Recovery Prediction of Motor Function Using Neuroimaging... | NCT03365596

Studies
Recovery Prediction of Motor Function Using Neuroimaging Techniques in Subacute Stroke Patients

NCT03365596

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Mar 8, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Stroke

Interventions

Conventional therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Jan 26, 2023Actual

First Submitted Date

Nov 27, 2017

First Submission Date that Met QC Criteria

Dec 3, 2017

First Posted Date

Dec 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2023

Last Update Posted Date

Mar 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prediction of recovery from stroke can assist in the planning of impairment-focused rehabilitation. To achieve better prediction for clinical purposes, this study investigated a new prediction model with low inter-individual variability and high accuracy using neuroimaging techniques.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subacute stroke			Other: Conventional therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional therapy	Other	According to the status of a patient, optimized therapy will be applied.	Subacute stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl-Meyer Assessment score at 3 months after stroke onset	Measurement of motor function of upper and lower extremities	3 months after stroke onset

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First-ever stroke patients
Unilateral stroke
Subacute stage (less than 4 weeks)

Exclusion Criteria:

Major active neurological disease or psychiatric disease
A history of seizure
Metallic implants in their brain

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

First-ever stroke patients at subacute stage.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided