Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics

Scoliosis Idiopathic Clinical Trial

Official title:

Effect of Physiotherapeutic Scoliosis-Specific Exercise on Lower Limb Biomechanics in Adolescents With Idiopathic Scoliosis: A Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06266637
• Other study ID #: P.T.REC/012/004999
• Status: Active, not recruiting
• Phase: N/A
• 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: Interventional

Clinical Trial Summary

PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial

BACKGROUND:

Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.

HYPOTHESES:

Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.

RESEARCH QUESTION:

What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.?

Description:

procedures: A randomized controlled clinical trial will be conducted

Assessment:

x-ray computed scanogram radiography of the whole spine and both lower limbs in standing will be used.

The following measurements will be taken pre and post the treatment program:

For the lumbar spine coronal alignment:

1. Cobb's angle for dorso-lumbar scoliosis (curve apex from D10- L4) will be measured.

2. Coronal balance estimated by the distance between plumb line and central sacral line from anterioposterior x-ray view

For both lower limbs:

1. the length will be measured for the limb, the tibia and the femur

2. tibiofemoral angle

3. joint line convergence angle

4. mechanical axis

5. mechanical axis deviation

Treatment:

Patients will be randomly assigned into two groups to receive the prescribed treatment program for 6 months., 1 session per week in addition to a home program of daily exercise .

The control group will receive the standard care composed of trunk muscles strengthening exercises, trunk proprioception exercises .

The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise

Data will be analyzed using 2 way MANOVA.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: March 15, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• 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
• Scoliosis Idiopathic

Intervention

Other:
• Conventional Physical Therapy Program
Conventional Physical Therapy program: trunk muscles strengthening exercises, trunk muscles endurance exercises, trunk proprioception exercises . postural correction exercises. Core exercise Spinal mobility exercises
• Physiotherapeutic Scoliosis-Specific Exercise (Schroth)
It uses exercises customized for each patient to return the curved spine to a more natural position. The spine is addressed in all three anatomical planes - sagittal, frontal and transverse. The purpose of the method is to create spinal balance and stability by improving body mechanics and spinal stabilization to prevent further curve progression

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)	From enrollment to the end of treatment at 6 months
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 )	From enrollment to the end of treatment at 6 months
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)	From enrollment to the end of treatment at 6 months
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)	From enrollment to the end of treatment at 6 months
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)	From enrollment to the end of treatment at 6 months
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).	From enrollment to the end of treatment at 6 months