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  • Status : Approved
    • First Submitted Date : 2017/12/04
    • Registered Date : 2018/03/09
    • Last Updated Date : 2018/02/10
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1. Background

Background Information
CRIS
Registration Number
KCT0002728 
Unique Protocol ID INJE 2017-08-019-001 
Public/Brief Title Effects of indirect pelvic floor muscle activation using a pressure sensor on trunk muscle activity in sitting position 
Scientific Title Effects of indirect pelvic floor muscle activation using a pressure sensor on trunk muscle activity in sitting position  
Acronym  
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 INJE 2017-08-019-001 
Approval Date 2017-10-10 
Institutional Review Board  
Name Inje university institutional Review Board 
Address 50834, 197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea 
Telephone 055-333-5765 
Data Monitoring Committee    

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Jae-seop Oh 
Title PhD 
Telephone +82-55-320-3849 
Affiliation Inje University 
Address 197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea 
Contact Person for Public Queries
Name Eun-Joo Jung 
Title BHSc 
Telephone +82-55-320-3849 
Affiliation Inje University 
Address 197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea 
Contact Person for Updating Information
Name Eun-Joo Jung 
Title BHSc 
Telephone +82-55-320-3849 
Affiliation Inje University 
Address 197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2018-03-01 , Anticipated
Target Number of Participant 15
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study Site Inje University 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2018-03-01 , Anticipated

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 Pelvic floor muscle is recognized as important in the treatment of common musculoskeletal disorders experienced by women, such as incontinence and back pain. The pelvic floor consists of muscles, ligaments and fascia structures that extend over the lower part of the pelvis. Pelvic floor muscle support depends on the anatomical location of the muscle, completeness of the fascia (passive support), and muscle activation (active support). This structural change or inappropriate function causes various diseases such as pelvic organ prolapse, sexual dysfunction and urinary incontinence. Women who are suffering from pelvic floor problems are often advised of the "Kegel exercise" because they can prevent or treat all disorders through programs that improve the strength and coordination of pelvic floor muscles. However, although the pelvic contraction method has provided a lot of information, it generally tends not to shrink the pelvic floor. Functional training of the pelvic floor can prevent and treat various problems caused by various physical problems and muscular weakness in the end of life.

The pelvic floor is known to increase the stability of the trunk by increasing the abdominal pressure due to co-contraction with the muscles of the transverse abdominal muscula (TrA) and the multi-tangential muscles. The internal and external abdominal oblique muscles (IO) and external abdominal oblique muscle (EO) of the trunk play a role in maintaining lumbar rotation, load and balance Transverse abdominal muscula (TrA), dorsal torsion to the back, diapharagm to the upper side, and lower pelvic floor to play an important role in the stability of the trunk. Multifocal muscle is the nearest posture and stabilizing muscle, which acts primarily in the vertebral movements segment. The myofacial roots provide stiffness to strengthen the dynamic stability of the lumbar vertebrae with mutual activation with the tibialis anterior and provide tension to the thoracic lumbar fascia to maintain the pressure of the abdomen. The transversus muscles are most commonly required during exercise, the pelvic stabilization is better, and the strength of the pelvic floor muscles during exercise is enhanced. Joint activation of the pelvic floor muscles and transversus muscles increases the dysflexion and supports the thoracolumbar fascia and pelvic internal. However, pelvic floor muscles are 'invisible muscles' as can be seen from the invisible muscles that have many difficulties to shrink it.

Panjabi defines a neutral zone and defines the trunk stabilization movement to be performed at a neutral position. The neutral position of the hip, pelvis, and hip joints is to prevent the sacrum from engulfing so that the symphysis pubic area is level with the two proximal bones (without posterior or anterior tilt of the pelvis) Do not push the torsion bar too deeply. When examining, the optimal posture for bringing the pelvic girdle and lumbar vertebrae to neutral is sitting position. The activity of the pelvic floor muscle in sitting position has been reported to fall further from women with incontinence.

