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Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05871216
Acronym
VIPIA
Enrollment
30
Registered
2023-05-23
Start date
2020-10-01
Completion date
2026-03-30
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Collagen Diseases, Danlos Disease, Ehlers, Hypermobility Syndrome, Joint Hypermobility, Laxity of Ligament

Brief summary

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

Interventions

DIAGNOSTIC_TESTClinical 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.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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)

Design outcomes

Primary

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

Countries

Italy

Contacts

Primary ContactMaria Grazia Benedetti, MD
mariagrazia.benedetti@ior.it+39 051 6366236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026