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  • Status : Approved
    • First Submitted Date : 2019/05/28
    • Registered Date : 2019/06/13
    • Last Updated Date : 2019/06/12
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1. Background

Background Information
CRIS
Registration Number
KCT0004059 
Unique Protocol ID 05-2019-042 
Public/Brief Title The effect of pressure biofeedbakc during wall one leg standing 
Scientific Title The effects of pressure biofeedback during wall one leg standing on lumbopelvic alignment and trunk and hip muscle activity  
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

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number 05-2019-042 
Approval Date 2019-04-23 
Institutional Review Board  
Name Pusan national university yangsan hospital institution review board 
Address 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do 
Telephone 055-360-3854 
Data Monitoring Committee    

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Soo yong kim 
Title PhD 
Telephone +82-55-360-4214 
Affiliation Inje University 
Address INJE University 607 Obang-dong, Gimhae-si, 
Contact Person for Public Queries
Name Soo yong kim 
Title PhD 
Telephone +82-55-360-4214 
Affiliation Inje University 
Address INJE University 607 Obang-dong, Gimhae-si, 
Contact Person for Updating Information
Name Soo yong kim 
Title PhD 
Telephone +82-55-360-4214 
Affiliation Inje University 
Address INJE University 607 Obang-dong, Gimhae-si, 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2019-05-16 , Actual
Target Number of Participant 30
Primary Completion Date 2019-12-31 , Anticipated
Study Completion Date 2019-12-31 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Inje University 
Recruitment Status Recruiting  
Date of First Enrollment 2019-05-16 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Inje University 
Organization Type University  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Inje University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary One leg stand is to maintain balance while standing on one leg, this is used to evaluate posture stability, function of gluteus medius, and motion deviation, as well as to strengthen muscle strength in hip joint muscles, such as gluteus medius.
The gluteus medius acts as a stabilizing muscle on the coronal and horizontal planes while standing on one leg . However, during one leg standing, lateral pelvic tilting or tilting of the torso can occur, which may reduce the use of gluteus medius and increase the action of the quadratus lumborum by compensating action. The action of excessive quadratus lumborum muscle can be linked to back pain. Therefore, there is a need for a method capable of performing a ong leg stadning without compensating the back-pelvis.
Wall ong leg stadning can prevent the lumbo-pelvic compensating action. However, this method can also suppress the use of famine in the gluteus medius of the supporting side due to excessive support of the shoulder of the non - supporting side during the standing of one leg. Thus, if you visually identify changes in shoulder pressure on the non-supporting side that press against the wall while standing on one leg, you can prevent excessive reliance on the wall and increase the participation of the gluteus medius in the supporting leg. However, few studies have investigated the lumbo-pelvic alignment and the activation of the muscles of the trunk muscles in the visual pressure feedback feedback during one leg stance.
The purpose of this study was to measure lumbopelvic alignment and changes in trunk and hip joint muscle muscle activation when visual feedback was applied wall one leg standing on healthy normal subjects.
The hypothesis was that the visual pressure biofeedback would have less change in lumbopelvic alignment and greater chane in trunk and hip joint muscle activation than without visual pressure biofeedback.  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Case-control 
Time Perspective Cross-sectional    
Target Number of Participant 30
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
Control group 
Cohort/Group
Description
Hold the one leg stadning for 5 seconds while being supported by the non-supporting shoulder on the wall. During wall one leg standing, the lumbopelvic alignment and muscle activation of the trunk and hip joint muscle are evaluate. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
Visual Pressure Biological Feedback Using a Wall Stand 1 
Cohort/Group
Description
Place the non-supporting shoulder on a pressure gauge located on the wall and hold the one leg standing for 5 seconds, keeping the change in shoulder pressure less than 50%. During wall one leg standing, the lumbopelvic alignment and muscle activation of the trunk and hip joint muscle are evaluate. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 3
Cohort/Group
Label
Visual Pressure Biological Feedback Using a Wall Stand 
Cohort/Group
Description
Place the unsupported shoulder on a pressure gauge on the wall and hold one leg for 5 seconds to minimize the change in shoulder pressure. During wall one leg standing, the lumbopelvic alignment and muscle activation of the trunk and hip joint muscle are evaluate. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description healthy subects  
Sampling Method Non-probability sampling-convenience sampling  
Condition(s)/Problem(s) * Not Applicable
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 60 Year
Description -Those who have not developed musculoskeletal or nervous system diseases that may affect the one leg standing within the last 3 months
- who have no mental problems
- Those who can stand one leg for more than 10 seconds  
Exclusion Criteria - Those who can not exercise a leg without compensation
- Those with lower back pain or back pain.
- Persons with cognitive and communication disorders
- Those with cardiac arrestor and heart disease
- pregnant woman  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome femoral pelvic angle 
Timepoint Measured during three types of wall one leg standing exercise for 5 seconds 
Secondary Outcome(s) 1 
Outcome trunk lean 
Timepoint Measured during three types of wall one leg standing exercise for 5 seconds 
Secondary Outcome(s) 2 
Outcome activation of trunk and hip muscle activation 
Timepoint Measured during three types of wall one leg standing exercise for 5 seconds 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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