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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916924
• Other study ID #: 2021-05-018
• Status: Recruiting
• Start date: March 28, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Bundang CHA Hospital
• Contact: Hyun Jung Oh
• Phone: +82 031 780 6003
• Email: a210525[@]chamc.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Stroke

Intervention

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
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

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, CHA Bundang Medical Center	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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