Patrick, Lia Ferla et al. use an invasive EMG biofeedback method for activation of the pelvic floor muscles, but this is not a training appropriate to the situation in Korea. An appropriate feedback method should be devised for stabilization of the trunk including pelvic floor muscle, but there is no effective method in the clinical field. Recently, biofeedback training has been used as a method of using pressure sensor in stabilization exercise. However, it is a method to provide information directly to the patient using pressure biofeedback tool Biofeedback.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Supportive Care    
Phase Not applicable 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Others (exercise with Pressure Biofeedback Unit)
Intervention Description Preparation before measurement
 - general characteristics of the subjects (height, age, body weight)
 - The surface EMG is attached to the attachment point of multi-tangential, extrinsic, transverse / internal, and rectus abdominis muscle.
To normalize the EMG data, MVIC was performed on the multifractor, exotropia, transverse / internal and medial rectus muscles, respectively. Each MVIC operation measures 5 seconds and measures 3 times and provides 3 minutes of rest between measurements. After collecting the measured values ​​for the middle 3 seconds for each muscle, it is used for the normalization analysis by using the average data for three times of operation. Measurement of trunk muscle strength during pelvic floor contraction without biofeedback in sitting position
 Starting position: In a sitting position, two legs are placed side by side, both arms are lightly dropped to the side of the pelvis, and the gaze is gazing at the front.
 The pelvic floor contraction is described as "breathing is as comfortable as usual, and shrink pelvic floor muscles as much as you can." Explain that contractions of the pelvic floor muscles without contractions of the abdomen, buttocks, and adductor muscles, The average isometric value is measured by measuring the maximum isometric contraction for 8 seconds, and a 3-minute rest period between each movement is used to reduce muscle fatigue. Measurement of trunk muscle strength during pelvic floor contraction - In order to minimize the compensatory action of the pelvis during sitting, the pelvis of the subject is controlled by the tester to maintain the neutral position. 10 minutes after sitting in the sitting position without using biofeedback pelvic floor contraction muscle strength during the measurement - 5 times each side We will provide a 3-minute break between each posture to prevent fatigue.  
Number of Arms
Arm 1 Arm Label Intervention Group 
Target Number of Participant 15 
Arm Type Experimental 
Arm Description - The surface EMG is attached to the attachment point of multi-tangential, extrinsic, transverse / internal, and rectus abdominis muscle. To normalize the EMG data, MVIC was performed on the multifractor, exotropia, transverse / internal and medial rectus muscles, respectively. Each MVIC operation measures 5 seconds and measures 3 times and provides 3 minutes of rest between measurements. After collecting the measured values ​​for the middle 3 seconds for each muscle, it is used for the normalization analysis by using the average data for three times of operation. Measurement of trunk muscle strength during pelvic floor contraction without biofeedback in sitting position Starting position: In a sitting position, two legs are placed side by side, both arms are lightly dropped to the side of the pelvis, and the gaze is gazing at the front. The pelvic floor contraction is described as "breathing is as comfortable as usual, and shrink pelvic floor muscles as much as you can." Explain that contractions of the pelvic floor muscles without contractions of the abdomen, buttocks, and adductor muscles, The average isometric value is measured by measuring the maximum isometric contraction for 8 seconds, and a 3-minute rest period between each movement is used to reduce muscle fatigue. Measurement of trunk muscle strength during pelvic floor contraction - In order to minimize the compensatory action of the pelvis during sitting, the pelvis of the subject is controlled by the tester to maintain the neutral position. 10 minutes after sitting in the sitting position without using biofeedback pelvic floor contraction muscle strength during the measurement - 5 times each side We will provide a 3-minute break between each posture to prevent fatigue. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the musculo-skeletal system and connective tissue
 
Rare Disease No
Inclusion
Criteria
Gender Female 
Age 20 Year ~ 80 Year
Description Healthy subjects without past and present pain  
Exclusion Criteria - Those with musculoskeletal and nervous system disorders for the past 6 months
  - Those with a history of back pain and surgery
  - Pregnant
  - Those with pain during test posture  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome Multifidus muslc activity 
Timepoint preintervention, intervention, postintervention 
Primary Outcome(s) 2 
Outcome Abdominal rectus muslc activity 
Timepoint preintervention, intervention, postintervention 
Primary Outcome(s) 3 
Outcome External oblique muslc activity 
Timepoint preintervention, intervention, postintervention 
Secondary Outcome(s) 1 
Outcome Transverse abdominal, Internal oblique muslc activity 
Timepoint preintervention, intervention, postintervention 

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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