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Examining Relationships Between Musculoskeletal Function Measurements of Movement Efficiency and Nervous System Function After Chronic Stroke (SOMADC-CC)

27 de julio de 2026 actualizado por: University of California, Davis

SOMADC-CC (SOMAtic Dysfunction Characterization Following Chronic Cerebrovascular Disease): Biomarker Study

Stroke remains the leading cause of severe disability, and survivors frequently have incomplete recovery. More than half of older survivors have impaired mobility which contributes to poorer quality-of-life (QoL) and suffering. The annual rate of disability compared to myocardial infarction triples, and stroke accelerates natural age-related functional decline. Somatic dysfunction (SD) is impaired function of the body framework identified by physical examination. Few studies have rigorously studied SD among stroke survivors. We recently demonstrated the reliability of a novel, more construct valid osteopathic examination methodology [called the Functional Pathology of the Musculoskeletal System (FPMSS) model] to quantify SD among asymptomatic participants and patients with acute cerebral ischemia. The preliminary findings suggest that dysfunction may develop within the first week after acute ischemic stroke (IS) and be more severe among those with paralysis compared to healthy volunteers. The precise pathophysiologic mechanism underlying SD remains unknown.

The objective of this proposal is to establish the relationship between SD severity during chronic stroke recovery and physiologic biomarkers. The central hypothesis is that SD is quantifiable, correlates with biomarkers that reflect functional status, and is associated with QoL among chronic stroke survivors. There are currently no biomarkers that correlate with SD severity after IS. Establishing valid biomarkers associated with physiologic processes that are otherwise inferred by physical examination would allow for quantification of changes in response to treatment (e.g., osteopathic manipulative treatment; OMT) aimed at restoring economical biomechanical function. Testing this hypothesis will address several fundamental gaps in knowledge about osteopathic palpatory diagnosis, physiologic processes associated with SD, and its association with survivor outcomes. Until these knowledge gaps are filled, optimal strategies to complement stroke recovery in patients with neurological disability cannot fully be determined. The project specific aims are to quantify the association between SD among chronic (>3 months) IS survivors and measured (1) energy expenditure, (2) heart rate variability (HRV), and (3) patient-reported outcome (PRO) health domains.

The proposed research is significant because it will establish a novel osteopathic approach that determines the impact of whole musculoskeletal system (MSS) health on QoL among stroke survivors living with chronic disability and correlate physiologic properties related to SD. This approach will allow us to quantify SD and show meaningful associations with autonomic function, biomechanical economy, and QoL after chronic stroke. These new metrics would then be derived in stroke patients to determine SD and physiologic thresholds for those that would benefit most from OMT in a future trial. This proposal is innovative in that it seeks to shift current research and practice paradigms by re-appraising the impact of whole musculoskeletal functional economy on patient-centered outcomes among stroke survivors. Methodologically, use of the FPMSS model represents a novel, more construct valid, diagnostic paradigm to reliably identify SD and establish an osteopathic, cross-disciplinary approach to the field of stroke research. The model examines the MSS as integrated, highlighting proportionate, not merely symmetrical, posture and motion among survivors with chronic disability. Similarly, PROs have been used to quantify health status after stroke, but have not been used to study the relationship between chronic neurologic impairment and SD. Integrating contemporary patient-centered stroke outcomes, rigorous osteopathic assessment, and analysis of physiologic processes will advance our understanding of how musculoskeletal dysfunction impacts QoL after stroke.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

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: Alan Yee, D.O.
  • Número de teléfono: 916-734-3588
  • Correo electrónico: ahyee@ucdavis.edu

Ubicaciones de estudio

    • California
      • Sacramento, California, Estados Unidos, 95817
        • Reclutamiento
        • University of California Davis
        • Contacto:

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
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Consecutive outpatient ischemic stroke patients seen at the UC Davis Stroke Center.

Descripción

Inclusion Criteria:

  • • UC Davis Stroke Clinic outpatient patients >3 months from previous stroke

    • Adults ≥18 years
    • Previous admission diagnosis or referral indication:

      o Ischemic stroke (prior history of)

    • Able to sit upright, lie supine, and lie lateral recumbent left/right positions
    • Must be able to walk independently with/without walking aids.
    • Participants must have the capacity to consent to study participation themselves or have a Legally Authorized Representative (LAR) available.
    • Willingness to receive SMS (text) messages and/or email to complete REDCap QoL survey

Exclusion Criteria:

  • • Acute skeletal fracture or known dislocation; history of pathologic (osteoporotic or neoplastic) skeletal fracture of thoracic cage, hip/pelvis/sacrum, or vertebral column

    • Spinal column support brace (e.g. cervical collar)
    • History of spinal cord injury with residual neuromuscular or sensory disability
    • Clinical condition that would interfere with execution of movement or palpatory diagnostic testing, e.g. prohibitive chronic pain
    • Participants who have received either OMT or chiropractic manipulation following their stroke and prior to enrollment.

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
Ambulatory post-ischemic stroke patients (> 3 months after stroke)

Adult patients who have a history of ischemic stroke more than 3 months prior to study enrollment are eligible. Ambulatory patients seen at the UC Davis Stroke Center will be screened for eligibility.

Participants must be have the ability to sit upright, lie supine, and lie lateral recumbent to undergo musculoskeletal examination.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6 Minute Walk Test
Periodo de tiempo: 6 minute duration to be performed a single time.
Participants will walk for 6 consecutive minutes, be allowed to rest and wear support devices as needed, and have their heart rate and waling speed quantified.
6 minute duration to be performed a single time.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Somatic dysfunction
Periodo de tiempo: 15-25 minutes, single instance
participants will undergo osteopathic musculoskeletal examination based on applying Functional Pathology of the Musculoskeletal System (FPMSS) criteria to quantify somatic dysfunction --defined as proportionate loss of range of motion during passive testing
15-25 minutes, single instance
Physiologic Cost Index
Periodo de tiempo: 6 minute duration of walking, single instance
Quantify energy expense of ambulation among chronic stroke survivors
6 minute duration of walking, single instance
Heart Rate Variability
Periodo de tiempo: 5 minutes, single instance
Examine resting heart rate variability among chronic stroke survivors
5 minutes, single instance

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Alan Yee, D.O., University of California, Davis

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.

Enlaces Útiles

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)

1 de julio de 2026

Finalización primaria (Estimado)

30 de junio de 2028

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

27 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de julio de 2026

Publicado por primera vez (Actual)

30 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de julio de 2026

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

27 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2374498-1
  • 26151929 (Otro número de subvención/financiamiento: American Osteopathic Association)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .