Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics

NCT06266637 | Active Not Recruiting

• 1 other identifier: P.T.REC/012/004999
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.?

Conditions

Scoliosis Idiopathic

Keywords

scoliosis; exercise; lower limb; biomechanics

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)

  From enrollment to the end of treatment at 6 months

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Study group

EXPERIMENTAL

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

Other: Conventional Physical Therapy Program; Other: Physiotherapeutic Scoliosis-Specific Exercise (Schroth)

Control group

ACTIVE COMPARATOR

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

Other: Conventional Physical Therapy Program

Interventions

Conventional Physical Therapy Program OTHER

Conventional Physical Therapy program: trunk muscles strengthening exercises, trunk muscles endurance exercises, trunk proprioception exercises . postural correction exercises. Core exercise Spinal mobility exercises

Control group; Study group

Physiotherapeutic Scoliosis-Specific Exercise (Schroth) OTHER

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

Study group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Delta University for Science and Technology: lead
• Benha University: collaborator

Study Sites (1)

Delta university for science and technology

Gamasa, Dakahlia Governorate, 7731168, Egypt

Location

MeSH Terms

Conditions

Scoliosis; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Orthopedic Physical Therapy

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 20, 2024
• Study Start: March 12, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 15, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)