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

NCT05908994 | Unknown

• 1 other identifier: 2021-05-026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Health Behavior

Outcome Measures

Primary Outcomes (1)

• Changes in motion analysis

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

  Change from baseline to 6 months, 12 months, 18 months and 24 months

Secondary Outcomes (30)

• Changes in X-ray radiography

  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 magnetic resonanace imaging (MRI)

  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 motricity index (MI)

  Change from baseline to 6 months, 12 months, 18 months and 24 months

Interventions

Examination OTHER

Exmainations including imaging, neurophysiological, kinetic and kinematic measurmetns. Behavioral assessments

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stroke patients and healthy voluteers

You may qualify if:

• Adults over 20 years of age
• More than 1 month after onset of stroke

You may not qualify if:

• 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.)
• 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
• 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.)

Sponsors & Collaborators

• Bundang CHA Hospital: lead

Study Sites (1)

Department of Rehabilitation Medicine, CHA Bundang Medical Center

Seongnam, 13496, South Korea

RECRUITING

Related Publications (1)

• Bak SY, Chung EH, Kim H, Shin S, Jeon H, Kim M. Comparison of gait parameters between patients with chronic stroke at different ambulation levels and healthy adults: a prospective observational study. BMC Sports Sci Med Rehabil. 2025 Dec 1;18(1):9. doi: 10.1186/s13102-025-01444-4.

  PMID: 41327370 DERIVED

MeSH Terms

Conditions

Stroke; Health Behavior

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Central Study Contacts

Hyun Jung Oh, Bachelor's degree

CONTACT

+82 031 780 6003; a210525@chamc.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 18, 2023
• Study Start: October 6, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)