Activating Transversus Abdominis Muscle | NCT04324242

Studies
Activating Transversus Abdominis Muscle

NCT04324242

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

Jun 12, 2020Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Low Back Pain
Rehabilitative Ultrasound
Spinal Stabilization

Interventions

abdominal hallowing maneuver

Countries

Turkey (Türkiye)

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

Apr 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

Apr 13, 2020Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Sep 15, 2020Estimated

First Submitted Date

Mar 24, 2020

First Submission Date that Met QC Criteria

Mar 26, 2020

First Posted Date

Mar 27, 2020Actual

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

Jun 11, 2020

Last Update Posted Date

Jun 12, 2020Actual

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

Transversus abdominis (TrA) is an important muscle for spinal stabilization. Abdominal draw-in maneuver (ADIM) is a method that selectively activates TrA without activating external oblique (EO) and internal oblique (IO) muscles. Individuals with low back pain may have some troubles to understand proper contraction of TrA. Therefore, to contract the TrA, two different feedback techniques have been used to instruct. In this observational study we aim to investigate the effects of two different biofeedback methods to teach patients the proper activation of TrA muscle using ADIM. We aim to find out the differences between visual and traditional tactile biofeedback and decide which one is practical and easy to teach the patients in clinical environment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group1		visual feedback	Other: abdominal hallowing maneuver
Group2		traditional feedback	Other: abdominal hallowing maneuver

Interventions

Name	Type	Description	Arm Group Labels	Other Names
abdominal hallowing maneuver	Other	abdominal hallowing maneuver includes tucking navel in and up. To be able to control the effect of breathing it was instructed to start the maneuver at the end of the expiration. During the maneuver it was instructed to focus on increasing the thickness of TrA without increasing the thickness of IO and EO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
thickness change in TrA muscle	thickness change in TrA muscle	1 month

Secondary Outcomes

Measure	Description	Time Frame
thickness change in EO muscle	thickness change in EO muscle	1 month
thickness change in IO muscle	thickness change in IO muscle	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy volunteers between ages of 18-25

Exclusion Criteria:

Volunteers excluded if they had (1) history of LBP, (2) spinal or abdominal surgeries, (3) neuromusculer or romatologic diseases. Each volunteer gave their informed consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

healthy volunteers between ages of 18-25 with no spinal problems.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Esra Dülger	Contact	+905395821958		esradulger@hacettepe.edu.tr
Esra Dülger	Contact	05395821958		esradulger@hacettepe.edu.tr

Overall Officials

Name	Affiliation	Role
Sevil Bilgin	Hacettepe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University	Recruiting	Ankara	Çankaya	06530	Turkey (Türkiye)

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
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided