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Conservative Management for Adolescent Idiopathic Scoliosis

Primary Purpose

Scoliosis; Adolescence

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Scoliosis-Specific Exercise Program
Soft orthoses with external strapping.
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis; Adolescence focused on measuring Adolescents Idiopathic Scoliosis, Physical Therapy, Orthosis

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

The inclusion criteria will be: 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. The exclusion criteria will be: 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.

Sites / Locations

  • Umm Al Qura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in the scoliotic cobb's angle (°)
X-ray imaging will be measured by a radiologist
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2023
Last Updated
April 5, 2023
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT05819034
Brief Title
Conservative Management for Adolescent Idiopathic Scoliosis
Official Title
Orthotic Management for Controlling Scoliotic Curve Progression in Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Scoliosis is one of the most common spinal deformities occurring in school-going children during the growth spurts of adolescents. It is an abnormal curvature of the spine. Failure of early management of idiopathic scoliosis could lead to multiple problems related to postural malalignment, pulmonary and physical dysfunctions, and surgical interventions. These problems could lead to health-related quality-of-life issues such as psychological and social problems that are represented in social isolation, depression, loss of self-confidence, limited job opportunities, and hospital stays & days off school and university as a result of undergoing corrective surgeries. Treatment methods for adolescent idiopathic Scoliosis (AIS) vary between surgical intervention and conservative treatment, in mild and moderate cases. Conservative treatment includes physical therapy in addition to rigid splints and braces, which may cause pain, tightness, restriction of movement, and a bad psychological status for adolescents which may lead them to the irregular wearing of these splints and braces. A type of soft, lightweight, breathable orthosis which is TheraTogs orthotic undergarment with the strapping system has been fabricated to provide gentle, passive compression to correct spinal deformities. Therefore, the objective of this study is to evaluate the effectiveness of TheraTogs orthotic undergarment with the strapping system on controlling and modulating the degree of scoliosis in Saudi adolescents with idiopathic scoliosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Adolescence
Keywords
Adolescents Idiopathic Scoliosis, Physical Therapy, Orthosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Adolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Scoliosis-Specific Exercise Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Soft orthoses with external strapping.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the scoliotic cobb's angle (°)
Description
X-ray imaging will be measured by a radiologist
Time Frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Title
Changes in the Pelvic Obliquity (mm)
Description
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.
Time Frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Title
Change in the vertebral rotation (Angle)
Description
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.
Time Frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]
Title
Change in the Coronal imbalance (mm)
Description
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.
Time Frame
[Data was collected at baseline, and 12 weeks after intervention commencement.]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion criteria will be: 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. The exclusion criteria will be: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehab M Abd El Kafy, PhD
Phone
+966531698541
Email
emkafy@uqu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab M Abd El Kafy, PhD
Organizational Affiliation
Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umm Al Qura University
City
Mecca
ZIP/Postal Code
21955
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehab M Abd El Kafy
Phone
0531698541
Email
emkafy@uqu.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
- The data available is Case-by-case basis at the discretion of the Primary Sponsor
IPD Sharing Time Frame
Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
IPD Sharing Access Criteria
Data can be obtained by Principal Investigator Email Address: emkafy@uqu.edu.sa

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Conservative Management for Adolescent Idiopathic Scoliosis

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