NCT05762354

Brief Summary

Scoliosis is a three-dimensional torsional deformation of the spine and trunk. Chest deformity and pelvic asymmetry are often seen together with spinal deformity. Adolescent idiopathic scoliosis occurs from the onset of puberty until growth plate closure and is the most common of all scoliosis. One of the most common deformities among posture disorders is known as scoliosis. The change in load distribution resulting from this three-dimensional deformation causes postural changes in patients with idiopathic scoliosis. According to a study, it is thought that postural control and central information processing efficiency may decrease as the Cobb angle increases in people with scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

February 28, 2023

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fukuda Step Test

    The patient will do a 50 or 100 step counting motion with eyes open and closed. 30 degree rotation or 50 cm displacement for 50 steps relative to the starting position; For 100 steps, 31 turns of 45 degrees and displacement of 100 cm will count as a positive result. The hypoactive side of the labyrinth will be accepted as the patient's turning side. The displacement amount of the person will be measured in cm with the help of a tape measure, and the rotation amount will be measured in degrees with the help of a goniometer and recorded in the evaluation form.

    Baseline

Secondary Outcomes (7)

  • Cobb Degree

    Baseline

  • Trunk Rotation

    Baseline

  • Posterior Trunk Symmetry Index

    Baseline

  • Walter Reed Visual Assessment Scale

    Baseline

  • SRS 22 Questionaire

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

Scoliosis Group

Adolescent Idıopathic Scoliosis

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents Idıopatic Scoliosis

You may qualify if:

  • Having been diagnosed with adolescent idiopathic scoliosis by a doctor,
  • Not having cognitive, mental and psychological problems,
  • Continuing exercise or brace therapy.

You may not qualify if:

  • Having a history of spinal surgery
  • Having a type of scoliosis other than idiopathic,
  • Presence of musculoskeletal system pathologies,
  • Vestibular system disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Gelişim Üniversitesi

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • İrem Kurt, Msc.

    İstanbul Gelişim Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 9, 2023

Study Start

August 26, 2022

Primary Completion

February 10, 2024

Study Completion

February 10, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations