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

Sponsor

University of North Georgia (Other)

Overall Status

Unknown status

CT.gov ID

NCT03975686

Collaborator

(none)

Enrollment

Location

Arms

2.9

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Muscle Weakness Stress Urinary Incontinence Pelvic Asymmetry	Other: neuromuscual realigning exercise	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Jul 30, 2020

Anticipated Study Completion Date :

Aug 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention	Other: neuromuscual realigning exercise neuromuscular realigning exercise
No Intervention: control

Arm

Intervention/Treatment

Experimental: intervention

Other: neuromuscual realigning exercise

neuromuscular realigning exercise

No Intervention: control

Outcome Measures

Primary Outcome Measures

bladder base elevation [one week]
the ability to contract pelvic floor muscle measured as bladder base elevation by transabdominal ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Positive Ober's test

Exclusion Criteria:

pelvic/low back pain in previous 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Georgia	Dahlonega	Georgia	United States	30533

Sponsors and Collaborators

University of North Georgia

Investigators

Study Director: Mahshid A Chehrehrazi, Student, University of North Georgia
Principal Investigator: Mohammad R Nourbakhsh, professor, University of North Georgia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammad(Reza) Nourbakhsh, Full Professor, University of North Georgia

ClinicalTrials.gov Identifier:

NCT03975686

Other Study ID Numbers:

UNorthGeorgia

First Posted:

Jun 5, 2019

Last Update Posted:

Mar 31, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscle Weakness

Urinary Incontinence

Urinary Incontinence, Stress

Study Results

No Results Posted as of Mar 31, 2020