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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Hyun Jung Oh; Phone Number: +82 031 780 6003; Email: a210525@chamc.co.kr

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of, 13496
    • Recruiting
    • Department of Rehabilitation Medicine, CHA Bundang Medical Center
    • Contact: MinYoung Kim, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Stroke patients

Description

1. Inclusion criteria

1. Over 20 years of age
2. More than 1 month after onset of stroke
3. 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

1. Patients who correspond to one or more of the following cannot participate in the study.
2. Patients with systemic infectious symptoms at the time of participation in the study
3. In the case of a person with impaired ability to consent (less than 10 points on the MMSE), a person without a guardian
4. 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
5. 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.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in manual muscle test (MMT)	MMT is a process of the evaluating the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance in score	Change from baseline to 1 day and 14 days
Changes in motricity index (MI)	MI is a process of the evaluating the function and strength of upper, lower extremities and trunk in score	Change from baseline to 1 day and 14 days
Changes in berg balance scale (BBS)	BBS is a measurement of balancing function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total score = 56	Change from baseline to 1 day and 14 days

Collaborators and Investigators

• Sponsor: Bundang CHA Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2021-05-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No