Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03168360
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 85.9
• Patients Per Site Per Month: 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 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Rehabilitation; Cognitive Function	Procedure: Cognitive rehabilitation	N/A

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

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 Cognitive Rehabilitation in Subacute Stroke Patient
• 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 cognitive rehabilitation therapy for 1 hour by cognitive therapist on every working day for 4 weeks	Procedure: Cognitive rehabilitation; Intensive cognitive rehabilitation by cognitive therapist for 1 hours on every working day during subacute stroke phase
Active Comparator: Conventional group cognitive rehabilitation therapy for 30 minutes by cognitive therapist on every working day for 4 weeks	Procedure: Cognitive rehabilitation; Intensive cognitive rehabilitation by cognitive therapist for 1 hours on every working day during subacute stroke phase

Outcome Measures

Primary Outcome Measures

1. Korean-Montreal Cognitive Assessment (K-MoCA) [Change of K-MoCa after intensive cognitive 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

• Korean Mini-Mental State Examination: 11~24 at 7 days after stroke onset

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

• 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.

• Responsible Party: Yun-Hee Kim, MD, PhD, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03168360
• Other Study ID Numbers: 2016-04-156
• 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: Stroke

Study Results

No Results Posted as of May 9, 2022