Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient

NCT03168360 | Completed

• 1 other identifier: 2016-04-156
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 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 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.

Conditions

Stroke; Rehabilitation; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Korean-Montreal Cognitive Assessment (K-MoCA)

  Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks

Study Arms (2)

Intensive group

EXPERIMENTAL

cognitive rehabilitation therapy for 1 hour by cognitive therapist on every working day for 4 weeks

Procedure: Cognitive rehabilitation

Conventional group

ACTIVE COMPARATOR

cognitive rehabilitation therapy for 30 minutes by cognitive therapist on every working day for 4 weeks

Procedure: Cognitive rehabilitation

Interventions

Cognitive rehabilitation PROCEDURE

Intensive cognitive rehabilitation by cognitive therapist for 1 hours on every working day during subacute stroke phase

Conventional group; Intensive group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Transient ischemic stroke

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (3)

• 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: 25886039 BACKGROUND

• 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.

  PMID: 34695300 DERIVED

• 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.

  PMID: 34196963 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yun-Hee Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

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

Locations

KR (1)