Status Approved
First Submitted Date
2018/05/09
Registered Date
2018/07/13
Last Updated Date
2018/06/11
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0003001 |
|---|---|
| Unique Protocol ID | RM17-13 |
| Public/Brief Title | Decreased postural balance in back pain patients with lumboscaral radiculopathy |
| Scientific Title | Decreased postural balance in back pain patients with lumboscaral radiculopathy |
| Acronym | |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| 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 | RM17-13 |
| Approval Date | 2017-10-23 |
| Institutional Review Board Name | Bundan Jesaeng Institutional Review Board |
| Institutional Review Board Address | 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do |
| Institutional Review Board Telephone | 031-779-5061 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Seo Yeon Yoon |
| Title | Dr. |
| Telephone | +82-31-779-0627 |
| Affiliation | Bundang Jesaeng Hospital |
| Address | 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do |
| Contact Person for Public Queries | |
| Name | Seo Yeon Yoon |
| Title | Dr. |
| Telephone | +82-31-779-0627 |
| Affiliation | Bundang Jesaeng Hospital |
| Address | 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do |
| Contact Person for Updating Information | |
| Name | Seo Yeon Yoon |
| Title | Dr |
| Telephone | +82-31-779-0627 |
| Affiliation | Bundang Jesaeng Hospital |
| Address | 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Recruiting | |
| Date of First Enrollment | 2017-11-01 Actual | |
| Target Number of Participant | 40 | |
| Primary Completion Date | 2018-06-30 , Anticipated | |
| Study Completion Date | 2018-06-30 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Bundang Jesaeng Hospital | |
| Recruitment Status | Recruiting | |
| Date of First Enrollment | 2017-11-01 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Bundang Jesaeng Hospital |
| Organization Type | Medical Institute |
| Project ID | RM17-13 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Bundang Jesaeng Hospital |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | Balance control is an important skill required to successfully perform gait and activitis of daily living, and various factors such as visual, auditory, vestibular, proprioceptive, positional, muscle strength, and cognitive functions are involved in balance control. Decrease in balance ability is reported in 83% of patients after acute stroke. Decreases in the ability to balance control are associated with gait problems and increased risk of falls. In a recent study, osteoporosis has been associated with the balance ability. 'Tetrax' is a device that objectively evaluates the balance ability and has been widely used in previous studies.Therefore, the objective of this study is to compare differences of balance ability between back pain with lumbosacral(LS) radiculopathy and back pain without LS radiculopathy by using posturography,‘Tetrax’ |
|---|
8. Study Design
| Study Type | Observational Study |
|---|---|
| Observational Study Model | Case-control |
| Time Perspective | Prospective |
| Target Number of Participant | 40 |
| Cohort/Group Number | 2 |
|
Cohort/ Group 1 |
Cohort/Group Label back pain parients with lumbosacral radiculopathy |
|
Cohort/Group Description Balance ability will be measurd for patients who are referred for electromyography due to back pain and diagnosed with lumbosacral radiculopathy using 'Tetrax'. Evaluation parameters include fall riks, stability index, weight distribution index. |
|
|
Cohort/ Group 2 |
Cohort/Group Label back pain parients without lumbosacral radiculopathy |
|
Cohort/Group Description Balance ability will be measurd for patients who are referred for electromyography due to back pain and not diagnosed with lumbosacral radiculopathy using 'Tetrax'. Evaluation parameters include fall riks, stability index, weight distribution index. |
|
| Biospecimen Collection & Archiving |
Not collect nor Archive |
| Biospecimen Description |
9. Subject Eligibility
| Study Population Description | Patients who are referred for electromyography due to back pain |
|---|---|
| Sampling Method | non-probability sampling |
| Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M54.16)Radiculopathy, lumbar region |
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 19Year~No Limit |
|
|
Description Patients who are referred for electromyography due to back pain and diagnosed with lumbosacral radiculopathy |
|
| Exclusion Criteria |
Patients with disease of the vestibular apparatus, severe visual disturbance, peripheral neuropathy, impaired cognition, severe osteoarthritis and cavus foot were excluded from the study |
| Healthy Volunteers | No |
10. Outcome Measure(s)
| Type of Primary Outcome | Not applicable | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Fall risk |
|
| Timepoint | Same day with electromyography |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Weight distribution index |
|
| Timepoint | Same day with electromyography |
|
| Secondary Outcome(s) 2 | ||
| Outcome | Stability index |
|
| Timepoint | Same day with electromyography |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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