Back to resultsEffect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient
Primary Purpose
Stroke, Rehabilitation, Cognitive Function
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cognitive rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Acute first-ever stroke
- Korean Mini-Mental State Examination: 11~24 at 7 days after stroke onset
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
cognitive rehabilitation therapy for 1 hour by cognitive therapist on every working day for 4 weeks
cognitive rehabilitation therapy for 30 minutes by cognitive therapist on every working day for 4 weeks
Outcomes
Primary Outcome Measures
Korean-Montreal Cognitive Assessment (K-MoCA)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03168360
Brief Title
Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient
Official Title
Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient
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 cognitive rehabilitation in stroke patients. In this study, the investigators assess the effects of the intensive cognitive rehabilitation during subacute phase to improve cognitive function at 6 months after onset in patients with first-ever strokes.
Detailed Description
Intensive cognitive rehabilitation group
cognitive therapy for 1 hours on every working day for 4 weeks
Conventional cognitive rehabilitation group
cognitive therapy 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, Cognitive Function
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
cognitive rehabilitation therapy for 1 hour by cognitive therapist on every working day for 4 weeks
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
cognitive rehabilitation therapy for 30 minutes by cognitive therapist on every working day for 4 weeks
Intervention Type
Procedure
Intervention Name(s)
Cognitive rehabilitation
Intervention Description
Intensive cognitive rehabilitation by cognitive therapist for 1 hours on every working day during subacute stroke phase
Primary Outcome Measure Information:
Title
Korean-Montreal Cognitive Assessment (K-MoCA)
Time Frame
Change of K-MoCa after intensive cognitive 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
Korean Mini-Mental State Examination: 11~24 at 7 days after stroke onset
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
background
PubMed Identifier
34695300
Citation
Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
Results Reference
derived
PubMed Identifier
34196963
Citation
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Results Reference
derived
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Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient
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