Back to resultsEffect of Intensive Language Therapy in Subacute Stroke Patients
Primary Purpose
Stroke, Rehabilitation, Language
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
language rehabilitation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive group
Conventional group
Arm Description
language rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks
language rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks
Outcomes
Primary Outcome Measures
Korean version-Western Aphasia Battery (AQ)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03168373
Brief Title
Effect of Intensive Language Therapy in Subacute Stroke Patients
Official Title
Effect of Intensive Language Therapy in Subacute Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation, Language
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive group
Arm Type
Experimental
Arm Description
language rehabilitation therapy by language therapist for 1 hours on every working day for 4 weeks
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
language rehabilitation therapy by language therapist for 30 minutes on every working day for 4 weeks
Intervention Type
Procedure
Intervention Name(s)
language rehabilitation therapy
Intervention Description
language therapy is language rehabilitation by language therapist during subacute phase in stroke patients
Primary Outcome Measure Information:
Title
Korean version-Western Aphasia Battery (AQ)
Time Frame
Change of Korean version- Western Aphasia Battery after language rehabilitation for 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25886039
Citation
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.
Results Reference
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Effect of Intensive Language Therapy in Subacute Stroke Patients
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