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Evaluation of spasticity using mechanomyography in patients with brain lesion

Status Approved

  • First Submitted Date

    2017/06/19

  • Registered Date

    2017/07/21

  • Last Updated Date

    2017/07/20

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002385
    Unique Protocol ID YWMR-15-8-073
    Public/Brief Title Evaluation of spasticity using mechanomyography in patients with brain lesion
    Scientific Title Evaluation of spasticity using mechanomyography in patients with brain lesion
    Acronym mechanomyography -> MMG
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number YWMR-15-8-073
    Approval Date 2015-10-08
    Institutional Review Board Name Wonju severance christian hospital institutional review board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name sung hoon Kim
    Title Prof
    Telephone +82-33-741-1707
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address GANGWON-DO, WONJU-SI. ILSAN-RO 20
    Contact Person for Public Queries
    Name Sangwoo JUN
    Title Ph.D. candidate
    Telephone +82-33-741-1707
    Affiliation Yonsei University
    Address SEOUL-SI, SEODAEMUN-GU, YONSEI-RO 50-1
    Contact Person for Updating Information
    Name Sangwoo JUN
    Title Ph.D. candidate
    Telephone +82-33-741-1707
    Affiliation Yonsei University
    Address SEOUL-SI, SEODAEMUN-GU, YONSEI-RO 50-1
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2015-12-03 Actual
    Target Number of Participant 15
    Primary Completion Date 2016-10-04 , Actual
    Study Completion Date 2016-10-04 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University, Wonju Severance Christian Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2015-12-03 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Yonsei University, Wonju Severance Christian Hospital
    Organization Type Medical Institute
    Project ID YWMR-15-8-073
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University, Wonju Severance Christian Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The MMG signals reflect the characteristics of the physical movement of the muscles in various situations. Based on the acceleration sensor, external noise and frequency interference are noted. And the production price is a low-cost measurement device. Measure the mechanical vibration characteristics of the VL and ST by placing a constant motion on the patient. Perform a pendulum check on the patient to measure the ' Relaxation Index '. Measure the electrical properties produced by the patient using ' Electromyography '. Analyse the above data to demonstrate the validity of the new clinical indicators in spasticity.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Prospective  
    Target Number of Participant 15
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Test group/control group

    Cohort/Group Description

    - Patient who is diagnosed with cerebral palsy and trauma
    - Patient with no abnormal bone disease in his knee joints
    - Patient who understands and carries out the instructions
    - patients who have suffered at least six months after the outbreak
    After registering the patient for the above conditions, measure the data using the EMG, MMG, and pendulum motion meter.
    The data is measured in the joint of the leg muscles in which the paralysis occurred and measure the data from the knee joint on the other leg.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    - Patient who is diagnosed with cerebral palsy and trauma
    - Patient with no abnormal bone disease in his knee joints
    - Patient who understands and carries out the instructions
    - patients who have suffered at least six months after the outbreak
    Sampling Method
    Screening and registered in the order of admission, then Random assignment
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I64)Stroke, not specified as haemorrhage or infarction 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    - Patient who is diagnosed with cerebral palsy and trauma
    - Patient with no abnormal bone disease in his knee joints
    - Patient who understands and carries out the instructions
    - patients who have suffered at least six months after the outbreak
    Exclusion Criteria
    - patients with less than 6 months of experience
    - Patient who is unable to extension and contraction
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome clinical-equivalence
    Primary Outcome(s) 1
    Outcome
    Relaxation Index, Electromyography, Mechanomyography
    Timepoint
    Immediately
    Secondary Outcome(s) 1
    Outcome
    Modified ashworth scale
    Timepoint
    Immediately
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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