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Scoliosis Idiopathic AdolescentSPINE-AIS16NCT07736456

Effect of a 16-Week Physiotherapeutic Corrective Exercise Program on Spinal Deformities in Adolescent Idiopathic Scoliosis

A study testing Structured Physiotherapeutic Corrective Exercise Program and Standard Physiotherapy Exercise Program in people with Scoliosis Idiopathic Adolescent, run by Alma Mater Europaea - Slovenia at 1 site in Kosovo.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Brief Summary Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may progress during adolescence and lead to postural asymmetry, spinal rotation, pelvic imbalance, reduced spinal mobility, and decreased quality of life. Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Scoliosis Idiopathic Adolescent
What is being tested?
Structured Physiotherapeutic Corrective Exercise Program and Standard Physiotherapy Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteKosovo
Study dates
12 Jan 2026to 12 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Adolescents aged 10 to 18 years.
  • Diagnosis of mild to moderate adolescent idiopathic scoliosis (AIS) with a Cobb angle between 10° and 40°.
  • Referred for physiotherapy treatment at the Physical Medicine and Rehabilitation Clinic.
  • Ability to participate in a 16-week exercise program.
  • Written informed consent from a parent or legal guardian and assent from the participant.
  • Agreement not to receive additional scoliosis-specific treatment during the study period.

Who cannot join

  • Non-idiopathic scoliosis (congenital, neuromuscular, or syndromic scoliosis).
  • Cervicothoracic scoliosis.
  • Previous scoliosis surgery.
  • Brace treatment during the study period.
  • Previous scoliosis-specific physiotherapy during the study period.
  • Neurological disorders affecting posture or gait.
Show all 11Show fewer
  • Congenital or structural spinal abnormalities.
  • Lower extremity neuromuscular disorders.
  • Leg length discrepancy.
  • Cardiovascular or respiratory conditions contraindicating exercise.
  • Inability to participate in the intervention or complete outcome assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kosovo1 site
  • Physical Medicine and Rehabilitation Clinic, University Clinical Center of Kosovo (UCCK)

    Pristina, Kosovo, 10000

Other trials in Kosovo

About this study

Official title: The Effect of a 16-Week Structured Physiotherapeutic Corrective Exercise Program on Lateral Spinal Deviation, Vertebral Rotation, and Pelvic Position in Mild and Moderate Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may progress during adolescence and lead to postural asymmetry, spinal rotation, pelvic imbalance, reduced spinal mobility, and decreased quality of life.

Read more

This randomized controlled trial aims to evaluate the effectiveness of a 16-week structured physiotherapeutic corrective exercise program compared with standard physiotherapy care in adolescents with mild to moderate AIS (Cobb angle 10°-40°).

Participants aged 10-18 years will be randomly assigned to either an experimental group or a control group using stratified block randomization based on age and baseline Cobb angle. The study will be conducted under the responsibility of the University of Prishtina- Faculty of Medicine and the University Clinical Center of Kosovo, with academic collaboration from Alma Mater Europaea.

The experimental group will receive a structured physiotherapeutic corrective exercise program including core stabilization, stretching, spinal self-correction, and pelvic correction exercises. The control group will receive standard physiotherapy exercises used in routine clinical practice.

Both groups will undergo supervised physiotherapy sessions three times per week for 16 weeks, with additional prescribed home exercises.

Primary outcomes include individual spinal alignment parameters assessed using the DIERS Formetric 3D/4D system, including lateral deviation angle and vertebral rotation. Secondary outcomes include additional postural alignment parameters, spinal mobility measured using an inclinometer, and health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.

Assessments will be performed at baseline, 8 weeks, and 16 weeks. Each outcome parameter will be analyzed separately to evaluate changes over time and differences between groups.

The study will provide evidence on whether a structured corrective physiotherapy program offers superior outcomes compared with standard physiotherapy care in adolescents with AIS.

Read the detailed description

Detailed Description

This randomized controlled trial evaluates the effectiveness of a structured physiotherapeutic corrective exercise program in adolescents with mild to moderate idiopathic scoliosis (Cobb angle 10°-40°), compared with standard physiotherapy care.

Adolescent idiopathic scoliosis is a structural spinal deformity characterized by lateral curvature, vertebral rotation, and postural imbalance. It may also be associated with pelvic asymmetry, altered sagittal spinal alignment, reduced spinal mobility, and impaired health-related quality of life.

Despite evidence supporting physiotherapeutic scoliosis-specific exercises, limited research has investigated comprehensive exercise programs addressing spinal alignment, postural control, and pelvic-related impairments simultaneously using advanced three-dimensional postural assessment systems.

Participants aged 10-18 years will be recruited from the Physical Medicine and Rehabilitation Clinic at the University Clinical Center of Kosovo and the University of Prishtina - Faculty of Medicine. The study is conducted under ethical approval from relevant institutional ethics committees. Alma Mater Europaea serves as an academic collaborating institution.

Participants will be randomly allocated to an experimental or control group using stratified block randomization based on age and baseline Cobb angle. Outcome assessors and statisticians will be blinded to group allocation.

The experimental group will follow a 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spinal self-correction, and pelvic correction exercises. The control group will receive standard physiotherapy exercises commonly used in clinical practice for adolescent idiopathic scoliosis.

Both groups will receive supervised physiotherapy sessions three times per week for 16 weeks, each lasting approximately 45 minutes, and will perform additional home-based exercises two days per week.

Primary outcome measures will include individual spinal alignment parameters assessed using the DIERS Formetric 3D/4D Spine \& Posture Analysis System, including change in lateral deviation angle and change in vertebral rotation. Each parameter will be analyzed as a separate outcome measure.

