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Presentation of Young Adults With and Without Joint Hypermobility

17 juin 2026 mis à jour par: Leslie Russek, Clarkson University

Prospective Study of Symptoms in People With and Without Joint Hypermobility

People with multiple hypermobile joints are diagnosed with Generalized Joint Hypermobility (GJH) when asymptomatic, or Hypermobile Ehlers-Danlos Syndrome (hEDS) and Hypermobility Spectrum Disorder (HSD) when symptomatic (hEDS/HSD, or 'HSD' here). GJH likely affects about 20% of the U.S. population, while HSD affects 0.5-3% of the US population. Although joint hypermobility is the most visible presentation of HSD, it is a systemic connective tissue disorder affecting multiple body systems. Due to frequent health concerns, HSD may contribute to more than 30% of patients in chronic pain, rheumatology, orthopedic and physical therapy clinics. It is still unclear why some people have asymptomatic hypermobility and others develop complex chronic health issues. However, recent research suggests that the transition might be triggered by severe physiological stress, such as viral infection.

HSD is commonly associated with Postural Orthostatic Tachycardia Syndrome (POTS) and Mast Cell Activation Syndrome (MCAS), as well as gastrointestinal (GI) problems. Recent research suggests that persistent inflammation due to MCAS or COVID may trigger HSD symptoms. The correlation between POTS and HSD may be due to effects of HSD on the autonomic nervous system or to inflammation triggering both conditions. It is also unclear whether body awareness and coordination deficits seen in symptomatic HSD are due to the fundamental connective tissue disorder or due to pain and injuries in HSD. This study seeks to determine whether asymptomatic hypermobile individuals (GJH) also have balance and coordination deficits. The current study hopes to identify factors that correlate with a transition from asymptomatic GJH to symptomatic HSD by following a group of Health Science students forward in time. The study will collect baseline health information including relevant diagnoses, symptoms and function. Physical measurements will include standard clinical tests performed by physical therapists: joint hypermobility and instability, standing balance, neck movement control, and heart rate in response to standing from lying down. The study is likely to last for at least 10 years to follow participants over time.

Aperçu de l'étude

Description détaillée

Most hyper mobility-related research is conducted by clinical researchers, who are generally limited to recruiting research subjects from patients who present to their clinics. There are few opportunities for longitudinal studies of asymptomatic or 'healthy' individuals to identify potential triggers prospectively and to compare to people who do not develop symptoms. A health care academic institution provides the ideal environment for a prospective study, somewhat like the 'Nurses Health Study'* that followed a population of nurses throughout their lives.

The study will collect initial data on:

  • Current diagnoses related to HSD, MCAS, and POTS (questionnaire)
  • Current symptoms associated with HSD, MCAS and POTS (questionnaire)
  • Overall quality of life (questionnaire)
  • Physical measures for diagnosing joint hypermobility and instability
  • Physical screening for POTS
  • Physical screening for body awareness, balance and coordination

Objectives and Hypotheses

  1. What is the prevalence of HSD, POTS and MCAS in a 'healthy' young adult population?
  2. How often are HSD, POTS and MCAS undiagnosed in a 'healthy' young adult population?
  3. Are there factors that trigger or precede the development of widespread symptoms in people who have GJH, causing them to develop HSD?
  4. What risk factors are associated with increased likelihood that an individual will develop POTS, MCAS, or HSD?
  5. Do balance or motor control in the neck differ in asymptomatic joint hypermobility compared to symptomatic hypermobility?
  6. If coordination impairments exist in asymptomatic people with hypermobility, does that predict development of HSD?

Questionnaires will be on secure Google Forms accessed through participants' phones or other electronic devices. Participants may pause and return to the questionnaires if they choose. We intend for the questionnaires to require no more than 30 minutes to complete; we may need to eliminate questions from the current list to achieve this.

Physical measurements will be performed only at the initial data collection. These measurements will be performed by licensed physical therapists, who may be assisted by physical therapy graduate students with adequate training to assist in selected data collection. Data collection will take place in Clarkson Hall. Measurements are likely to be performed at 'stations' by various assessors, but any participant who would like to be in a private room for any or all of the assessment may request that. Physical measurements are likely to take about 30 minutes.

Each year, we will follow up by emailing participants asking them to complete questionnaires that will be a subset of the initial set of questions. Questionnaires will again be implemented through secure Google Forms.

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Leslie N Russek, PT, DPT, PhD
  • Numéro de téléphone: 315-212-2851
  • E-mail: Lrussek@clarkson.edu

Sauvegarde des contacts de l'étude

Lieux d'étude

    • New York
      • Potsdam, New York, États-Unis, 13699
        • Clarkson University, Lewis School of Health & Life Sciences
        • Contact:
        • Contact:
        • Chercheur principal:
          • Leslie Russek, PT, DPT, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Health Science graduate students are typically 20-35 years old, though some non-traditional students might be slightly older.

La description

Inclusion Criteria: Clarkson University Health Sciences students. -

Exclusion Criteria: Other physical conditions that preclude collecting >25% of physical measurements at initial data collection.

-

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
hypermobile - symptomatic
People who meet the diagnostic criteria for hEDS or HSD
non-hypermobile
People who do not meet the diagnostic criteria for generalized joint laxity, hEDS or HSD
hypermobile - non-symptomatic
People with generalized joint laxity but not meeting diagnostic criteria for hEDS/HSD

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Hypermobility status
Délai: 5 years
Subject meets diagnostic criteria for generalized joint hypermobility, hypermobile Ehlers-Danlos Syndrome or Hypermobility Spectrum Disorders. This will be nominal: None, GJH, HSD hEDS.
5 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
EuroQol, 5-Dimension, 5-Level (EQ-5D-5L)
Délai: 5 years
5-domain quality of life measure: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It scores each domain on a 1-5 scale, where higher scores indicate greater disability. The scores are not summed.
5 years
Hypermobility Spider Questionnaire
Délai: 5 years
31-item questionnaire quantifying symptoms in 8 domains: Neuromusculoskeletal, Pain, Fatigue, Gastrointestinal, Cardiac Dysautonomia, Urogenital, Anxiety, Depression. Each domain is scored 0-100, where 0 is no symptoms in that domain, and 100 is the most symptoms in that domain.
5 years

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
New comorbidities
Délai: 5 years
New presentation of POTS or MCAS
5 years
Physical activity
Délai: 5 years
Modified International Physical Activity Questionnaire short form measures vigorous, moderate, and light exercises and computes 'metabolic minutes' or METs. Minimum score of 0 indicates no exercise. The maximum possible score allowed is 19,278.
5 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

20 juin 2026

Achèvement primaire (Estimé)

20 juin 2036

Achèvement de l'étude (Estimé)

20 juin 2036

Dates d'inscription aux études

Première soumission

15 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

To ensure privacy of health information in a fairly small subject pool.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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