Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics

NCT ID: NCT06266637

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-12
• Study Completion Date: 2024-03-15

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.?

Detailed 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.

Conditions

Scoliosis Idiopathic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Conventional Physical Therapy Program

Intervention Type: OTHER

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)

Intervention Type: 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

Control group

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

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy Program

Intervention Type: OTHER

Conventional Physical Therapy program:

trunk muscles strengthening exercises, trunk muscles endurance exercises, trunk proprioception exercises . postural correction exercises. Core exercise Spinal mobility exercises

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: collaborator

Delta University for Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Omar Mohamed Ali Elabd

Lecturer of Orthopedic Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Delta university for science and technology

Gamasa, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004999

Identifier Type: -

Identifier Source: org_study_id