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Completed

NCT Number: NCT06290843

Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis

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.

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Key information

Conditions

Idiopathic Scoliosis

Age range

10 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Gdansk University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Schroth method

Procedure

Exercises from Schoth method

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Analysis of x-ray in the frontal plane

    Time frame: One-time examintation before therapy

    Cobb angle (degree)

  7. Analysis of x-ray in the frontal plane

    Time frame: One-time examintation before therapy

    Bordering vertebrae (no.)

  8. Analysis of x-ray in the frontal plane

    Time frame: One-time examintation before therapy

    Apex vertebra (no.)

  9. Analysis of x-ray in the frontal plane

    Time frame: One-time examintation before therapy

    Vertebral rotation (degree)

  10. Analysis of x-ray in the sagittal plane

    Time frame: One-time examintation before therapy

    Kyphosis angle (degree)

  11. Analysis of x-ray in the sagittal plane

    Time frame: One-time examintation before therapy

    Lordosis angle (degree)

Sponsors and collaborators

Lead sponsor

Gdansk University of Physical Education and Sport

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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