NCT06276972

Brief Summary

To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 11, 2024

Last Update Submit

February 17, 2024

Conditions

Keywords

scoliosisspine alignmentlower limbbiomechanics

Outcome Measures

Primary Outcomes (6)

  • Cobb's angle

    Cobb's angle for dorso-lumbar scoliosis. The angle of the curve apex from D10 to L4 will be assessed by computed radiograph (X-ray computed scanogram)

    at the enrollment

  • Coronal balance

    Coronal balance estimated by the distance between plumb line and central sacral line from Anetroposterior x-ray view assessed by computed radiograph (X-ray computed scanogram )

    at the enrollment

  • length of the the tibia and femur

    The length (in centimeter) of the Tibia and femur will be assessed by computed radiograph (X-ray computed scan-gram)

    at the enrollment

  • tibiofemoral angle

    The tibiofemoral angle (TFA), or knee angle, is defined as the angle between the anatomical axis of femur with the anatomical axis of tibia. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)

    at the enrollment

  • knee joint line convergence angle

    The knee joint-line convergence angle (KJLCA) h is the angle made by a tangential line between the femoral condyles and the tibial plateau. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)

    at the enrollment

  • lower limb mechanical axis; and mechanical axis deviation

    The mechanical axis of the lower limb, also called the Mikulicz line, is drawn by connecting a point in the center of the femoral head to a point in the center of the ankle. The value of the deviation is measured in millimeters and is named mechanical axis deviation (MAD). It will be assessed by computed radiograph (X-ray computed scan-gram).

    at the enrollment

Study Arms (1)

Scoliosis

scoliotic adolescents ranged in age from 10- 18 years will be enrolled

Other: no intervention

Interventions

there's no intervention. it's a cross sectional study correlation study

Scoliosis

Eligibility Criteria

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

adolescents with idiopathic scoliotic curvature of structural origin and in which any secondary causes could be excluded

You may qualify if:

  • Adolescents with age 10-18 years
  • complaining of dorsolumbar scoliosis
  • curves (apex lies between D10 and L4)
  • curve magnitudes greater than 15 degrees and less than 90
  • using or not using brace
  • all maturity levels (Risser = 0-5)

You may not qualify if:

  • Other types of scoliosis ; congenital or neuromuscular
  • Current physical therapy or medical treatment for scoliosis,
  • Contracture or surgery affecting the lumbar spine or lower limbs
  • Pathologies such as inflammatory diseases
  • congenital anomalies
  • Neurological disorders like cerebral palsy or ataxia
  • dislocations
  • visual or auditory problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta university for science and technology

Gamasa, Dakahlia Governorate, 7731168, Egypt

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthopedic Physical Tehrapy

Study Record Dates

First Submitted

February 11, 2024

First Posted

February 26, 2024

Study Start

March 12, 2023

Primary Completion

March 1, 2024

Study Completion

March 15, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

personal preference

Locations