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CompletedNCT05819034Updated Nov 3, 2026

Conservative Management for Adolescent Idiopathic Scoliosis

An interventional study of Scoliosis-Specific Exercise Program and Soft orthoses with external strapping. in Scoliosis; Adolescence, sponsored by Umm Al-Qura University. Completed at 1 site in Saudi Arabia. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Umm Al-Qura University · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Now CompletedStudy completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Scoliosis; Adolescence

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Keywords

  • Adolescents Idiopathic Scoliosis
  • Physical Therapy
  • Orthosis
03

In context

Scoliosis

660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.

This study's enrollment of 60 is above the median of 45 across 386 interventional studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Umm Al-Qura University is the lead sponsor of 47 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Control Group

    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
    Experimental Group

    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

  • OtherScoliosis-Specific Exercise Program

    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.

  • OtherSoft orthoses with external strapping.

    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.

06

What researchers measure

Primary outcomes

  1. Change in the scoliotic cobb's angle (°)

    X-ray imaging will be measured by a radiologist

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

07

Study locations

1 site
  • Umm Al Qura University
    Mecca, Mecca Region 21955, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: Yes — - The data available is Case-by-case basis at the discretion of the Primary Sponsor

Supporting information: Statistical analysis plan

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

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2024 to primary completion in Dec 2025, 22 months.

Of 223 non-industry interventional studies with no phase under Scoliosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 58. This study's 22 months is close to that.

Counting every sponsor, half of 233 studies reached it within 22 months; a quarter within 8 and three quarters within 60.

Completion moved once since we started tracking on Sep 25, 2026: Dec 2025 → May 2026, on Nov 3, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2023
First posted
Apr 19, 2023
StartActual
Feb 1, 2024
Primary completionActual
Dec 20, 2025
CompletionActual
May 20, 2026was Dec 2025
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 3, 2026
Study completion
Dec 20, 2025→May 20, 2026 (actual)
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Recruiting→Completed
    Study completion Dec 20, 2025→May 20, 2026 (now actual)
    + 4 other changes: verification date, oversight details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05819034
Lead sponsor
Umm Al-Qura University
Responsible party
Ehab Mohamed Abd El Kafy (Professor of Physical Therapy, Umm Al-Qura University) — Principal investigator
First posted
Apr 19, 2023
Start date
Feb 1, 2024
Primary completion
Dec 20, 2025
Completion
May 20, 2026
Last update
Nov 3, 2026

Study contacts

Ehab M Abd El Kafy, PhD
principal investigator · Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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