NCT04567914

Brief Summary

We aimed in this study:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

September 24, 2020

Last Update Submit

January 20, 2024

Conditions

Keywords

Abdominal muscleCobb angleImbalanceSpirometryUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Abdominal Muscle Thickness Symmetry

    bilateral ultrasonographic millimetric measurement

    during evaluation, an average of 45 minutes

Secondary Outcomes (2)

  • Spirometry

    during evaluation, an average of 30 minutes

  • Cobb angle

    during evaluation, an average of 30 minutes

Study Arms (2)

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

Diagnostic Test: Bilaterally abdominal muscle thickness with ultrasonography

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.

Diagnostic Test: Bilaterally abdominal muscle thickness with ultrasonography

Interventions

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

Also known as: Spirometry
Adolescent healthy individualsAdolescent idiopathic scoliosis

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

10-18 years old patient with AIS diagnosis 10-18 years old healthy adolescent volunteer

You may qualify if:

  • Cobb angle over 10 degrees in radiological evaluation
  • Between the ages of 10-18 and diagnosed with AIS by a specialist physiatrist

You may not qualify if:

  • 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:
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 17877281BACKGROUND
  • 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.

    PMID: 16140807BACKGROUND
  • 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.

MeSH Terms

Interventions

UltrasonographySpirometry

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory System

Study Officials

  • Muhsin DORAN, MD

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Kadriye Öneş, Assoc Prof

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 29, 2020

Study Start

April 15, 2019

Primary Completion

December 16, 2019

Study Completion

April 1, 2021

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations