Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis

Idiopathic Scoliosis Clinical Trial

Official title:

Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290843
• Other study ID #: AWFiS/2024_1_PE
• Status: Not yet recruiting
• Start date: April 5, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: January 2024
• Source: Gdansk University of Physical Education and Sport
• Contact: dr Paulina Ewertowska
• Phone: 500157143
• Email: paulina.ewertowska[@]awf.gda.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Procedure:
• Schroth method
Exercises from Schoth method

Locations

Country	Name	City	State
Poland	Gdansk University of Physical Education and Sport	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Gdansk University of Physical Education and Sport

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of body balance on the AMTI force platform	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
Primary	Analysis of body balance on the AMTI force platform	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
Primary	Analysis of body balance on the AMTI force platform	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
Primary	Analysis of body balance on the AMTI force platform	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
Primary	Photographic analysis of body posture	The photos will be taken in various positions: front, back and both sides.	Directly before and after 12-week therapy
Primary	Analysis of x-ray in the frontal plane	Cobb angle (degree)	One-time examintation before therapy
Primary	Analysis of x-ray in the frontal plane	Bordering vertebrae (no.)	One-time examintation before therapy
Primary	Analysis of x-ray in the frontal plane	Apex vertebra (no.)	One-time examintation before therapy
Primary	Analysis of x-ray in the frontal plane	Vertebral rotation (degree)	One-time examintation before therapy
Primary	Analysis of x-ray in the sagittal plane	Kyphosis angle (degree)	One-time examintation before therapy
Primary	Analysis of x-ray in the sagittal plane	Lordosis angle (degree)	One-time examintation before therapy