ClinicalTrials.gg
CompletedNCT061936424FRAILTYUpdated May 22, 2026

Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data

An interventional study of experimental in Osteogenesis Imperfecta, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 8 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2023, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
8 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Osteogenesis Imperfecta
03

In context

Osteogenesis Imperfecta

84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.

This study's enrollment of 33 is above the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.

Browse Osteogenesis Imperfecta studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Subjects who do not fit the inclusion criteria
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • 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

  • 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.

06

What researchers measure

Primary outcomes

  1. Gait-Analysis

    Parameter detection via specific sensors including Inertial Motion Units

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

Secondary outcomes

  1. quality of life questionnaires

    quality of life assessment

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

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Study locations

1 site
  • Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
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References and documents

Publications

  • 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. PubMed 29066999 ↗
  • 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. PubMed 11415789 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06193642
Responsible party
Sponsor
First posted
Jan 5, 2024
Start date
Jan 20, 2023
Primary completion
Nov 30, 2024
Completion
Jan 13, 2025
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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