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Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent SubjectS

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ClinicalTrials.gov Identifier: NCT03975686
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad(Reza) Nourbakhsh, University of North Georgia

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.

Condition or disease Intervention/treatment Phase
Pelvic Floor Muscle Weakness Stress Urinary Incontinence Pelvic Asymmetry Other: neuromuscual realigning exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent Subjects: A Randomized Control Trial
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention Other: neuromuscual realigning exercise
neuromuscular realigning exercise

No Intervention: control



Primary Outcome Measures :
  1. bladder base elevation [ Time Frame: one week ]
    the ability to contract pelvic floor muscle measured as bladder base elevation by transabdominal ultrasound



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Positive Ober's test

Exclusion Criteria:

  • pelvic/low back pain in previous 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975686


Contacts
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Contact: Mohammad R Nourbakhsh, professor 7068641766 reza.nourbakhsh@ung.edu

Locations
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United States, Georgia
University of North Georgia Recruiting
Dahlonega, Georgia, United States, 30533
Sponsors and Collaborators
University of North Georgia
Investigators
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Study Director: Mahshid A Chehrehrazi, Student University of North Georgia
Principal Investigator: Mohammad R Nourbakhsh, professor University of North Georgia

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Responsible Party: Mohammad(Reza) Nourbakhsh, Full Professor, University of North Georgia
ClinicalTrials.gov Identifier: NCT03975686     History of Changes
Other Study ID Numbers: UNorthGeorgia
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Muscle Weakness
Paresis
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes