NCT06629948

Brief Summary

Purpose of This study to detect if there is correlation between the Cobb's angle and the forward head posture in patients with Adolescent Idiopathic Scoliosis. And if there is correlation between the Cobb's angle and the cervical sagittal curve angle in AIS. And also if there is correlation between the Cobb's angle and deep flexors muscles endurance in AIS

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

October 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 4, 2024

Last Update Submit

October 4, 2024

Conditions

Keywords

Forward headscoliosiscraniovertebral angle

Outcome Measures

Primary Outcomes (4)

  • 1- Measurement of Craniovertebral angle CVA

    We will measure The Craniovertebral angle by the photogrammetric method

    within 3 months from enrollment

  • Measurement of Cobb's angle

    Measurement of Cobb's angle from whole spine xray

    within 3 months from enrollment

  • Measurement of sagittal cervical curve angle

    Measurement of cervical spines sagittal curve from lateral view X-ray

    within 3 months from enrollment

  • 4- Measurement of deep flexors muscle endurance.

    Activation and performance scores will be recorded.

    within 3 months from enrollment

Interventions

x rayDEVICE

whole spine x ray posterioanterior and lateral views

measure of deep neck flexors muscles endurance

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Thirty four Male and female subjects with adolescent idiopathic scoliosis participating in this study will be assigned homogenously some of them with Cobb's angle below 45 degrees and others above 45 degrees (n=34) and they will sign a consent form.

You may qualify if:

  • Patients with AIS. 2- Patient with forward head posture CVA less than 48 degress. (Fard et al .,2021) 3- Patients aged between 10 and 18 years, (Upasani et al., 2007). 4- Patients who underwent Posterioanterior (PA) and lateral X-ray radiography, and Cobb angle \>10°.(Nasser et al.,2023) 5- Patients with Lenke types (1 to 6). 6- No previous spine surgery ((Wang, et al., 2017).

You may not qualify if:

  • Patients with congenital scoliosis (including hemivertebrae, butterfly vertebrae, and failure of segmentation), (Shu-Man Han et al., 2022 and Nasser et al., 2023).
  • Other developmental thoracic deformity (funnel chest etc.). 3- Scoliosis with definitive reasons (secondary to neurofibromatosis, Marfan syndrome, and syringomyelia).
  • Patients with neurologic deficit or spondylolisthesis (Upasani et al., 2007).
  • History of spinal trauma and infection, and metabolic bone disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (4)

  • Yaman O, Dalbayrak S. Idiopathic scoliosis. Turk Neurosurg. 2014;24(5):646-57. doi: 10.5137/1019-5149.JTN.8838-13.0.

    PMID: 25269032BACKGROUND
  • Latalski M, Danielewicz-Bromberek A, Fatyga M, Latalska M, Krober M, Zwolak P. Current insights into the aetiology of adolescent idiopathic scoliosis. Arch Orthop Trauma Surg. 2017 Oct;137(10):1327-1333. doi: 10.1007/s00402-017-2756-1. Epub 2017 Jul 14.

    PMID: 28710669BACKGROUND
  • Yip CH, Chiu TT, Poon AT. The relationship between head posture and severity and disability of patients with neck pain. Man Ther. 2008 May;13(2):148-54. doi: 10.1016/j.math.2006.11.002. Epub 2007 Mar 23.

    PMID: 17368075BACKGROUND
  • Wang L, Liu X. Cervical sagittal alignment in adolescent idiopathic scoliosis patients (Lenke type 1-6). J Orthop Sci. 2017 Mar;22(2):254-259. doi: 10.1016/j.jos.2016.12.006. Epub 2016 Dec 23.

    PMID: 28025024BACKGROUND

Related Links

MeSH Terms

Conditions

Scoliosis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Enas Fawzy Youssef, Professor

    Professor and chairperson of Department of Orthopaedic Physical Therapy for Musculoskeletal Disorders and its Surgery Faculty of Physical Therapy Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina Ezzat Aziz, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

October 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations