ClinicalTrials.gg
RecruitingNCT05871216VIPIAUpdated Jul 20, 2025

Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility

An observational study in Hypermobility Syndrome, Danlos Disease, Ehlers and Collagen Diseases, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-20.

Sponsored by Istituto Ortopedico Rizzoli · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
30
Ages
18 Years to 60 Years
Sex
All
01

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"

02

Conditions studied

  • Hypermobility Syndrome
  • Danlos Disease, Ehlers
  • Collagen Diseases
  • Joint Hypermobility
  • Laxity of Ligament
03

In context

Ehlers-Danlos Syndrome

66 studies on the registry are indexed under Ehlers-Danlos Syndrome; 24 are open to participants now.

This study's planned enrollment of 30 is below the median of 153 across 32 observational studies indexed under Ehlers-Danlos Syndrome.

Browse Ehlers-Danlos Syndrome studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Obesity ( > 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testClinical 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.

06

What researchers measure

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

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2020 (actual). Primary completion is estimated for Mar 2026, 65 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2023
First posted
May 23, 2023
StartActual
Oct 1, 2020
Primary completionEst.
Mar 30, 2026
CompletionEst.
Mar 30, 2026
Last update
Jul 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05871216
Responsible party
Sponsor
First posted
May 23, 2023
Start date
Oct 1, 2020
Primary completion
Mar 30, 2026 (estimated)
Completion
Mar 30, 2026 (estimated)
Last update
Jul 20, 2025

Study contacts

Maria Grazia Benedetti, MD
Contact
mariagrazia.benedetti@ior.it
+39 051 6366236

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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