Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility

Hypermobility Syndrome Clinical Trial

— VIPIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871216
• Other study ID #: 0006530
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Maria Grazia Benedetti, MD
• Phone: +39 051 6366236
• Email: mariagrazia.benedetti[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Collagen Diseases
• Ehlers-Danlos Syndrome
• Hypermobility Syndrome
• Joint Hypermobility
• Joint Instability
• Rheumatic Diseases

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS-Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing proprioception and postural control	Assessing proprioception and postural control using the Delos Proprioceptive System to obtain static and dynamic stability indicators	baseline