Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical in Scoliosis

Scoliosis Clinical Trial

Official title:

The Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical Parameters in Scoliotic Adolescents. A Cross Sectional Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06276972
• Other study ID #: P.T.REC/012/005000
• Status: Active, not recruiting
• Start date: March 12, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: February 2024
• Source: Delta University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

BACKGROUND:

Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. Numerous studies deal with the aetiology of the disease, X-ray morphology and classification of curvatures and how the disorder disrupts the spinal biomechanical balance, however the disorder is a complex three-dimensional deformity that affects the body as a whole, and these effects must not be overlooked. No cross-section studies were found assessing the connection between sagittal or coronal balance and the biomechanical parameters of the lower extremity.

HYPOTHESES:

Null hypothesis There are no statistically significant relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents.

RESEARCH QUESTION:

What are the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents?

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 89
• Est. completion date: March 15, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Scoliosis

Intervention

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

Locations

Country	Name	City	State
Egypt	Delta university for science and technology	Gamasa	Dakahleya

Sponsors (2)

Lead Sponsor	Collaborator
Delta University for Science and Technology	Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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