Clinical trial NCT05908994: A Study for the Collection of Clinical Data for Stroke Patients and Healthy Subjects
Official title: A Study for the Collection of Clinical Data for Stroke Patients and Healthy Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Health Behavior
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients and healthy voluteers

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.


Eligibility criteria: 1. For stroke patients 1) 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.)
2. For healthy voluteers 1) Inclusion Criteria:

   * Over 20 years of age
   * A person who is performing an independent daily life
   * A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing a detailed explanation of this study and fully understanding it

     2) Exclusion criteria:
   * Patients who correspond to one or more of the following cannot participate in the study.
   * MMSE score less than 20 points (from 19 points onwards excluded from study)
   * Those who remain disabled due to brain disease (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
   * 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.)

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