- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06290843
Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Assessment of balance parameters on the AMTI dynanometric platform in children with adolescent idiopathic scoliosis and healthy children in the same age group. Each person examined will have one trial measurement, followed by a 3-minute break. After the trial measurement, the actual examination will take place - 3 trials of 60 seconds each in 4 different variants: eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.The variants will be randomized.
Assessment of body posture using photo recordings taken with an OLYMPUS digital camera, which will be used to classify the type of scoliosis. Anthropometric points will be marked using a washable marker: cervical-thoracic junction C7-Th1, thoracic-lumbar junction Th12/L1, lumbosacral junction L5/S1, right and left anterior superior iliac spine (ASIS), right and left posterior superior iliac spine ( PSIS), the center of the right and left greater trochanters and the center of the lateral malleolus. Photo registration will be made in four positions: front, back, right side and left side. The camera is 3 m away from the subject and the height of the tripod is half the height of the body.
Analysis of spine X-ray images: Cobb angle, Schroth type of scoliosis, Bordering vertebrae, Apex vertebra, Vertebral rotation, Sagittal plane analysis
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: dr Paulina Ewertowska
- Phone Number: 0048 500157143
- Email: paulina.ewertowska@awf.gda.pl
Study Contact Backup
- Name: Kacper Tuptanowski
- Phone Number: 0048 537778870
- Email: tcz.kacper@wp.pl
Study Locations
-
-
Pomorskie
-
Gdańsk, Pomorskie, Poland, 80-336
- Gdansk University of Physical Education and Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Idiopathic adolescent scoliosis aged 10-18 years, female,
- control group aged 10-18 years, female.
Exclusion Criteria:
- congenital spine defects,
- spine surgeries,
- neurological diseases,
- cardiological diseases,
- genetic diseases,
- rheumatological diseases,
- immunological diseases,
- endocrine diseases
- back pain,
- lower limb pain,
- past injuries of lower limbs or spine
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Scoliosis
Children with idiopathic scoliosis
|
Exercises from Schoth method
|
Control
Children without idiopathic scoliosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of body balance on the AMTI force platform
Time Frame: Before and after 12-week therapy
|
The measurement of center of pressure (anterior-posterior) (cm) in standing position with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
|
Before and after 12-week therapy
|
Analysis of body balance on the AMTI force platform
Time Frame: Before and after 12-week therapy
|
Center of pressure (medial-lateral) (cm) in standing position with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
|
Before and after 12-week therapy
|
Analysis of body balance on the AMTI force platform
Time Frame: Directly before and after 12-week therapy
|
Velocity (m/s) of center of pressure changes with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
|
Directly before and after 12-week therapy
|
Analysis of body balance on the AMTI force platform
Time Frame: Directly before and after 12-week therapy
|
Sway area (cm2) of center of pressure with eyes open, eyes closed, single leg left lower limb eyes open, single leg right lower limb eyes open.
|
Directly before and after 12-week therapy
|
Photographic analysis of body posture
Time Frame: Directly before and after 12-week therapy
|
The photos will be taken in various positions: front, back and both sides.
|
Directly before and after 12-week therapy
|
Analysis of x-ray in the frontal plane
Time Frame: One-time examintation before therapy
|
Cobb angle (degree)
|
One-time examintation before therapy
|
Analysis of x-ray in the frontal plane
Time Frame: One-time examintation before therapy
|
Bordering vertebrae (no.)
|
One-time examintation before therapy
|
Analysis of x-ray in the frontal plane
Time Frame: One-time examintation before therapy
|
Apex vertebra (no.)
|
One-time examintation before therapy
|
Analysis of x-ray in the frontal plane
Time Frame: One-time examintation before therapy
|
Vertebral rotation (degree)
|
One-time examintation before therapy
|
Analysis of x-ray in the sagittal plane
Time Frame: One-time examintation before therapy
|
Kyphosis angle (degree)
|
One-time examintation before therapy
|
Analysis of x-ray in the sagittal plane
Time Frame: One-time examintation before therapy
|
Lordosis angle (degree)
|
One-time examintation before therapy
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paulina Ewertowska, Akademia Wychowania Fizycznego i Sportu w Gdańsku
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWFiS/2024_1_PE
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.
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