A Study for Collecting Data on the Motion Analysis of Stroke Patients

NCT05916924 | Unknown

• 1 other identifier: 2021-05-018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

An observational study to collect (functional evaluation and daily motion) for composing 3D kinematic data that will be the basis for setting rehabilitation goal points for each stroke patient and developing virtual reality rehabilitation contents via video shooting.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Changes in motion analysis in gait spatiotemporal parameters

  Motion analysis is a process of measuring and evaluating gait function in gait spatiotemporal parameter, gait speed (m/s)

  Change from baseline to 1 day and 14 days

• Changes in motion analysis in gait spatiotemporal parameters

  Motion analysis is a process of measuring and evaluating gait function in gait spatiotemporal parameter, stride length (cm)

  Change from baseline to 1 day and 14 days

• Changes in motion analysis in kinematic parameters

  Motion analysis is a process of measuring and evaluating gait function in kinematic parameter, sagittal angle (degree)

  Change from baseline to 1 day and 14 days

Secondary Outcomes (3)

• Changes in manual muscle test (MMT)

  Change from baseline to 1 day and 14 days

• Changes in motricity index (MI)

  Change from baseline to 1 day and 14 days

• Changes in berg balance scale (BBS)

  Change from baseline to 1 day and 14 days

Interventions

Collection of clinical data including manual muscle test (MMT), range of motion (ROM), Fugl-Meyer assessment (FMA), berg balance scale (BBS) and kinetic data via video shooting OTHER

Collection of clinical data including manual muscle test (MMT), range of motion (ROM), Fugl-Meyer assessment (FMA), berg balance scale (BBS) and kinetic data via video shooting

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stroke patients

You may qualify if:

• 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

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 without 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 studies or have participated in other 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

MeSH Terms

Conditions

Stroke

Interventions

2-methylcyclopentadienyl manganese tricarbonyl; Range of Motion, Articular

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Hyun Jung Oh

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 24, 2023
• First Posted: June 23, 2023
• Study Start: March 28, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)