NCT06290843

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 23, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

October 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

February 19, 2024

Last Update Submit

October 29, 2024

Conditions

Idiopathic Scoliosis

Keywords

Spinal deformityAMTI platformBalancePostural stability

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Analysis of x-ray in the frontal plane

    Cobb angle (degree)

    One-time examintation before therapy

  • Analysis of x-ray in the frontal plane

    Bordering vertebrae (no.)

    One-time examintation before therapy

  • Analysis of x-ray in the frontal plane

    Apex vertebra (no.)

    One-time examintation before therapy

  • Analysis of x-ray in the frontal plane

    Vertebral rotation (degree)

    One-time examintation before therapy

  • Analysis of x-ray in the sagittal plane

    Kyphosis angle (degree)

    One-time examintation before therapy

  • Analysis of x-ray in the sagittal plane

    Lordosis angle (degree)

    One-time examintation before therapy

Study Arms (2)

Scoliosis

Children with idiopathic scoliosis

Procedure: Schroth method

Control

Children without idiopathic scoliosis

Procedure: Schroth method

Interventions

Schroth methodPROCEDURE

Exercises from Schoth method

ControlScoliosis

Eligibility Criteria

Age10 Years - 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children aged 11-18 years diagnosed with adolescent idiopathic scoliosis

You may qualify if:

  • Idiopathic adolescent scoliosis aged 10-18 years, female,
  • control group aged 10-18 years, female.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

Location

Study Officials

  • Paulina Ewertowska

    Akademia Wychowania Fizycznego i Sportu w Gdańsku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

March 4, 2024

Study Start

April 23, 2024

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

October 31, 2024

Record last verified: 2024-01

Locations

PL(1)