Scoliosis Idiopathic Adolescent TreatmentNCT07285551
Physiotherapy and Whole-Body Vibration in Adolescent Idiopathic Scoliosis
A study testing Rigo Concept group and Rigo Concept with whole-body vibration group in people with Scoliosis Idiopathic Adolescent Treatment and Whole-body Vibration, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial summary
The aim of this study is to assess how physiotherapy based on the Rigo Concept, combined with WBV, affects sagittal spinal curvatures, the angle of trunk rotation (ATR), and trunk symmetry in girls with AIS. Participants undergo a 5-day individualized physiotherapy program. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic Adolescent Treatment, Whole-body Vibration
- What is being tested?
- Rigo Concept group and Rigo Concept with whole-body vibration group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 15 Feb 2026to 25 Feb 2026
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinical diagnosis of the adolescent idiopathic scoliosis
- Written consent of a medical doctor for participation
- Female
Who cannot join
- thrombosis
- body implants
- musculoskeletal inflammation
- arthropathy
- tendonitis
- hernia
Show all 20Show fewer
- disc herniation
- recent fractures
- kidney stones
- recent scars
- surgery
- rheumatoid arthritis
- neuropathy
- epilepsy
- previous spinal surgery
- injuries in the spine during the past six months
- injuries in the lower limbs during the past six months
- pain in the spine during the past six months
- pain in the lower limbs during the past six months
- for group with WBV additionally discomfort or felt unwell during vibration exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Specific Physiotherapy and Whole-Body Vibration on Spinal Parameters in Patients With Adolescent Idiopathic Scoliosis
The aim of this study is to assess how physiotherapy based on the Rigo Concept, combined with WBV, affects sagittal spinal curvatures, the angle of trunk rotation (ATR), and trunk symmetry in girls with AIS.
Participants undergo a 5-day individualized physiotherapy program. The exercises follow the four general principles of the Rigo Concept: three-dimensional postural correction, expansion technique, muscle activation, and integration. Therapy is delivered for 3 hours per day, with three 15-minute breaks. Additionally, participants in the Rigo Concept with WBV group perform exercises in a standing position using two poles while exposed to WBV on a Galileo Med 35 platform (Novotec Medical GmbH, Pforzheim, Germany) at a frequency of 25 Hz, with a peak-to-peak displacement of 2 mm. Each session includes three 3-minute bouts of vibration, with 3-minute rests between them. During WBV, participants perform exercises according to the principles of the Rigo Concept.
- Being tested
- Rigo Concept group, Rigo Concept with whole-body vibration group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigo Concept groupProcedure or surgery
5-day physiotherapy based on the Rigo Concept. It has four general principles of correction such as three-dimensional stable postural correction, expansion technique, muscle activation, and integration. Intervention last for 3 hours per day.
Rigo Concept with whole-body vibration groupProcedure or surgery
The same like in the Rigo Concept groupa and additionally in standing position with two poles from Rigo Concept they will be exposed to WBV on a Galileo Med25 platform. WBV will administer in 3 x 3-minute sessions per day at a frequency of 25 Hz and an amplitude of 2 mm.
| Study group | Role | What they receive |
|---|---|---|
| Rigo Concept group | Active comparator | Physiotherapy/exercieses according to the Rigo Concept, 5 days, 3 hour per day Receives: Procedure: Rigo Concept group |
| Rigo Concept with whole-body vibration group | Experimental | Physiotherapy/exercises according to the Rigo Concept combined with whole-body vibration, 5 days, 3 hour per day, supplemented with 3 x 3 minutes of WBV, frequency 25 Hz, amplitude 2 mm Receives: Procedure: Rigo Concept with whole-body vibration group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of the sagittal curvature of the spine
The examination of spinal curvatures (degrees) in the sagittal plane is conducted using a Baseline digital inclinometer (MVS in Motion, Belgium). Measurements are taken in a relaxed standing position. The assessment includes evaluation of thoracic kyphosis (upper and lower parts), lumbar lordosis, and sacral slope. The procedure is as follows: 1) Thoracic kyphosis - the inclinometer is zeroed at the thoracolumbar junction (Th12-L1), and the value is recorded at the cervicothoracic junction (C7-Th1); 2) Lumbar lordosis - the inclinometer is zeroed at the lumbosacral junction (L5-S1), and the value is recorded at the thoracolumbar junction (Th12-L1); 3) Sacral slope - the inclinometer is zeroed in the horizontal position, and the value is recorded at the lumbosacral junction (L5-S1).
