Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

Osteogenesis Imperfecta Clinical Trial

— 4FRAILTY  

Official title:

Increasing Knowledge on Osteogenesis Imperfecta by Collecting and Integrating Epidemiological Data, Genetic Information, and Functional Performance From Movement Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193642
• Other study ID #: 4FRAILTY
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: November 30, 2028

Study information

• Verified date: January 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Luca Sangiorgi, MD
• Phone: 05106366
• Email: luca.sangiorgi[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2028
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 60 Years

Eligibility

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

Exclusion Criteria:

• Subjects who do not fit the inclusion criteria

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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

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 Scal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait-Analysis	Parameter detection via specific sensors including Inertial Motion Units	through study completion, an average of 1 year
Secondary	quality of life questionnaires	quality of life assessment	through study completion, an average of 1 year