Trunk Asymmetry in ChildrenNCT07425886
Six-Month Therapeutic Program and Trunk Rotation in Girls Aged 8-11
A study testing Indywidual Therapy: FITS method and Group corrective gymnastics in people with Trunk Asymmetry in Children, run by Wioleta Chwalewska at 1 site in Poland.
Trial summary
The primary assumption of this study is to evaluate the impact of individual and group corrective therapy on changes in body posture in the transverse plane in girls aged 8-11 years diagnosed with posture disorders. Read more about this study
- Who is it for?
- Ages 8 to 11 years, women only
- Conditions the study is for
- Trunk Asymmetry in Children
- What is being tested?
- Indywidual Therapy: FITS method and Group corrective gymnastics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jan 2023to 20 Jun 2024
- 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 11 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- female gender
- age 8-11 years
- before or up to six months after the onset of the first menstruation
- ATR 3-6 degrees
- no diagnosed orthopaedic, neurological or viral diseases
- written consent of parents and/or legal guardians to participate in the project
Who cannot join
- ATR below 3 and/or above 6 degrees
- visible structural abnormalities
- neurological, neuromuscular or cardiovascular diseases
- congenital defects
- scoliosis
- Scheuermann's disease
Show all 14Show fewer
- diagnosed anatomical leg length discrepancy of less than 2.5 cm
- poor psychophysical condition
- elevated body temperature
- back or lower limb surgery
- spina bifida
- intellectual disability
- genetic conditions
- lack of written consent for testing.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Józef Piłsudski University of Physical Education in Warsaw
Biała Podlaska, Lublin Voivodeship, 21-500
About this study
Official title: Results of a 6-month Therapeutic Program Regarding the Angle of Trunk Rotation in Girls Aged 8-11: a Randomized Trial
The primary assumption of this study is to evaluate the impact of individual and group corrective therapy on changes in body posture in the transverse plane in girls aged 8-11 years diagnosed with posture disorders. The aim of the study is to assess the effectiveness of a 6-month intervention consisting of individual physiotherapy conducted in accordance with the principles of the Functional Individual Therapy of Scoliosis (FITS) method and group corrective exercises, compared with observation only.
The study will enable a detailed analysis of changes in the angle of trunk rotation and selected parameters of spinal rotation in the transverse plane in children participating in the intervention. The results obtained may contribute to the evaluation of the clinical usefulness of individual and group physiotherapy programs in the correction of posture disorders and in the early prevention of scoliosis in the pediatric population.
Read the detailed description
The study was conducted in a population of girls aged 8-11 years identified through a school-based screening program for posture disorders. Following the informed consent procedures, 66 girls meeting all eligibility criteria were enrolled in the intervention phase.
Participants were assigned to one of three groups:
- an individual therapy group undergoing physiotherapy in accordance with the principles of Functional Individual Therapy of Scoliosis (FITS),
- a group therapy group participating in group corrective exercises, and
- a control group remaining under observation without therapeutic intervention.
Posture assessment was performed before and after a 6-month intervention period. The angle of trunk rotation was measured using a scoliometer. A three-dimensional, non-invasive assessment of body posture and spinal alignment in the transverse plane was conducted using the DIERS Formetric 4D system. The evaluated parameters included trunk surface rotation, vertebral rotation, and selected rotational parameters of the thoracic and lumbar spine segments.
The individual FITS therapy was conducted according to standardized methodological principles and was tailored to the specific postural characteristics of each participant. Group corrective exercises were performed according to an established corrective exercise program appropriate for children with posture disorders. The observation group did not participate in any structured therapeutic intervention during the study period.
After completion of the 6-month intervention, all baseline measurements were repeated under identical conditions. The collected data allowed for the evaluation of changes in posture parameters within and between groups, enabling an assessment of the effectiveness of individual and group physiotherapy interventions in improving posture disorders and supporting early scoliosis prevention in children.
- Conditions
- Trunk Asymmetry in Children
- Being tested
- Indywidual Therapy: FITS method, Group corrective gymnastics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indywidual Therapy: FITS methodDiagnostic test
The group underwent individual therapy in accordance with the FITS method, adapted to the functional abilities of the patients. The group underwent physiotherapy sessions (once a week, 45 minutes each) and performed home exercises (5 times a week, 30 minutes each) for 6 months.
Group corrective gymnasticsDiagnostic test
The group participated in corrective gymnastics classes, conducted in accordance with generally accepted principles of physical activity and the Guide for Preventive and Corrective Exercises, The group underwent physiotherapy sessions (once a week, 45 minutes each) and performed home exercises (5 times a week, 30 minutes each) for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Group corrective gymnastics | Experimental | Girls aged 8-11 with ATR 3-6 degrees (5-6 people) (n=21). Receives: Diagnostic Test: Group corrective gymnastics |
| Indywidual Therapy: FITS method | Experimental | Girls aged 8-11 with ATR 3-6 degrees (n=22). Receives: Diagnostic Test: Indywidual Therapy: FITS method |
| Observational group | No intervention | Girls aged 8-11 with ATR 3-6 degrees (n=22). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of Trunk Rotation (ATR)
Angle of trunk rotation measured in degrees using a scoliometer during Adam's forward bend test.
