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

Sponsor
Bundang CHA Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05916924
Collaborator
(none)
100
Enrollment
1
Location
33.1
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Study for Collecting Data on the Motion Analysis of Stroke Patients
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Changes in motion analysis in gait spatiotemporal parameters [Change from baseline to 1 day and 14 days]

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

  2. Changes in motion analysis in gait spatiotemporal parameters [Change from baseline to 1 day and 14 days]

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

  3. Changes in motion analysis in kinematic parameters [Change from baseline to 1 day and 14 days]

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

Secondary Outcome Measures

  1. Changes in manual muscle test (MMT) [Change from baseline to 1 day and 14 days]

    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

  2. Changes in motricity index (MI) [Change from baseline to 1 day and 14 days]

    MI is a process of the evaluating the function and strength of upper, lower extremities and trunk in score

  3. Changes in berg balance scale (BBS) [Change from baseline to 1 day and 14 days]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  1. Inclusion criteria

  2. Over 20 years of age

  3. More than 1 month after onset of stroke

  4. 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

  5. Exclusion criteria

  6. Patients who correspond to one or more of the following cannot participate in the study.

  7. Patients with systemic infectious symptoms at the time of participation in the study

  8. In the case of a person with impaired ability to consent (less than 10 points on the MMSE), a person without a guardian

  9. 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

  10. 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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Rehabilitation Medicine, CHA Bundang Medical Center Seongnam Korea, Republic of 13496

Sponsors and Collaborators

  • Bundang CHA Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MinYoung Kim, MD, PhD, Principle investigator, Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT05916924
Other Study ID Numbers:
  • 2021-05-018
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Jun 23, 2023