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Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06193642
Acronym
4FRAILTY
Enrollment
33
Registered
2024-01-05
Start date
2023-01-20
Completion date
2025-01-13
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteogenesis Imperfecta

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

Interventions

OTHERexperimental

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.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gait-Analysisthrough study completion, an average of 1 yearParameter detection via specific sensors including Inertial Motion Units

Secondary

MeasureTime frameDescription
quality of life questionnairesthrough study completion, an average of 1 yearquality of life assessment

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026