Measured: 6 month
Surface Rotation Parameters (DIERS Formetric 3D)
surface rotation assessed using the DIERS Formetric 3D system, including surface rotation (degrees), root mean square of back surface rotation (degrees), and maximum vertebral rotation (degrees) in the thoracic (Th1-Th4, Th5-Th12) and lumbar (L1-L5) spine segments.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start20 Jan 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trunk Asymmetry in ChildrenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wioleta Chwalewska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wioleta Chwalewska, Józef Piłsudski University of Physical Education
- Investigators
- Wioleta Chwalewska, MS, Principal investigator, Józef Piłsudski University of Physical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425886
- Sponsor's protocol ID
- 01-38/2022
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of a 6-month Therapeutic Program Regarding the Angle of Trunk Rotation in Girls Aged 8-11: a Randomized Trial
- ClinicalTrials.gov ID
- NCT07425886
- Acronym / sponsor ID
- 01-38/2022
- Conditions
- Trunk Asymmetry in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Wioleta ChwalewskaUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 23 Feb 2026 (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 primary assumption of this study is to evaluate the impact of individual and group corrective therapy on changes in body posture in the transverse plane in girls aged 8-11 years diagnosed with posture disorders. The aim of the study is to assess the effectiveness of a 6-month intervention consisting of individual physiotherapy conducted in accordance with the principles of the Functional Individual Therapy of Scoliosis (FITS) method and group corrective exercises, compared with observation only.
The study will enable a detailed analysis of changes in the angle of trunk rotation and selected parameters of spinal rotation in the transverse plane in children participating in the intervention. The results obtained may contribute to the evaluation of the clinical usefulness of individual and group physiotherapy programs in the correction of posture disorders and in the early prevention of scoliosis in the pediatric population.
Detailed description
The study was conducted in a population of girls aged 8-11 years identified through a school-based screening program for posture disorders. Following the informed consent procedures, 66 girls meeting all eligibility criteria were enrolled in the intervention phase.
Participants were assigned to one of three groups:
- an individual therapy group undergoing physiotherapy in accordance with the principles of Functional Individual Therapy of Scoliosis (FITS),
- a group therapy group participating in group corrective exercises, and
- a control group remaining under observation without therapeutic intervention.
Posture assessment was performed before and after a 6-month intervention period. The angle of trunk rotation was measured using a scoliometer. A three-dimensional, non-invasive assessment of body posture and spinal alignment in the transverse plane was conducted using the DIERS Formetric 4D system. The evaluated parameters included trunk surface rotation, vertebral rotation, and selected rotational parameters of the thoracic and lumbar spine segments.
The individual FITS therapy was conducted according to standardized methodological principles and was tailored to the specific postural characteristics of each participant. Group corrective exercises were performed according to an established corrective exercise program appropriate for children with posture disorders. The observation group did not participate in any structured therapeutic intervention during the study period.
After completion of the 6-month intervention, all baseline measurements were repeated under identical conditions. The collected data allowed for the evaluation of changes in posture parameters within and between groups, enabling an assessment of the effectiveness of individual and group physiotherapy interventions in improving posture disorders and supporting early scoliosis prevention in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group corrective gymnastics | Experimental | Diagnostic Test: Group corrective gymnasticsGirls aged 8-11 with ATR 3-6 degrees (5-6 people) (n=21). |
| Indywidual Therapy: FITS method | Experimental | Diagnostic Test: Indywidual Therapy: FITS methodGirls aged 8-11 with ATR 3-6 degrees (n=22). |
| Observational group | No intervention | –Girls aged 8-11 with ATR 3-6 degrees (n=22). |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- female gender
- age 8-11 years
- before or up to six months after the onset of the first menstruation
- ATR 3-6 degrees
- no diagnosed orthopaedic, neurological or viral diseases
Key exclusion criteria (14 listed)
- ATR below 3 and/or above 6 degrees
- visible structural abnormalities
- neurological, neuromuscular or cardiovascular diseases
- congenital defects
- scoliosis
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 |
|---|---|---|
| Indywidual Therapy: FITS methodThe group underwent individual therapy in accordance with the FITS method, adapted to the functional abilities of the patients. The group underwent physiotherapy sessions (once a week, 45 minutes each) and performed home exercises (5 times a week, 30 minutes each) for 6 months. | Diagnostic test | Indywidual Therapy: FITS method |
| Group corrective gymnasticsThe group participated in corrective gymnastics classes, conducted in accordance with generally accepted principles of physical activity and the Guide for Preventive and Corrective Exercises, The group underwent physiotherapy sessions (once a week, 45 minutes each) and performed home exercises (5 times a week, 30 minutes each) for 6 months. | Diagnostic test | Group corrective gymnastics |
Primary outcome
Angle of Trunk Rotation (ATR)
Time frame: 6 month
Angle of trunk rotation measured in degrees using a scoliometer during Adam's forward bend test.
Surface Rotation Parameters (DIERS Formetric 3D)
Time frame: 6 months
surface rotation assessed using the DIERS Formetric 3D system, including surface rotation (degrees), root mean square of back surface rotation (degrees), and maximum vertebral rotation (degrees) in the thoracic (Th1-Th4, Th5-Th12) and lumbar (L1-L5) spine segments.
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 23 Feb 2026.
- Individual participant dataSharing planned: Yes
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.
Wioleta Chwalewska, MS principal investigator
Józef Piłsudski University of Physical Education in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indywidual Therapy: FITS method and Group corrective gymnastics in people with Trunk Asymmetry in Children, run by Wioleta Chwalewska 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 6 inclusion and 14 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 23 Feb 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?
Angle of Trunk Rotation (ATR) (time frame: 6 month). 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 23 Feb 2026.