Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility (VIPIA)

Evaluation of Functional Instability Using the "Delos Proprioceptive System" in Patients Suffering From Collagen Disease and Joint Hypermobility

A joint is considered "hypermobile" when it has a greater range of motion than normal for a given age, ethnicity or gender. Many people have asymptomatic hyperlaxity in multiple joints, a condition called Generalized Joint Hypermobility (GJH).

Conversely, hyperlaxity can be symptomatic, a condition that has been defined "Joint Hypermobility Syndrome" - JHS.

Diagnosis of JHS is commonly performed by applying the revised Brighton criteria. Based on these criteria, an individual is diagnosed with JHS with a Beighton score >/= 4/9, and arthralgia for 3 or more months in 4 or more joints (major criteria).

The dynamic body balance test (i.e. the stability test with multiple single-leg jumps) can provide information regarding the effectiveness of the feedforward and feedback mechanisms in correcting the postural deviations necessary to achieve successful performance during daily and sporting activities. Such assessment may also be useful to demonstrate deficiencies in balance, especially in young patients with increased physical activity.

The aim of this study is to examine the postural balance of individuals with JHS by performing stability tests in monopodalic and bipodalic stance with the "Delos Postural Proprioceptive System"

Study Overview

• Status: Recruiting
• Conditions: Collagen Diseases; Joint Hypermobility; Hypermobility Syndrome; Laxity of Ligament; Danlos Disease, Ehlers
• Intervention / Treatment: Diagnostic test: Clinical tests and balance evaluation using the Delos Proprioceptive System

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Maria Grazia Benedetti, MD; Phone Number: +39 051 6366236; Email: mariagrazia.benedetti@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • IRCCS-Istituto Ortopedico Rizzoli
    • Contact: Maria Grazia Benedetti, MD; Phone Number: +390516366236; Email: mariagrazia.benedetti@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate (Beighton-Horan Joint Mobility Index score from 3 to 4) or severe (Beighton-Horan Joint Mobility Index score from 5 to 9) joints hyperlaxity at the clinical evaluation

Description

Inclusion Criteria:

• Patients with moderate (Beighton-Horan Joint Mobility Index score from 3 to 4) or severe (Beighton-Horan Joint Mobility Index score from 5 to 9) joints hyperlaxity at the clinical evaluation

Exclusion Criteria:

• Obesity (BMI > 25) and weight > 90 kg
• Practice of competitive sport
• Orthopedic (complex surgery of the spine and lower limbs), neurological (spasticity, stroke), and oncological comorbidities
• Orthostatic / walking inability
• Absence of joints hyperlaxity at the clinical evaluation (Beighton-Horan Joint Mobility Index score from 0 to 2)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Joint Hypermobility Syndrome; Patients suffering from Joint Hypermobility Syndrome with a moderate/severe degree of joint hypermobility (Beighton-Horan Joint Mobility Index score 3-9)	Diagnostic test: Clinical tests and balance evaluation using the Delos Proprioceptive System; Each patient is evaluated using clinical tests (Time up and go test, 6 minutes walking test), scales (BORG scale, Beighton score), and the ''Delos Proprioceptive System'' to assess balance control and proprioception with bipodalic and monopodalic tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing proprioception and postural control	Assessing proprioception and postural control using the Delos Proprioceptive System to obtain static and dynamic stability indicators	baseline

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Hemostatic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Rheumatic Diseases; Collagen Diseases; Joint Instability; Ehlers-Danlos Syndrome
• Other Study ID Numbers: 0006530

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No