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
CRIS Registration Number |
KCT0002385 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Yonsei University, Wonju Severance Christian Hospital |
Organization Type | Medical Institute |
Project ID | YWMR-15-8-073 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University, Wonju Severance Christian Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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
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 |
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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)
Type of Primary Outcome | clinical-equivalence | |
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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
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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