- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425886
Six-Month Therapeutic Program and Trunk Rotation in Girls Aged 8-11
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lublin Voivodeship
-
Biała Podlaska, Lublin Voivodeship, Poland, 21-500
- Józef Piłsudski University of Physical Education in Warsaw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- ATR below 3 and/or above 6 degrees
- visible structural abnormalities
- neurological, neuromuscular or cardiovascular diseases
- congenital defects
- scoliosis
- Scheuermann's disease
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group corrective gymnastics
Girls aged 8-11 with ATR 3-6 degrees (5-6 people) (n=21).
|
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.
|
|
Experimental: Indywidual Therapy: FITS method
Girls aged 8-11 with ATR 3-6 degrees (n=22).
|
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.
|
|
No Intervention: Observational group
Girls aged 8-11 with ATR 3-6 degrees (n=22).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 month
|
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wioleta Chwalewska, MS, Józef Piłsudski University of Physical Education in Warsaw
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 01-38/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trunk Asymmetry in Children
-
University of FaisalabadEnrolling by invitation
-
Cairo UniversityActive, not recruitingCorrelation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral PalsyEgypt
-
West China HospitalCompletedHydrocephalus in ChildrenChina
-
Montefiore Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)RecruitingAsthma in ChildrenUnited States
-
Universitair Ziekenhuis BrusselCompletedHospitalization in ChildrenBelgium
-
Nisa Meriç TuranActive, not recruitingHospitalization in ChildrenTurkey
-
The University of Texas Health Science Center,...WithdrawnHospitalism in ChildrenUnited States
-
Shriners Hospitals for ChildrenCompletedEnergy Expenditure in Burn Children | Protein Turnover in Burn ChildrenUnited States
-
Mahidol UniversityMurdoch Childrens Research InstituteNot yet recruitingPostoperative Recovery in ChildrenThailand
-
University Hospital, ToulouseUniversity Hospital, LimogesNot yet recruitingCannabis Intoxication in Children
Clinical Trials on Group corrective gymnastics
-
Zeng ChanghaoThe First Affiliated Hospital of Zhengzhou UniversityWithdrawnParkinson DiseaseChina
-
University of Novi SadCompletedExercise | Child Development | Motor ActivitySerbia
-
The First Affiliated Hospital of Zhejiang Chinese...RecruitingAdolescent Idiopathic ScoliosisChina
-
Johannes Kepler University of LinzMedical University of GrazCompleted
-
Fondation Mederic AlzheimerMalakoff-Humanis; Siel BleuCompletedDementia | Relation, FamilyFrance
-
University Hospital, Basel, SwitzerlandCompletedKnee OsteoarthritisSwitzerland
-
Copka SonpashanNot yet recruiting
-
MuhammadNot yet recruiting
-
Istinye UniversityRecruitingScoliosis Idiopathic Adolescent Treatment | Scoliosis Idiopathic AdolescentTurkey (Türkiye)
-
Cairo UniversityCompletedChronic Ankle Instability, CAIEgypt