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Self-correction Evaluation in Scoliosis Patients

Sponsor
Istituto Scientifico Italiano Colonna Vertebrale (Other)
Overall Status
Recruiting
CT.gov ID
NCT05598021
Collaborator
(none)
185
Enrollment
1
Location
5.8
Anticipated Duration (Months)
31.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis.

The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction.

Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session.

Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    185 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Instrumental Evaluation of Self-correction in Patients With Juvenile and Adolescent
    Actual Study Start Date :
    Oct 5, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Ultrasound assessment

    Quantitative comparison between ultrasound images performed in active self-correction and in a spontaneous position
    RX assessment

    Quantitative comparison between radiological images performed in active self-correction and in a spontaneous position

    Outcome Measures

    Primary Outcome Measures

    1. Self-correction measure [through study completion, an average of 6 months]

      The angular difference of the curves resulting from the detection with Scolioscan or Rx in the spontaneous position compared to what was obtained in the same condition but in the self-correcting position.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria for both parts:

    • Diagnosis of juvenile or adolescent idiopathic scoliosis;

    • Age >= 10 years;

    • Single and double curves with amplitude >= 15 ° Cobb;

    • Performing exercises according to SEAS for at least 6 months

    Only for part 1 (radiographic)

    • Availability of radiographic investigation in upright position and in self-correction Only for part 2 (ultrasound)

    • Availability of ultrasound assessment in upright position and in self-correction

    • Complete radiograph of the spine in anteroposterior projection performed in the 45 days preceding or following the medical examination.

    • Risser between 0 and 2.

    Exclusion Criteria:
    For both parts:

    • Patients with more than 2 scoliotic curves

    • Patients with secondary scoliosis

    • Patients suffering from learning disabilities or clinical conditions impairing neuromotor control

    • Patients lacking the necessary measures to evaluate the outcome.

    Part 2 only (ultrasound)

    ● Patients undergoing brace treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ISICO Milan Mi Italy 20141

    Sponsors and Collaborators

    • Istituto Scientifico Italiano Colonna Vertebrale

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Scientifico Italiano Colonna Vertebrale
    ClinicalTrials.gov Identifier:
    NCT05598021
    Other Study ID Numbers:
    • Self-correction
    First Posted:
    Oct 28, 2022
    Last Update Posted:
    Oct 28, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Scoliosis

    Study Results

    No Results Posted as of Oct 28, 2022