Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

NCT ID: NCT06193642

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2028-11-30

Brief Summary

interventional pilot study with the enrollment of patients affected by Osteogenesis Imperfecta

Detailed Description

Subjects diagnosed with Osteogenesis Imperfecta will be undergoing, after collection of informed consent, to a series of assessments using sensor imaging and Gait-Analysis and collection of specific parameters

Conditions

Osteogenesis Imperfecta

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

experimental

Through gait analysis acquisition sessions in the most comprehensive configuration possible on a test group of patients, the aim is to identify measures to be collected at regime for simplified evaluation including patient acceptability.

Patients will be asked to complete quality of life questionnaires.

Group Type: EXPERIMENTAL

experimental

Intervention Type: OTHER

Subjects diagnosed with OI will undergo a series of assessments using sensor imaging and Gait-Analysis; we will proceed with a careful and detailed collection, analysis and evaluation of functional data typical of Gait-Analysis studies, aimed at identifying that subset of parameters that will prove most interesting and useful for the purposes of the study, thus identifying the sensors and algorithms that can precisely produce the most usable synthetic information for defining the quality of motor function in these patients.

Interventions

experimental

Subjects diagnosed with OI will undergo a series of assessments using sensor imaging and Gait-Analysis; we will proceed with a careful and detailed collection, analysis and evaluation of functional data typical of Gait-Analysis studies, aimed at identifying that subset of parameters that will prove most interesting and useful for the purposes of the study, thus identifying the sensors and algorithms that can precisely produce the most usable synthetic information for defining the quality of motor function in these patients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with Osteogenesis Imperfecta (clinical diagnosis) able to perform the gait-analysis movement data acquisition session, in the most complete instrumental configuration, i.e., with kinematics, dynamics and electromyography; it will naturally be evaluated which motor tasks are safely executable and which are not.
• All patients of both sexes will be included
• Patients in the age range: 8-60 will be included

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Countries

Italy

References

Colnaghi S, Rezzani C, Gnesi M, Manfrin M, Quaglieri S, Nuti D, Mandala M, Monti MC, Versino M. Validation of the Italian Version of the Dizziness Handicap Inventory, the Situational Vertigo Questionnaire, and the Activity-Specific Balance Confidence Scale for Peripheral and Central Vestibular Symptoms. Front Neurol. 2017 Oct 10;8:528. doi: 10.3389/fneur.2017.00528. eCollection 2017.

Reference Type: RESULT

PMID: 29066999 (View on PubMed)

Benedetti MG, Catani F, Leardini A, Pignotti E, Giannini S. Data management in gait analysis for clinical applications. Clin Biomech (Bristol). 1998 Apr;13(3):204-215. doi: 10.1016/s0268-0033(97)00041-7.

Reference Type: RESULT

PMID: 11415789 (View on PubMed)

Other Identifiers

4FRAILTY

Identifier Type: -

Identifier Source: org_study_id