Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Presentation of Young Adults With and Without Joint Hypermobility

17 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

100

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Leslie N Russek, PT, DPT, PhD
  • Número de teléfono: 315-212-2851
  • Correo electrónico: Lrussek@clarkson.edu

Copia de seguridad de contactos de estudio

  • Nombre: Samantha Marocco, PT, DPT, EdD
  • Número de teléfono: 315-268-7622
  • Correo electrónico: smarocco@clarkson.edu

Ubicaciones de estudio

    • New York
      • Potsdam, New York, Estados Unidos, 13699
        • Clarkson University, Lewis School of Health & Life Sciences
        • Contacto:
          • Samantha Marocco, PT, DPT, EdD
          • Número de teléfono: 315-268-7622
          • Correo electrónico: smarocco@clarkson.edu
        • Contacto:
          • Heather Shattuck, PT, DPT
          • Número de teléfono: 315-268-3786
          • Correo electrónico: hshattuc@clarkson.edu
        • Investigador principal:
          • Leslie Russek, PT, DPT, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

Inclusion Criteria: Clarkson University Health Sciences students. -

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

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hypermobility status
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
EuroQol, 5-Dimension, 5-Level (EQ-5D-5L)
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
New comorbidities
Periodo de tiempo: 5 years
New presentation of POTS or MCAS
5 years
Physical activity
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

20 de junio de 2026

Finalización primaria (Estimado)

20 de junio de 2036

Finalización del estudio (Estimado)

20 de junio de 2036

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir