Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility

NCT05871216 | Recruiting

• 1 other identifier: 0006530
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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"

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assessing proprioception and postural control

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

  baseline

Study Arms (1)

Joint Hypermobility Syndrome

Patients suffering from Joint Hypermobility Syndrome with a moderate/severe degree of joint hypermobility (Beighton-Horan Joint Mobility Index score 3-9)

Diagnostic Test: Clinical tests and balance evaluation using the Delos Proprioceptive System

Interventions

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.

Joint Hypermobility Syndrome

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS-Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Collagen Diseases; Joint Instability

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Maria Grazia Benedetti, MD

CONTACT

+39 051 6366236; mariagrazia.benedetti@ior.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: October 1, 2020
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

IT (1)