Measured: Before the first physiotherapy session and three hours after the last physiotherapy session
Measurements of the trunk symmetry
For postural alignment (centimeters), the physician positions a plumb line at the level of the occipital prominence. Measurements are performed using a rigid millimeter ruler and are rounded to the nearest 0 or 5 mm, assessing the distance from the plumb line to the gluteal cleft. For the assessment of scapular height asymmetry, the inferior angles of the scapulae are marked bilaterally. A rigid ruler is placed across these points, and a scoliometer is positioned on the ruler to record the angle of inclination (degrees). The distances from the inferior angles of the scapulae to the line of spinous processes are measured on both the left and right sides using a rigid ruler, and the differences (centimeters) are then calculated.
Measured: Before the first physiotherapy session and three hours after the last physiotherapy session
Measurements of the angle of trunk rotation
The measurements of the angle of trunk rotation in the transverse plane are conducted using a Baseline scoliometer (MoVeS, Poland). The angle of trunk rotation is assessed during the Adams forward bend test. The participant stands in a relaxed upright position and is instructed to keep their hands together and slowly bend forward, aiming their hands toward the center of support. The examiner records the angle (degrees) and direction (left/right) of trunk rotation at the proximal and main thoracic spine, thoracolumbar region, lumbar spine, and at the level of the posterior superior iliac spine.
Measured: Before the first physiotherapy session and three hours after the last physiotherapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Feb 2026
- Primary completion20 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic Adolescent TreatmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulina Ewertowska, Study chair, Gdansk University of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285551
- Sponsor's protocol ID
- AWFiS/2025_11_PE
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Specific Physiotherapy and Whole-Body Vibration on Spinal Parameters in Patients With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07285551
- Acronym / sponsor ID
- AWFiS/2025_11_PE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 16 Dec 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 aim of this study is to assess how physiotherapy based on the Rigo Concept, combined with WBV, affects sagittal spinal curvatures, the angle of trunk rotation (ATR), and trunk symmetry in girls with AIS.
Participants undergo a 5-day individualized physiotherapy program. The exercises follow the four general principles of the Rigo Concept: three-dimensional postural correction, expansion technique, muscle activation, and integration. Therapy is delivered for 3 hours per day, with three 15-minute breaks. Additionally, participants in the Rigo Concept with WBV group perform exercises in a standing position using two poles while exposed to WBV on a Galileo Med 35 platform (Novotec Medical GmbH, Pforzheim, Germany) at a frequency of 25 Hz, with a peak-to-peak displacement of 2 mm. Each session includes three 3-minute bouts of vibration, with 3-minute rests between them. During WBV, participants perform exercises according to the principles of the Rigo Concept.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rigo Concept group | Active comparator | Procedure: Rigo Concept groupPhysiotherapy/exercieses according to the Rigo Concept, 5 days, 3 hour per day |
| Rigo Concept with whole-body vibration group | Experimental | Procedure: Rigo Concept with whole-body vibration groupPhysiotherapy/exercises according to the Rigo Concept combined with whole-body vibration, 5 days, 3 hour per day, supplemented with 3 x 3 minutes of WBV, frequency 25 Hz, amplitude 2 mm |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of the adolescent idiopathic scoliosis
- Written consent of a medical doctor for participation
- Female
Key exclusion criteria (20 listed)
- thrombosis
- body implants
- musculoskeletal inflammation
- arthropathy
- tendonitis
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 |
|---|---|---|
| Rigo Concept group5-day physiotherapy based on the Rigo Concept. It has four general principles of correction such as three-dimensional stable postural correction, expansion technique, muscle activation, and integration. Intervention last for 3 hours per day. | Procedure or surgery | Rigo Concept group |
