Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical tests and balance evaluation using the Delos Proprioceptive System.
- Who it may be relevant to
- Registry conditions: Hypermobility Syndrome, Danlos Disease, Ehlers, Collagen Diseases, Joint Hypermobility. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Functional Instability Using the "Delos Proprioceptive System" in Patients Suffering From Collagen Disease and Joint Hypermobility
Overview
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 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.
Primary outcome measures
- Assessing proprioception and postural control [Time frame: baseline]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- IRCCS-Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT05871216 · 0006530