Idiopathic ScoliosisNCT06803121
The Effect of Core Stability Exercises on Idiopathic Scoliosis in Adolescent Females
A study testing Traditional treatment and Core stability exercises in people with Idiopathic Scoliosis, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate the efficacy of core stability (CS) exercises on curve magnitude, posture, trunk deformity and quality of life in adolescent females with idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 19 years, women only
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Traditional treatment and Core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Their ages will be ranged from 10-19 years.
- All adolescent Females will be diagnosed as idiopathic scoliosis with S shape.
- Cobb angle on anterior-posterior radiograph will be used in the assessment of thoracic and lumbar cure of each patient in this study.
- All adolescent females are not under any other treatment method for idiopathic scoliosis.
- Willingness and ability to comply with the study requirements and give informed consent.
Who cannot join
- Patients with a history of rheumatologic, neuromuscular, cardiovascular, pulmonary, or renal diseases.
- Patients with congenital scoliosis or spinal deformity.
- Patients who had undergone surgical correction of the spine.
- Patients with a tumor.
- Enrollment in any other clinical trial during the time of this trial.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy of core stability (CS) exercises on curve magnitude, posture, trunk deformity and quality of life in adolescent females with idiopathic scoliosis.
Read the detailed description
Scoliosis is a disease in which the spine deviates or rotates laterally from its normal vertical line, and it can cause decreased spinal movement, weakening of muscles near the spine, reduced pulmonary function, respiratory dysfunction, chronic pain, and psychological suffering. Scoliosis can be classified as idiopathic, congenital, neurofibromatosis, and neuromuscular. Among these types of scoliosis, approximately 80% of patients with scoliosis have AIS, which typically occurs around 10 years of age when healthy bone maturation occurs during adolescence. IS is diagnosed when there are no known causes besides spinal deformity involving a lateral curvature with a Cobb angle ≥10°.
Therapeutic approaches for IS include surgical and conservative treatments. Exercise therapy for IS is considered important for maintaining spinal function when the Cobb angle is <20°. Moreover, the effects of core stabilization exercise have been demonstrated recently for alleviating chronic lower back pain in patients, improving performance in athletes, and preventing sports injuries in athletes. Based on this information, core stabilization exercise may be used effectively to improve neuromuscular imbalance, which is the cause of IS. However, studies on the therapeutic effects of using core stabilization exercise in patients with AIS are still lacking.
Accordingly, the objective of this study is to evaluate the efficacy of core stability exercises on curve magnitude, posture, trunk deformity, and quality of life in adolescent females with idiopathic scoliosis.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Traditional treatment, Core stability exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional treatmentOther
Traditional exercises for scoliosis include breathing exercises, posture training, spinal flexibility exercises, stretching exercises for the involved muscles (especially for the concave side of the curve), and general strengthening exercises for the main muscle groups of trunk, pelvis, and shoulder girdle muscles (especially for the convex side of the curve).
Core stability exercisesOther
The CS training program includes local muscle stability training (transverses abdominis, multifidus, and diaphragm), global muscle stability training (oblique abdominal muscles, psoas major, quadratus lumborum, and pelvic floor muscles), global muscle mobility training (rectus abdominis, back extensors, and hamstring muscles), and strength training of the core muscles through the thoracolumbar fascia by maintaining the neutral spine position. Diaphragmatic breathing technique will be used during exercises.
| Study group | Role | What they receive |
|---|---|---|
| Traditional treatment | Active comparator | It will be consisted of thirty adolescent females with idiopathic scoliosis and will be treated by traditional treatment (traditional exercises and bracing), two sessions per week for three months (24 sessions). Receives: Other: Traditional treatment |
| Traditional treatment + Core stability exercises | Experimental | It will be consisted of thirty adolescent females with idiopathic scoliosis and will be treated by traditional treatment (traditional exercises and bracing) in addition to core stability exercises, two sessions per week for three months (24 sessions). Receives: Other: Traditional treatment; Other: Core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Cobb angles
Cobb angles on anterior and posterior spine radiographs taken in standing position. The Cobb angle is the angle between two lines, drawn perpendicular to the upper endplate of the uppermost vertebra involved and the lower endplate of the lowest vertebra involved. Once a patient's Cobb angle is determined, the condition can be further classified on its severity scale of mild, moderate, or severe. Cobb angles will be assessed for all adolescent females in both groups A \& B before and after treatment.
