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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04567914
Other study ID # IstPMRTRH-SCO1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2019
Est. completion date April 1, 2021

Study information

Verified date January 2024
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

We aimed in this study: 1. To compare the ultrasonographic measurements of the abdominal muscles thickness symmetry in patients with adolescent idiopathic scoliosis (AIS) and adolescent healthy individuals 2. To investigate the effect of measured thickness and symmetry on pulmonary function test.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 1, 2021
Est. primary completion date December 16, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Bilaterally abdominal muscle thickness with ultrasonography
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

Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Abdominal Muscle Thickness Symmetry bilateral ultrasonographic millimetric measurement during evaluation, an average of 45 minutes
Secondary Spirometry Forced expiratory volume 1 (FEV1), Forced vital capacity (FVC), FEV1/FVC, Peak expiratory flow (PEF) during evaluation, an average of 30 minutes
Secondary Cobb angle Measurements were made on orthoroentgenogram, Grouped as Cobb angle <20 and Cobb angle =20 during evaluation, an average of 30 minutes
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