Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data (4FRAILTY)

I

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Osteogenesis Imperfecta

Treatments

Other: experimental

Study type

Interventional

Funder types

Other

Identifiers

NCT06193642
4FRAILTY

Details and patient eligibility

About

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

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

8 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

experimental
Experimental group
Description:
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.
Treatment:
Other: experimental

Trial contacts and locations

1

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Central trial contact

Luca Sangiorgi, MD; Marina Mordenti

Data sourced from clinicaltrials.gov

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