NCT06733623

Brief Summary

Asymmetric postures are often observed in patients with adolescent idiopathic scoliosis (AIS) and are partially associated with instability in sitting and standing positions, as well as with imbalances in gait kinematic parameters in cases of moderate or severe scoliosis. Based on the currently available data, no correlation has been identified between habitual postures in daily life and the presence of scoliosis. However, the asymmetry of preferred postures in relation to the morphological characteristics of the curves, and how this might contribute to the progression of the clinical condition due to prolonged uneven load distribution, has not yet been analyzed. Understanding any preferential direction in postures habitually adopted by patients with idiopathic scoliosis could provide valuable insights for the conservative management of the condition. The aim of this study is to analyze the influence of the morphological characteristics of scoliotic curves (type and laterality) in patients with juvenile and adolescent idiopathic scoliosis on the choice of preferentially maintained asymmetric postures in daily life, using a descriptive questionnaire completed by family members and caregivers, compared to a group of non-scoliotic subjects. Evaluate the effect of curve magnitude, age, sex, and Risser grade on the choice of usual asymmetric postures. Estimate the impact of prolonged maintenance of habitual asymmetric postures on the clinical progression in patients with juvenile and adolescent idiopathic scoliosis

Trial Health

75
On Track

Trial Health Score

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

Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress96%
Dec 2024Jun 2026

First Submitted

Initial submission to the registry

December 10, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

December 10, 2024

Last Update Submit

December 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Everyday posture questionnaire

    The types of postures most frequently maintained in daily life by patients with idiopathic scoliosis will be compared with a group of age-matched individuals without scoliosis, and any statistically significant differences will be analyzed using the chi-square test

    At enrollment

Study Arms (2)

Scoliosis patients

Patients aged between 6 and 18 years old with a diagnosis of idiopathic scoliosis are asked to answer a questionnaire investigating the preferred postures adopted daily

Control group

Subjects aged between 6 and 18 years old without a diagnosis of idiopathic scoliosis are asked to answer a questionnaire investigating the preferred postures adopted daily

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participants of the study are patients of a tertiary referral outpatient clinic specializing in the conservative treatment of spinal deformity

You may qualify if:

  • Diagnosis of juvenile or adolescent idiopathic scoliosis;
  • Age between 6 and 18 years;
  • Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.

You may not qualify if:

  • Diagnosis of secondary scoliosis
  • Patients with neuromotor control disorders
  • Control group:
  • Age between 6 and 18 years;
  • No diagnosis of sciolisis
  • Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.
  • \- Patients with neuromotor control disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISICO

Milan, Italy, 20141, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 13, 2024

Study Start

December 10, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Anonymized data will be uploaded on a public repository (Zenodo)

Locations