Measured: 3 months
Measurement of trunk asymmetry in scoliosis
A scoliometer is an instrument that measures trunk asymmetry in scoliosis, or angle of trunk rotation (ATR). It is a small, non-invasive device (essentially a mini-level) that is placed over the spine while a person is in a forward bending position. The scoliometer reading indicates degree of trunk asymmetry (rotation). Generally, an angle of trunk rotation that is less than 5 degrees is insignificant and may not require follow-up. A measurement of 5 to 9 degrees at least warrants reexamination in six months. A measurement of 10 degrees or greater requires radiologic evaluation for Cobb angle measurement.
Measured: 3 months
Secondary outcomes (2)
Trunk appearance perception scale (TAPS)
TAPS includes 3 sets of figures that depict the trunk from 3 viewpoints: looking toward the back, looking toward the head with the patient bending over (Adam's test), and looking toward the front. This last view has two sets of drawings, one for males and one for females. Each drawing is scored from 1 (greatest deformity) to 5 (smallest deformity) and a mean score is obtained by adding the scores for the 3 drawings and dividing by 3.
Measured: 3 months
The Scoliosis research society-22 questionnaire (SRS-22)
The SRS-22 contains 22 questions covering 5 domains: function/activity, 5 items; pain, 5 items; self-perceived body image, 5 items; mental health, 5 items; and satisfaction with treatment, 2 items. The satisfaction scale was not used in the present study. Each item is scored from 1 (worst) to 5 (best). In the present study, the results are expressed as the mean for each domain (total sum of the domain divided by the number of items answered) and the total score.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Feb 2025
- Primary completion1 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Bahig Shawky Heneen, Cairo University
- Investigators
- Mohamed Ahmed Mohamed Awad, PhD, Study chair, Professor, Cairo universityAfaf Mohamed Mahmoud Botla, PhD, Study director, Assistant Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803121
- Sponsor's protocol ID
- P.T.REC/012/004728
- Status last verified
- May 2025
- First submitted
- 27 Jan 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stability Exercises on Idiopathic Scoliosis in Adolescent Females
- ClinicalTrials.gov ID
- NCT06803121
- Acronym / sponsor ID
- P.T.REC/012/004728
- Conditions
- Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of core stability (CS) exercises on curve magnitude, posture, trunk deformity and quality of life in adolescent females with idiopathic scoliosis.
Detailed description
Scoliosis is a disease in which the spine deviates or rotates laterally from its normal vertical line, and it can cause decreased spinal movement, weakening of muscles near the spine, reduced pulmonary function, respiratory dysfunction, chronic pain, and psychological suffering. Scoliosis can be classified as idiopathic, congenital, neurofibromatosis, and neuromuscular. Among these types of scoliosis, approximately 80% of patients with scoliosis have AIS, which typically occurs around 10 years of age when healthy bone maturation occurs during adolescence. IS is diagnosed when there are no known causes besides spinal deformity involving a lateral curvature with a Cobb angle ≥10°.
Therapeutic approaches for IS include surgical and conservative treatments. Exercise therapy for IS is considered important for maintaining spinal function when the Cobb angle is <20°. Moreover, the effects of core stabilization exercise have been demonstrated recently for alleviating chronic lower back pain in patients, improving performance in athletes, and preventing sports injuries in athletes. Based on this information, core stabilization exercise may be used effectively to improve neuromuscular imbalance, which is the cause of IS. However, studies on the therapeutic effects of using core stabilization exercise in patients with AIS are still lacking.
