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

27 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

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

Lieux d'étude

    • California
      • Sacramento, California, États-Unis, 95817
        • Recrutement
        • University of California Davis
        • Contact:

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
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 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
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
6 Minute Walk Test
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Somatic dysfunction
Délai: 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
Délai: 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
Délai: 5 minutes, single instance
Examine resting heart rate variability among chronic stroke survivors
5 minutes, single instance

Collaborateurs et enquêteurs

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

Les enquêteurs

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

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.

Liens utiles

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)

1 juillet 2026

Achèvement primaire (Estimé)

30 juin 2028

Achèvement de l'étude (Estimé)

30 juin 2028

Dates d'inscription aux études

Première soumission

27 juillet 2026

Première soumission répondant aux critères de contrôle qualité

27 juillet 2026

Première publication (Réel)

30 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 juillet 2026

Dernière vérification

1 juillet 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

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

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