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Completed

NCT Number: NCT06193642

Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

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

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Key information

Conditions

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

Age range

8 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Gait-Analysis

    Time frame: through study completion, an average of 1 year

    Parameter detection via specific sensors including Inertial Motion Units

Secondary outcomes

  1. quality of life questionnaires

    Time frame: through study completion, an average of 1 year

    quality of life assessment

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: 4FRAILTY

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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