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Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

Not Applicable
Active, not recruiting
Conditions
Osteogenesis Imperfecta
Interventions
Other: experimental
Registration Number
NCT06193642
Lead Sponsor
Istituto Ortopedico Rizzoli
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

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
33
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
experimentalexperimentalThrough 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.
Primary Outcome Measures
NameTimeMethod
Gait-Analysisthrough study completion, an average of 1 year

Parameter detection via specific sensors including Inertial Motion Units

Secondary Outcome Measures
NameTimeMethod
quality of life questionnairesthrough study completion, an average of 1 year

quality of life assessment

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli

🇮🇹

Bologna, Italy

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