Status Approved
First Submitted Date
2020/09/15
Registered Date
2020/10/08
Last Updated Date
2020/09/25
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0005455 |
|---|---|
| Unique Protocol ID | 2020-03-028 |
| Public/Brief Title | Clinical analysis of peripheral facial palsy in the elderly |
| Scientific Title | Clinical analysis of peripheral facial palsy in the elderly |
| Acronym | |
| MFDS Regulated Study | No |
| IND/IDE Protocol | |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | 2020-03-028-001 |
| Approval Date | 2020-04-28 |
| Institutional Review Board Name | Chosun University Hospital, Institutional Review Board |
| Institutional Review Board Address | 365, Pilmun-daero, Dong-gu, Gwangju |
| Institutional Review Board Telephone | 062-220-3268 |
| Data Monitoring Committee |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Sung Il Cho |
| Title | Prof. |
| Telephone | +82-62-220-3207 |
| Affiliation | Chosun University Hospital |
| Address | 365 Pilmun-daero, Dong-gu, Gwangju |
| Contact Person for Public Queries | |
| Name | Sung Il Cho |
| Title | Prof. |
| Telephone | +82-62-220-3207 |
| Affiliation | Chosun University Hospital |
| Address | 365 Pilmun-daero, Dong-gu, Gwangju |
| Contact Person for Updating Information | |
| Name | Sung Il Cho |
| Title | Prof. |
| Telephone | +82-62-220-3207 |
| Affiliation | Chosun University Hospital |
| Address | 365 Pilmun-daero, Dong-gu, Gwangju |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2020-04-28 Actual | |
| Target Number of Participant | 30 | |
| Primary Completion Date | 2020-06-30 , Actual | |
| Study Completion Date | 2020-06-30 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Chosun University Hospital | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2020-04-28 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Chosun University Hospital |
| Organization Type | Medical Institute |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Chosun University Hospital |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | The elderly frequently exhibit comorbidities, such as diabetes or hypertension, and the relatively low immunity of the elderly compared to the younger adults is likely to entail different clinical outcomes for facial palsy. The abnormal facial movements in the elderly may restrict social activities and increase the frequency of depression. However, no study has examined the clinical characteristics of facial palsy in the elderly. Thus, this study investigated the clinical characteristics and therapeutic outcomes of peripheral facial palsy in the elderly aged ≥ 60 years. |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Others |
| Time Perspective | Retrospective |
| Target Number of Participant | 30 |
| Cohort/Group Number | 1 |
|
Cohort/ Group 1 |
Cohort/Group Label Patients aged ≥ 60 years and who were diagnosed with acute facial palsy at the present hospital |
|
Cohort/Group Description This study included 30 patients aged ≥ 60 years and who were diagnosed with acute facial palsy at the present hospital. The participants who did not agree for the regular follow-ups and whose systemic health was so poor that the grade of facial palsy could not be accurately assessed were excluded. The clinical characteristics of the patients, including the age, sex, etiology, grade of facial palsy, comorbidity, treatment methods, and recovery, were investigated retrospectively. |
|
| Biospecimen Collection & Archiving |
Not collect nor Archive |
| Biospecimen Description |
9. Subject Eligibility
| Study Population Description | Patients aged ≥ 60 years and who were diagnosed with acute facial palsy at the present hospital |
|---|---|
| Sampling Method | Non-probability sampling |
| Condition(s)/Problem(s) |
* (G00-G99)Diseases of the nervous system (G51.0)Bell’s palsy Facial Paralysis, aged |
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 60Year~100Year |
|
|
Description Patients aged ≥ 60 years and who were diagnosed with acute facial palsy at the present hospital |
|
| Exclusion Criteria |
The participants who did not agree for the regular follow-ups and whose systemic health was so poor that the grade of facial palsy could not be accurately assessed were excluded. |
| Healthy Volunteers |
10. Outcome Measure(s)
| Type of Primary Outcome | Not applicable | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | The grade of facial palsy |
|
| Timepoint | 6 weeks, 3 months |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Recovery rate |
|
| Timepoint | 6 weeks, 3 months |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Yes |
|---|---|
| Time of Sharing | 2021. 1 |
| Way of Sharing | Available on Request
(chosi@chosun.ac.kr) |
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