- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04567914
Ultrasonographic Evaluation of Abdominal Muscle Thickness Symmetry and Correlation With Pulmonary Function
January 20, 2024 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Ultrasonographic Evaluation of Abdominal Muscle Thickness Symmetry and Correlation With Pulmonary Function Test in Adolescent Idiopathic Scoliosis
We aimed in this study:
- To compare the ultrasonographic measurements of the abdominal muscles thickness symmetry in patients with adolescent idiopathic scoliosis (AIS) and adolescent healthy individuals
- To investigate the effect of measured thickness and symmetry on pulmonary function test.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This cross-sectional,case-control clinical study included 40 patients diagnosed with AIS and 40 age and gender -matched healthy individuals.
AIS group was evaluated for localization of curvature and degree of curvature.
Ultrasonographic measurements and were performed of bilaterally abdominal muscle thickness in both groups.
Spirometry evaluation was performed in both groups.
Intragroup and intergroup data were compared.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34192
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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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
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
10-18 years old patient with AIS diagnosis 10-18 years old healthy adolescent volunteer
Description
Inclusion Criteria:
- Cobb angle over 10 degrees in radiological evaluation
- Between the ages of 10-18 and diagnosed with AIS by a specialist physiatrist
Exclusion Criteria:
- History of previous spinal surgery
- Patients using brace
- Those with any diagnosis of scoliosis other than AIS
- Those with a history of neuromuscular disease
- Previous spinal surgery
- Patients with neurological deficits on examination
- Patients with acute or chronic lung pathology
- Patients with abdominal surgery or injury
- Double curve or multiple curve
- Patients with concomitant chronic diseases
- The child's legal guardian does not allow it to take the tests
The control group:
- 10-18 volunteer adolescents without any health problems,
- In clinical evaluation: Healthy adolescents (without any asymmetric findings on three-way inspection, Adam's forward bend test and scoliometer) were included.
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 |
---|---|
Adolescent idiopathic scoliosis
Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness of AIS patients diagnosed by a specialist.
Spirometry evaluation was performed by the investigator
|
AIS group was evaluated for localization of curvature and degree of curvature.
Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness in the supine and standing positions in both groups.
Spirometry evaluation was performed in both groups
Other Names:
|
Adolescent healthy individuals
Healthy adolescents aged 10-18 were selected.
Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness.
Spirometry evaluation was performed by the investigator.
|
AIS group was evaluated for localization of curvature and degree of curvature.
Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness in the supine and standing positions in both groups.
Spirometry evaluation was performed in both groups
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal Muscle Thickness Symmetry
Time Frame: during evaluation, an average of 45 minutes
|
bilateral ultrasonographic millimetric measurement
|
during evaluation, an average of 45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spirometry
Time Frame: during evaluation, an average of 30 minutes
|
Forced expiratory volume 1 (FEV1), Forced vital capacity (FVC), FEV1/FVC, Peak expiratory flow (PEF)
|
during evaluation, an average of 30 minutes
|
Cobb angle
Time Frame: during evaluation, an average of 30 minutes
|
Measurements were made on orthoroentgenogram, Grouped as Cobb angle <20 and Cobb angle ≥20
|
during evaluation, an average of 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Muhsin DORAN, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Study Chair: Kadriye Öneş, Assoc Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.
- Newton PO, Faro FD, Gollogly S, Betz RR, Lenke LG, Lowe TG. Results of preoperative pulmonary function testing of adolescents with idiopathic scoliosis. A study of six hundred and thirty-one patients. J Bone Joint Surg Am. 2005 Sep;87(9):1937-46. doi: 10.2106/JBJS.D.02209.
- Linek P. Body Mass Normalization for Lateral Abdominal Muscle Thickness Measurements in Adolescent Athletes. J Ultrasound Med. 2017 Sep;36(9):1851-1857. doi: 10.1002/jum.14218. Epub 2017 May 15.
- Yang HS, Yoo JW, Lee BA, Choi CK, You JH. Inter-tester and intra-tester reliability of ultrasound imaging measurements of abdominal muscles in adolescents with and without idiopathic scoliosis: a case-controlled study. Biomed Mater Eng. 2014;24(1):453-8. doi: 10.3233/BME-130830.
- Dreimann M, Hoffmann M, Kossow K, Hitzl W, Meier O, Koller H. Scoliosis and chest cage deformity measures predicting impairments in pulmonary function: a cross-sectional study of 492 patients with scoliosis to improve the early identification of patients at risk. Spine (Phila Pa 1976). 2014 Nov 15;39(24):2024-33. doi: 10.1097/BRS.0000000000000601.
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 15, 2019
Primary Completion (Actual)
December 16, 2019
Study Completion (Actual)
April 1, 2021
Study Registration Dates
First Submitted
September 24, 2020
First Submitted That Met QC Criteria
September 26, 2020
First Posted (Actual)
September 29, 2020
Study Record Updates
Last Update Posted (Estimated)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 20, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstPMRTRH-SCO1
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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