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Recruiting Observational

Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility

NCT05871216 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2020-10-01
Last updated
2025-07-20

Condition(s) studied

Hypermobility SyndromeDanlos Disease, EhlersCollagen DiseasesJoint HypermobilityLaxity of Ligament

Investigational drug(s) / intervention(s)

Clinical tests and balance evaluation using the Delos Proprioceptive System

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.

Study 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"

Eligibility

Sex
ALL
Min age
18 Years
Max age
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)

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
IRCCS-Istituto Ortopedico Rizzoli Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05871216 on ClinicalTrials.gov ↗ ← All trials in Italy