Adolescent Idiopathic ScoliosisNCT07250295
The Effect of Exercise on Paravertebral Muscle Thickness and Quality of Life in Adolescent Idiopathic Scoliosis
A study testing Exercise and Exercise for Lower Extremities in people with Adolescent Idiopathic Scoliosis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study population comprised patients with AIS who had applied to the outpatient clinic between January and June 2022. The patients were divided into two groups. Treatment group(TG) was instructed in specific scoliosis exercises, while the Control group(CG) was given exercises for the lower extremities. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Exercise and Exercise for Lower Extremities
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 15 Aug 2022
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who had been diagnosed with AIS by means of radiographic and clinical examination of the spine were included in the study.
Who cannot join
- Cases with a history of surgery to the paravertebral region
- Metabolic bone disease
- Neuromuscular disease
- chromosomal anomaly
- Serious autoimmune and endocrine disease
- Congenital scoliosis
- Skeletal dysplasia and serious cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
The study population comprised patients with AIS who had applied to the outpatient clinic between January and June 2022. The patients were divided into two groups. Treatment group(TG) was instructed in specific scoliosis exercises, while the Control group(CG) was given exercises for the lower extremities. Each patient was included in a 12- week exercise program accompanied by a physiotherapist. The patients' quality of life, and paravertebral muscles were evaluated ultrasonographically before and after treatment.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Exercise, Exercise for Lower Extremities
- Keywords
- Exercise, Muscles, Scoliosis, Ultrasound
- Medical subject headings
- Motor Activity, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Patients were expected to attend treatment under the supervision of a physiotherapist. If they missed a day, they were contacted by phone and advised to do their exercises at home. The number of days they missed did not exceed five. Each set included a 30-second rest period to prevent fatigue. A five-minute warm-up and cool-down period was allotted before and after the exercise session. The exercise program was implemented by a physiotherapist with three years of experience in scoliosis management. Before initiating the intervention, the physiotherapist underwent a structured training session, including practical demonstrations, supervised practice, and detailed exercise protocols.
Exercise for Lower ExtremitiesOther
The control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | The treatment group (TG) was given exercises for the thoracic and lumbar regions for scoliosis. Receives: Other: Exercise |
| Control Group | Placebo comparator | The control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises. Receives: Other: Exercise for Lower Extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paravertebral Muscle Thickness in Ultrasonographic Measurements
A standard imaging protocol was employed for the transverse imaging of the thoracic and lumbar multifidus muscles. Pre- and post-exercise measurements were performed by the same physician who was blinded to the exercise program the patient received. This evaluator was a PMR physician with 3 years of experience in the field of ultrasound. For each ultrasound image, the examiner positioned the probe over the spinous process and then moved it laterally and proceeded to image the multifidus and deep thoracic paravertebral muscles on both the convex and concave sides of the apex with the patient positioned prone. Two images were obtained for each segment on each side. The mean of the two trials was employed for the purpose of data analysis.
Measured: 12 weeks
The Turkish version of the Spinal Appearance Questionnaire (Tr-SGA)
The questionnaire comprises two distinct sections: one pertaining to appearance and the other to expectations. Each section contains a series of questions presented on a 5-point Likert scale.
Measured: 12 weeks
Secondary outcomes (1)
The Short Form-36 Health Status Questionnaire (SF-36)
The Short Form-36 Health Status Questionnaire (SF-36) was employed for the purpose of assessing quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roza Jizel Dagdelen MD, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250295
- Sponsor's protocol ID
- 28.12.2021 / 3388
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 9 Jan 2026
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Paravertebral Muscle Thickness and Quality of Life in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07250295
- Acronym / sponsor ID
- 28.12.2021 / 3388
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Exercise, Muscles, Scoliosis, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 26 Nov 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.
The study population comprised patients with AIS who had applied to the outpatient clinic between January and June 2022. The patients were divided into two groups. Treatment group(TG) was instructed in specific scoliosis exercises, while the Control group(CG) was given exercises for the lower extremities. Each patient was included in a 12- week exercise program accompanied by a physiotherapist. The patients' quality of life, and paravertebral muscles were evaluated ultrasonographically before and after treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Other: ExerciseThe treatment group (TG) was given exercises for the thoracic and lumbar regions for scoliosis. |
| Control Group | Placebo comparator | Other: Exercise for Lower ExtremitiesThe control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who had been diagnosed with AIS by means of radiographic and clinical examination of the spine were included in the study.
Key exclusion criteria (7 listed)
- Cases with a history of surgery to the paravertebral region
- Metabolic bone disease
- Neuromuscular disease
- chromosomal anomaly
- Serious autoimmune and endocrine disease
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 |
|---|---|---|
| ExercisePatients were expected to attend treatment under the supervision of a physiotherapist. If they missed a day, they were contacted by phone and advised to do their exercises at home. The number of days they missed did not exceed five. Each set included a 30-second rest period to prevent fatigue. A five-minute warm-up and cool-down period was allotted before and after the exercise session. The exercise program was implemented by a physiotherapist with three years of experience in scoliosis management. Before initiating the intervention, the physiotherapist underwent a structured training session, including practical demonstrations, supervised practice, and detailed exercise protocols. | Other | Treatment Group |
| Exercise for Lower ExtremitiesThe control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises. | Other | Control Group |
Primary outcome
Paravertebral Muscle Thickness in Ultrasonographic Measurements
Time frame: 12 weeks
A standard imaging protocol was employed for the transverse imaging of the thoracic and lumbar multifidus muscles. Pre- and post-exercise measurements were performed by the same physician who was blinded to the exercise program the patient received. This evaluator was a PMR physician with 3 years of experience in the field of ultrasound. For each ultrasound image, the examiner positioned the probe over the spinous process and then moved it laterally and proceeded to image the multifidus and deep thoracic paravertebral muscles on both the convex and concave sides of the apex with the patient positioned prone. Two images were obtained for each segment on each side. The mean of the two trials was employed for the purpose of data analysis.
The Turkish version of the Spinal Appearance Questionnaire (Tr-SGA)
Time frame: 12 weeks
The questionnaire comprises two distinct sections: one pertaining to appearance and the other to expectations. Each section contains a series of questions presented on a 5-point Likert scale.
1 secondary outcome
The Short Form-36 Health Status Questionnaire (SF-36)
Time frame: 12 weeks
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 9 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Exercise for Lower Extremities in people with Adolescent Idiopathic Scoliosis, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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 9 Jan 2026. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Paravertebral Muscle Thickness in Ultrasonographic Measurements (time frame: 12 weeks). 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 9 Jan 2026.