Accordingly, the objective of this study is to evaluate the efficacy of core stability exercises on curve magnitude, posture, trunk deformity, and quality of life in adolescent females with idiopathic scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional treatment | Active comparator | Other: Traditional treatmentIt will be consisted of thirty adolescent females with idiopathic scoliosis and will be treated by traditional treatment (traditional exercises and bracing), two sessions per week for three months (24 sessions). |
| Traditional treatment + Core stability exercises | Experimental | Other: Traditional treatment, Other: Core stability exercisesIt will be consisted of thirty adolescent females with idiopathic scoliosis and will be treated by traditional treatment (traditional exercises and bracing) in addition to core stability exercises, two sessions per week for three months (24 sessions). |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Their ages will be ranged from 10-19 years.
- All adolescent Females will be diagnosed as idiopathic scoliosis with S shape.
- Cobb angle on anterior-posterior radiograph will be used in the assessment of thoracic and lumbar cure of each patient in this study.
- All adolescent females are not under any other treatment method for idiopathic scoliosis.
- Willingness and ability to comply with the study requirements and give informed consent.
Key exclusion criteria (5 listed)
- Patients with a history of rheumatologic, neuromuscular, cardiovascular, pulmonary, or renal diseases.
- Patients with congenital scoliosis or spinal deformity.
- Patients who had undergone surgical correction of the spine.
- Patients with a tumor.
- Enrollment in any other clinical trial during the time of this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional treatmentTraditional exercises for scoliosis include breathing exercises, posture training, spinal flexibility exercises, stretching exercises for the involved muscles (especially for the concave side of the curve), and general strengthening exercises for the main muscle groups of trunk, pelvis, and shoulder girdle muscles (especially for the convex side of the curve). | Other | Traditional treatment, Traditional treatment + Core stability exercises |
| Core stability exercisesThe CS training program includes local muscle stability training (transverses abdominis, multifidus, and diaphragm), global muscle stability training (oblique abdominal muscles, psoas major, quadratus lumborum, and pelvic floor muscles), global muscle mobility training (rectus abdominis, back extensors, and hamstring muscles), and strength training of the core muscles through the thoracolumbar fascia by maintaining the neutral spine position. Diaphragmatic breathing technique will be used during exercises. | Other | Traditional treatment + Core stability exercises |
Primary outcome
Measurement of Cobb angles
Time frame: 3 months
Cobb angles on anterior and posterior spine radiographs taken in standing position. The Cobb angle is the angle between two lines, drawn perpendicular to the upper endplate of the uppermost vertebra involved and the lower endplate of the lowest vertebra involved. Once a patient's Cobb angle is determined, the condition can be further classified on its severity scale of mild, moderate, or severe. Cobb angles will be assessed for all adolescent females in both groups A \& B before and after treatment.
Measurement of trunk asymmetry in scoliosis
Time frame: 3 months
A scoliometer is an instrument that measures trunk asymmetry in scoliosis, or angle of trunk rotation (ATR). It is a small, non-invasive device (essentially a mini-level) that is placed over the spine while a person is in a forward bending position. The scoliometer reading indicates degree of trunk asymmetry (rotation). Generally, an angle of trunk rotation that is less than 5 degrees is insignificant and may not require follow-up. A measurement of 5 to 9 degrees at least warrants reexamination in six months. A measurement of 10 degrees or greater requires radiologic evaluation for Cobb angle measurement.
2 secondary outcomes
Trunk appearance perception scale (TAPS)
Time frame: 3 months
The Scoliosis research society-22 questionnaire (SRS-22)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Related trials for Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Ahmed Mohamed Awad, PhD study chair
Professor, Cairo university
Afaf Mohamed Mahmoud Botla, PhD study director
Assistant Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional treatment and Core stability exercises in people with Idiopathic Scoliosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Cobb angles (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.