Back to resultsEffects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent SubjectS
Primary Purpose
Pelvic Floor Muscle Weakness, Stress Urinary Incontinence, Pelvic Asymmetry
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neuromuscual realigning exercise
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Muscle Weakness
Eligibility Criteria
Inclusion Criteria:
Positive Ober's test
Exclusion Criteria:
- pelvic/low back pain in previous 12 months
Sites / Locations
- University of North GeorgiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
control
Arm Description
Outcomes
Primary Outcome Measures
bladder base elevation
the ability to contract pelvic floor muscle measured as bladder base elevation by transabdominal ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT03975686
First Posted
May 31, 2019
Last Updated
March 30, 2020
Sponsor
University of North Georgia
1. Study Identification
Unique Protocol Identification Number
NCT03975686
Brief Title
Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent SubjectS
Official Title
Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent Subjects: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
August 29, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this research study is to investigate the effect of a new neuromuscular approach for correcting pelvic alignment and improving pelvic floor muscle function. Investigators hypothesized that this approach would be significantly superior than no intervention to improve the ability of pelvic floor muscle contraction, measured by transabdominal sonography as bladder base elevation. Participants will be randomized to the intervention and control groups. while intervention group will receive five supervised sessions of pelvic realigning exercises, the control group will receive no intervention. Bladder base elevation will be measured as an indicator of pelvic floor muscle function, before and after one week intervention in both control and intervention groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Muscle Weakness, Stress Urinary Incontinence, Pelvic Asymmetry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
neuromuscual realigning exercise
Intervention Description
neuromuscular realigning exercise
Primary Outcome Measure Information:
Title
bladder base elevation
Description
the ability to contract pelvic floor muscle measured as bladder base elevation by transabdominal ultrasound
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Positive Ober's test
Exclusion Criteria:
pelvic/low back pain in previous 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad R Nourbakhsh, professor
Phone
7068641766
Email
reza.nourbakhsh@ung.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahshid A Chehrehrazi, Student
Organizational Affiliation
University of North Georgia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad R Nourbakhsh, professor
Organizational Affiliation
University of North Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Georgia
City
Dahlonega
State/Province
Georgia
ZIP/Postal Code
30533
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent SubjectS
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