Effects of Neuromuscular Pelvic Realigning Exercises on P... | NCT03975686

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

NCT03975686

Sponsor

University of North Georgia

Status

Unknown status

Last Update Posted

Mar 31, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Pelvic Floor Muscle Weakness
Stress Urinary Incontinence
Pelvic Asymmetry

Interventions

neuromuscual realigning exercise

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Estimated

Primary Completion Date

Jul 30, 2020Estimated

Completion Date

Aug 29, 2020Estimated

First Submitted Date

May 31, 2019

First Submission Date that Met QC Criteria

Jun 3, 2019

First Posted Date

Jun 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2020

Last Update Posted Date

Mar 31, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammad(Reza) Nourbakhsh, Full Professor, University of North GeorgiaPrincipal Investigator

Lead Sponsor

University of North GeorgiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental		Other: neuromuscual realigning exercise
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neuromuscual realigning exercise	Other	neuromuscular realigning exercise	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bladder base elevation	the ability to contract pelvic floor muscle measured as bladder base elevation by transabdominal ultrasound	one week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive Ober's test

Exclusion Criteria:

pelvic/low back pain in previous 12 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad R Nourbakhsh, professor	Contact	7068641766		reza.nourbakhsh@ung.edu

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Georgia	Recruiting	Dahlonega	Georgia	30533	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided