Impact of Spinal Curves on Asymmetric Posture in Idiopathic Scoliosis (ISAPIS)

Does the Presence and Type of Curves Influence the Choice of Asymmetric Postures Adopted in Daily Life by Patients with Juvenile and Adolescent Idiopathic Scoliosis?

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

Study Overview

• Status: Active, not recruiting
• Conditions: Adolescent Idiopathic Scoliosis (AIS); Juvenile Idiopathic Scoliosis

• Study Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20141
    • ISICO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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

Description

Scoliosis group:

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Diagnosis of secondary scoliosis
• Patients with neuromotor control disorders

Control group:

Inclusion criteria:

• 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.

Exclusion Criteria:

- Patients with neuromotor control disorders

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 5461_20.11.2024_P_bis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be uploaded on a public repository (Zenodo)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No