Scoliosis; AdolescenceNCT05819034
Conservative Management for Adolescent Idiopathic Scoliosis
A study testing Scoliosis-Specific Exercise Program and Soft orthoses with external strapping. in people with Scoliosis; Adolescence, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Scoliosis; Adolescence
- What is being tested?
- Scoliosis-Specific Exercise Program and Soft orthoses with external strapping.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2024to 20 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Umm Al Qura University
Mecca, Mecca Region, 21955
Ehab M Abd El Kafy, 0531698541, emkafy@uqu.edu.sa
About this study
Official title: Orthotic Management for Controlling Scoliotic Curve Progression in Adolescent Idiopathic Scoliosis
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.
Read the 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.
- Conditions
- Scoliosis; Adolescence
- Being tested
- Scoliosis-Specific Exercise Program, Soft orthoses with external strapping.
- Keywords
- Adolescents Idiopathic Scoliosis, Physical Therapy, Orthosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoliosis-Specific Exercise ProgramOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Scoliosis-Specific Exercise Program; Other: Soft orthoses with external strapping. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the scoliotic cobb's angle (°)
X-ray imaging will be measured by a radiologist
Measured: [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.
Measured: [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.
Measured: [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.
Measured: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Feb 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Abd El Kafy, Umm Al-Qura University
- Investigators
- Ehab M Abd El Kafy, PhD, Principal investigator, Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819034
- Sponsor's protocol ID
- DSR02
- Status last verified
- Sep 2025
- First submitted
- 5 Apr 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: \- The data available is Case-by-case basis at the discretion of the Primary Sponsor