March 1, 2024
7.2 years
May 22, 2017
March 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Korean version-Western Aphasia Battery (AQ)
Change of Korean version- Western Aphasia Battery after language rehabilitation for 4 weeks
Study Arms (2)
Intensive group
EXPERIMENTALlanguage rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks
Conventional group
ACTIVE COMPARATORlanguage rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks
Interventions
language therapy is language rehabilitation by language therapist during subacute phase in stroke patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Transient ischemic stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim YH. Korean Stroke Cohort for functioning and rehabilitation (KOSCO): study rationale and protocol of a multi-centre prospective cohort study. BMC Neurol. 2015 Mar 25;15:42. doi: 10.1186/s12883-015-0293-5.
PMID: 25886039BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yun-Hee Kim, MD,PhD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 22, 2017
First Posted
May 30, 2017
Study Start
November 1, 2016
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
March 7, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share