Secondary outcome measures will include individual postural and functional parameters assessed separately, including trunk imbalance, trunk inclination, pelvic obliquity, pelvic torsion, pelvic rotation, kyphotic angle, lordotic angle, spinal mobility measured using an inclinometer, and health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.

Measurements will be performed at baseline, 8 weeks, and 16 weeks. Statistical analysis will compare within-group and between-group changes over time using appropriate parametric and non-parametric tests, with statistical significance set at p < 0.05.

Additionally, agreement between angle of trunk rotation measured by scoliometer and vertebral rotation measured by the DIERS Formetric 3D/4D system will be evaluated as an exploratory analysis.

Being tested
Structured Physiotherapeutic Corrective Exercise Program, Standard Physiotherapy Exercise Program
Keywords
physiotherapy, spine autocorection exercises, core stabilization, spinal posture, pelvic alignment, DIERS Formetric 3D/4D, adolescent idiopathic scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Physiotherapeutic Corrective Exercise ProgramBehavioural

    A 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spine autocorrection, and pelvic stabilization and correction exercises. Participants will attend supervised sessions three times per week and perform home exercises two additional days per week.

  • Standard Physiotherapy Exercise ProgramBehavioural

    The Standard Physiotherapy Exercise Program will last 16 weeks and consists of conventional therapeutic exercises aimed at improving spinal strength, flexibility, posture, and coordination in adolescents with idiopathic scoliosis.

Study groups in NCT07736456
Study groupRoleWhat they receive
Structured Physiotherapeutic Corrective Exercise ProgramExperimentalParticipants will receive a 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spine autocorrection, and pelvic stabilization and correction exercises. Supervised sessions will be conducted three times per week, with additional home exercises performed two days per week.
Receives: Behavioral: Structured Physiotherapeutic Corrective Exercise Program
Standard Physiotherapy Exercise ProgramActive comparatorParticipants will receive a standard physiotherapy exercise program consisting of conventional strengthening, stretching, postural correction, and flexibility exercises. Supervised sessions will be conducted three times per week, with additional home exercises performed two days per week.
Receives: Behavioral: Standard Physiotherapy Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in lateral spinal deviation

    Change from baseline to Week 16 in lateral spinal deviation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).

    Measured: Week 16

  2. Change in vertebral rotation

    Change from baseline to Week 16 in vertebral rotation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).

    Measured: Week 16

Secondary outcomes (9)
  1. Change in trunk imbalance

    Change from baseline to Week 16 in trunk imbalance measured by the DIERS Formetric 3D/4D system. The outcome will be reported in millimeters (mm).

    Measured: Week 16

  2. Change in trunk inclination

    Change from baseline to Week 16 in trunk inclination measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).

    Measured: Week 16

  3. Change in pelvic obliquity

    Change from baseline to Week 16 in pelvic obliquity measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).

    Measured: Week 16

  4. Change in pelvic torsion

    Change from baseline to Week 16 in pelvic torsion measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).

    Measured: Week 16

  5. Change in pelvic rotation

    Change from baseline to Week 16 in pelvic rotation measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).

    Measured: Week 16

  6. Change in kyphotic angle

    Change from baseline to Week 16 in thoracic kyphotic angle measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).

    Measured: Week 16

  7. Change in lordotic angle

    Change from baseline to Week 16 in lumbar lordotic angle measured by the DIERS Formetric 3D/4D system. The outcome will be reported in degrees (°).

    Measured: Week 16

  8. Change in spinal mobility

    Change from baseline to Week 16 in spinal mobility measured using an inclinometer. The outcome will be reported in degrees (°).

    Measured: Week 16

  9. Change in health-related quality of life

    Change from baseline to Week 16 in health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire. Scores range from 22 to 110, with higher scores indicating better health-related quality of life.

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start12 Jan 2026
  3. Primary completion12 May 2026
  4. Study completion12 Aug 2026 (estimated)

Resources

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
Model description
Participants will be randomly assigned to either an experimental group receiving a structured physiotherapeutic corrective exercise program or a control group receiving standard physiotherapy care.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07736456
Sponsor's protocol ID
UP-PT-2026-001
Other IDs
UP-PT-2026-001
Acronym
SPINE-AIS16
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to participant confidentiality and privacy considerations. The dataset contains sensitive clinical and anthropometric information of adolescent participants, and sharing of IPD is not planned to ensure compliance with institutional ethics approvals and data protection regulations. Aggregate results will be reported in publications and presentations.

Publications

  • Akcay B, Colak TK, Apti A, Colak I. The Immediate Effect of Hanging Exercise and Muscle Cylinder Exercise on the Angle of Trunk Rotation in Adolescent Idiopathic Scoliosis. Healthcare (Basel). 2024 Jan 24;12(3):305. doi: 10.3390/healthcare12030305.

    PubMed 38338189
  • Schreiber S, Parent EC, Moez EK, et al. Schroth physiotherapeutic scoliosis-specific exercises for adolescent idiopathic scoliosis. PLoS ONE. 2016;11(6):e0158739.

Questions about this trial

What is this clinical trial studying?

A study testing Structured Physiotherapeutic Corrective Exercise Program and Standard Physiotherapy Exercise Program in people with Scoliosis Idiopathic Adolescent, run by Alma Mater Europaea - Slovenia at 1 site in Kosovo.

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 6 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 30 Jul 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 Kosovo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in lateral spinal deviation (time frame: Week 16). 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?

On the ClinicalTrials.gov record for NCT07736456, which also lists 2 linked publications.

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 30 Jul 2026.

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