Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility

NCT ID: NCT05871216

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2026-03-30

Brief Summary

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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"

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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)

Clinical tests and balance evaluation using the Delos Proprioceptive System

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS-Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maria Grazia Benedetti, MD

Role: CONTACT

+39 051 6366236

Facility Contacts

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Maria Grazia Benedetti, MD

Role: primary

+390516366236

Other Identifiers

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0006530

Identifier Type: -

Identifier Source: org_study_id

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