NCT03168386

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 motor rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive motor rehabilitation during subacute phase to improve motor function at 6 months after onset in patients with first-ever strokes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

7.2 years

First QC Date

May 22, 2017

Last Update Submit

March 6, 2024

Conditions

StrokeRehabilitationMotor Function

Outcome Measures

Primary Outcomes (1)

  • Upper limb score of Fugl-Meyer assessment

    Change of upper limb score of Fugl-Meyer assessment after intensive motor rehabilitation for 4 weeks

Study Arms (1)

Intensive motor rehabilitation group

EXPERIMENTAL
Procedure: Intensive motor rehabilitation

Interventions

Intensive motor rehabilitationPROCEDURE

Intensive motor rehabilitation during subacute stroke phase

Intensive motor rehabilitation group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute first-ever stroke
  • Upper limb score of Fugl-Meyer assessment at 7 days after onset : 25\~84

You may not qualify if:

  • Transient ischemic stroke
  • Joint contracture of affected upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

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

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yun-Hee Kim, MD,PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Intenstive motor rehabilitation
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)