A Study for the Collection of Clinical Data for Stroke Patients and Healthy Subjects

Bundang CHA Hospital1 site in 1 country100 target enrollmentOctober 6, 2021

ConditionsStroke Health Behavior

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Bundang CHA Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: Changes in motion analysis
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aimes to medical data, musculoskeletal data and functional data over time of stroke patients and healthy subjects to compared the clinical differences between stroke and healthy subjects.

Registry

clinicaltrials.gov

Start Date

October 6, 2021

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bundang CHA Hospital

Responsible Party

Principal Investigator

MinYoung Kim, MD, PhD

Principle investigator

Bundang CHA Hospital

Eligibility Criteria

Inclusion Criteria

•Adults over 20 years of age
•More than 1 month after onset of stroke
•After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions 2) Exclusion criteria:
•Patients who correspond to one or more of the following cannot participate in the study.
•Patients with systemic infectious symptoms at the time of participation in the study
•In the case of a person with impaired ability to consent (less than 10 points on the MMSE), a person who is not accompanied by a guardian
•Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
•Other cases where the researcher judges that participation in this study is not suitable(Patients who are participating in other clinical trials or studies, or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)
•For healthy voluteers 1) Inclusion Criteria:
•Over 20 years of age

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Changes in motion analysis

Time Frame: Change from baseline to 6 months, 12 months, 18 months and 24 months

Motion analysis is a process of measuring and evaluating gait function in kinetic and kinematic parameters

Secondary Outcomes

Changes in Fugl-meyer assessement (FMA)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in X-ray radiography(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in motor assessment scale (MAS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in magnetic resonanace imaging (MRI)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in motricity index (MI)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in Gait rite(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in time up and go test (TUG)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in computed tomogrphy (CT)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in manual muscle test (MMT)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in range of motion (ROM)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in berg balance scale (BBS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in trunk impairment scale (TIS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in functional ambulatory category (FAC)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in action research arm test (ARAT)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in fuctional independence meausure (FIM)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in modified barthel-index (MBI)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in national institute of health care stroke scale (NIHSS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in stroke specific quality of life (SS-QoL)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in Korean version of Montreal cognitive assessment (K-MoCA)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in Korean version of mini-mental state examination (K-MMSE)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in global deterioration scale (GDS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in Oxford cognitive screen (OCS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in clinical dementia rating (CDR)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in geriatric depression scale (GDS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in stroop test(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in evoked potentials (EP)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in Korean version of Wechsler adult intelligence scale 4th edition (K-WAIS-IV)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in Rey-kim test(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in digit span test(Change from baseline to 6 months, 12 months, 18 months and 24 months)
Changes in electroencephalogrphy (EEG)(Change from baseline to 6 months, 12 months, 18 months and 24 months)