- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04324242
Activating Transversus Abdominis Muscle
June 11, 2020 updated by: Esra Dülger, Hacettepe University
Activating Transversus Abdominis Muscle: A Comparison Of Two Different Feedback Methods
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esra Dülger
- Phone Number: +905395821958
- Email: esradulger@hacettepe.edu.tr
Study Contact Backup
- Name: Esra Dülger
- Phone Number: 05395821958
- Email: esradulger@hacettepe.edu.tr
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06530
- Recruiting
- Hacettepe University
-
Contact:
- Esra Dülger
- Phone Number: 05395821958
- Email: esradulger@hacettepe.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
healthy volunteers between ages of 18-25 with no spinal problems.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group1
visual feedback
|
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
|
Group2
traditional feedback
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
thickness change in TrA muscle
Time Frame: 1 month
|
thickness change in TrA muscle
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
thickness change in EO muscle
Time Frame: 1 month
|
thickness change in EO muscle
|
1 month
|
thickness change in IO muscle
Time Frame: 1 month
|
thickness change in IO muscle
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sevil Bilgin, Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2020
Primary Completion (Actual)
April 30, 2020
Study Completion (Anticipated)
September 15, 2020
Study Registration Dates
First Submitted
March 24, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (Actual)
March 27, 2020
Study Record Updates
Last Update Posted (Actual)
June 12, 2020
Last Update Submitted That Met QC Criteria
June 11, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 16/808
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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