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NCT Number: NCT05871216

Functional Instability 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"

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Key information

Conditions

Hypermobility Syndrome Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Danlos Disease, Ehlers Ehlers-Danlos Syndrome Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Joint Diseases Joint Hypermobility Joint Instability Laxity of Ligament Musculoskeletal Diseases Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS-Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Maria Grazia Benedetti, MD

CONTACT

[email protected]

+390516366236

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Clinical tests and balance evaluation using the Delos Proprioceptive System

Diagnostic Test

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.

Primary outcomes

Assessing proprioception and postural control

Time frame: baseline

Assessing proprioception and postural control using the Delos Proprioceptive System to obtain static and dynamic stability indicators

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Grazia Benedetti, MD

CONTACT

[email protected]

+39 051 6366236

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: VIPIA

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: May 23, 2023
Registry last updated: Jul 20, 2025

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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