Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

NCT06193642 | Completed

• 1 other identifier: 4FRAILTY
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteogenesis Imperfecta

Outcome Measures

Primary Outcomes (1)

• Gait-Analysis

  Parameter detection via specific sensors including Inertial Motion Units

  through study completion, an average of 1 year

Secondary Outcomes (1)

• quality of life questionnaires

  through study completion, an average of 1 year

Study Arms (1)

experimental

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.

Other: experimental

Interventions

experimental 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.

experimental

Eligibility Criteria

• Age: 8 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (2)

• 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.

  PMID: 29066999 RESULT

• 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.

  PMID: 11415789 RESULT

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: January 5, 2024
• Study Start: January 20, 2023
• Primary Completion: November 30, 2024
• Study Completion: January 13, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

IT (1)