| Rigo Concept with whole-body vibration groupThe same like in the Rigo Concept groupa and additionally in standing position with two poles from Rigo Concept they will be exposed to WBV on a Galileo Med25 platform. WBV will administer in 3 x 3-minute sessions per day at a frequency of 25 Hz and an amplitude of 2 mm. | Procedure or surgery | Rigo Concept with whole-body vibration group |
Primary outcome
Measurements of the sagittal curvature of the spine
Time frame: Before the first physiotherapy session and three hours after the last physiotherapy session
The examination of spinal curvatures (degrees) in the sagittal plane is conducted using a Baseline digital inclinometer (MVS in Motion, Belgium). Measurements are taken in a relaxed standing position. The assessment includes evaluation of thoracic kyphosis (upper and lower parts), lumbar lordosis, and sacral slope. The procedure is as follows: 1) Thoracic kyphosis - the inclinometer is zeroed at the thoracolumbar junction (Th12-L1), and the value is recorded at the cervicothoracic junction (C7-Th1); 2) Lumbar lordosis - the inclinometer is zeroed at the lumbosacral junction (L5-S1), and the value is recorded at the thoracolumbar junction (Th12-L1); 3) Sacral slope - the inclinometer is zeroed in the horizontal position, and the value is recorded at the lumbosacral junction (L5-S1).
Measurements of the trunk symmetry
Time frame: Before the first physiotherapy session and three hours after the last physiotherapy session
For postural alignment (centimeters), the physician positions a plumb line at the level of the occipital prominence. Measurements are performed using a rigid millimeter ruler and are rounded to the nearest 0 or 5 mm, assessing the distance from the plumb line to the gluteal cleft. For the assessment of scapular height asymmetry, the inferior angles of the scapulae are marked bilaterally. A rigid ruler is placed across these points, and a scoliometer is positioned on the ruler to record the angle of inclination (degrees). The distances from the inferior angles of the scapulae to the line of spinous processes are measured on both the left and right sides using a rigid ruler, and the differences (centimeters) are then calculated.
Measurements of the angle of trunk rotation
Time frame: Before the first physiotherapy session and three hours after the last physiotherapy session
The measurements of the angle of trunk rotation in the transverse plane are conducted using a Baseline scoliometer (MoVeS, Poland). The angle of trunk rotation is assessed during the Adams forward bend test. The participant stands in a relaxed upright position and is instructed to keep their hands together and slowly bend forward, aiming their hands toward the center of support. The examiner records the angle (degrees) and direction (left/right) of trunk rotation at the proximal and main thoracic spine, thoracolumbar region, lumbar spine, and at the level of the posterior superior iliac spine.
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 5 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Scoliosis Idiopathic Adolescent Treatment
Active, not recruiting
Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Quality of Life, Psychosocial Burden, and Structural-functional Status in Adults With Spinal Deformity.
ASD, Scoliosis Idiopathic Adolescent
Active, not recruitingObservational study
Real-World Effectiveness of Conservative Treatment in Idiopathic Scoliosis
Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
Recruiting
The Use of a Comfort Tote to Improve Recovery in Pediatric and Adolescent Patients After Surgery
Adolescent Idiopathic Scoliosis, Postoperative Pain, Acute
Active, not recruiting
Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
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.
Paulina Ewertowska study chair
Gdansk University of Physical Education and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigo Concept group and Rigo Concept with whole-body vibration group in people with Scoliosis Idiopathic Adolescent Treatment and Whole-body Vibration, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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 3 inclusion and 20 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 5 Mar 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 Poland. 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?
Measurements of the sagittal curvature of the spine (time frame: Before the first physiotherapy session and three hours after the last physiotherapy session). The study lists 3 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 5 Mar 2026.