Conservative Management for Adolescent Idiopathic Scoliosis

NCT05819034 | Recruiting

• 1 other identifier: DSR02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic scoliosis is a living problem that resists correction. The underlying cause of the such disorder is unknown but directed more toward muscular disorders. However recent clinical observation showed a possible neuromuscular compromise early in those patients. The main purpose of this study is to develop a treatment procedure to correct the degree of bony curvature in patients with Idiopathic scoliosis through developing a neuromuscular corrective approach that might be a more effective conservative treatment protocol for such disorder.

Conditions

Scoliosis; Adolescence

Keywords

Adolescents Idiopathic Scoliosis; Physical Therapy; Orthosis

Outcome Measures

Primary Outcomes (4)

• Change in the scoliotic cobb's angle (°)

  X-ray imaging will be measured by a radiologist

  [Data was collected at baseline, and 12 weeks after intervention commencement.]

• Changes in the Pelvic Obliquity (mm)

  The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.

  [Data was collected at baseline, and 12 weeks after intervention commencement.]

• Change in the vertebral rotation (Angle)

  The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.

  [Data was collected at baseline, and 12 weeks after intervention commencement.]

• Change in the Coronal imbalance (mm)

  The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.

  [Data was collected at baseline, and 12 weeks after intervention commencement.]

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Adolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve

Other: Scoliosis-Specific Exercise Program

Experimental Group

EXPERIMENTAL

Adolescents in the experimental group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve in addition to wearing the soft orthoses with external strapping.

Other: Scoliosis-Specific Exercise Program; Other: Soft orthoses with external strapping.

Interventions

Scoliosis-Specific Exercise Program OTHER

Adolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve. This exercise program will include frontal plane active or passive correction exercises for scoliotic posture. The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour.The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour. The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour.

Control Group; Experimental Group

Soft orthoses with external strapping. OTHER

Adolescents in the experimental group will receive a scoliosis-specific exercises program which will be prescribed to control the progression of the scoliotic curve in addition to wearing the soft orthoses with external strapping. The wearing schedule of the soft orthosis with the external strapping for every participant in this group will be 12 hours daily for 12 successive weeks.

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Adolescents of both sexes with an age range between 10-17 years.
• They were diagnosed with Adolescent idiopathic scoliosis by an orthopedic specialist, confirmed through (loaded) X- rays.
• They have mild non-structural scoliosis with Cobb's angle measurement of between 10 and 25 degrees
• They have Single major thoracolumbar curve located between T6-7 to L1-2, apex at T12 or L1.
• They have good health conditions except for scoliosis.
• They can understand and communicate with no mental abnormalities.

You may not qualify if:

• Adolescents with cerebral palsy or other degenerative neurological disorders;
• Participants with nutritional disorders e.g. diabetes or vascular disorders.
• Participants with a scoliotic curve with angle \> 25° will be excluded.
• Participants will be excluded from this study if they have inflexible spinal deformities interfering with spinal mobility,
• Participants who were subjected to any corrective surgery to their spine within the previous two years.
• Participants will be also excluded if their skin were sensitive or inflamed to any materials used.
• Participants who have seizures, perceptual disorders, visual problems, and auditory deficits
• Participants who have leg length discrepancy
• Participants who have scoliosis developed as a consequence of traumatic scoliosis.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al Qura University

Mecca, Mecca Region, 21955, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ehab M Abd El Kafy, PhD

  Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehab M Abd El Kafy, PhD

CONTACT

+966531698541; emkafy@uqu.edu.sa

Study Design

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

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: February 1, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
• Access Criteria: Data can be obtained by Principal Investigator Email Address: emkafy@uqu.edu.sa

Locations

SA (1)