- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04821518
The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
The Use of Samsung Health and ECG M-Trace Base II Applications for the Assessment of Exercise Tolerance as the Secondary Prevention in Patients After Brain Stroke
Aperçu de l'étude
Statut
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Poznań, Pologne, 61-545
- Department of Rehabilitation and Physiotherapy Rehabilitation,
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study group (post-stroke) consisted of 26 patients (mean age 54.9±7.1) in whom ischaemic stroke occurred within 14 days before the admission to the Clinical Department.
The control group was composed of 26 healthy (mean age 55.6±6.1) individuals recruited from the hospital staff who did not experience stroke.
La description
Inclusion criteria to the post-stroke group were as follows :
- occurrence of hemiparesis after the first episode of ischaemic stroke
- stroke confirmed in the diagnostic imaging records
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score above 15 in Barthel's scale of performance in activities of daily living
- score below 12 in the National Institutes of Health Stroke Scale (NIHSS)
- available complete medical records concerning the assessed risk factors of recurrent CVD event
- lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma
Exclusion criteria from the post-stroke group were as follows:
- hemiparesis or tetraparesis following many episodes of stroke,
- lack of diagnostic imaging scans confirming the occurrence of stroke
- hospital stay at the Department of Neurological Rehabilitation for more than 14 days from the occurrence of stroke
- incomplete medical records concerning the assessed risk factors of recurrent CVD event
- score >3 on Lovett's scale of muscle strength in the paretic limbs
- score below 14 in Barthel's scale of performance in activities of daily living
- score above 13 in the NIHSS scale
- occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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The study group (post-stroke)
The study group consisted of 26 patients in whom ischaemic brain stroke occurred within 14 days before the admission to the Clinical Department, and were hospitalised at the Department of Neurological Rehabilitation of the Clinical Department of Rehabilitation in the Wiktor Dega Orthopaedic and Rehabilitation Clinical Hospital in Poznań
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The control group
The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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heart rate at rest
Délai: baseline
|
heart rate per minute
|
baseline
|
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heart rate at rest
Délai: 3 weeks
|
heart rate per minute
|
3 weeks
|
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heart rate after SMWT
Délai: baseline
|
heart rate per minute
|
baseline
|
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heart rate after SMWT
Délai: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rate after SCT
Délai: baseline
|
heart rate per minute
|
baseline
|
|
heart rate after SCT
Délai: 3 weeks
|
heart rate per minute
|
3 weeks
|
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heart rhythm at rest
Délai: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
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heart rhythm at rest
Délai: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
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heart rhythm after SMWT
Délai: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm after SMWT
Délai: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
heart rhythm after SCT
Délai: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
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heart rhythm after SCT
Délai: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
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increased blood pressure at rest
Délai: baseline
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blood pressure value [mm/Hg]
|
baseline
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increased blood pressure at rest
Délai: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
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increased blood pressure after SMWT
Délai: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
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increased blood pressure after SMWT
Délai: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
increased blood pressure after SCT
Délai: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure after SCT
Délai: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
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Distance of walk after SMWT
Délai: baseline
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Distance (metres)
|
baseline
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Distance of walk after SMWT
Délai: 3 weeks
|
Distance (metres)
|
3 weeks
|
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Distance of walk after SCT
Délai: baseline
|
Distance (metres)
|
baseline
|
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Distance of walk after SCT
Délai: 3 weeks
|
Distance (metres)
|
3 weeks
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Steps after SMWT
Délai: baseline
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Number of steps (number)
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baseline
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Steps after SMWT
Délai: 3 weeks
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Number of steps (number)
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3 weeks
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Steps after SCT
Délai: baseline
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Number of steps (number)
|
baseline
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Steps after SCT
Délai: 3 weeks
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Number of steps (number)
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3 weeks
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Velocity of walk after SMWT
Délai: baseline
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Mean velocity (km/h)
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baseline
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Velocity of walk after SMWT
Délai: 3 weeks
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Mean velocity (km/h)
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3 weeks
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Velocity of walk after SCT
Délai: baseline
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Mean velocity (km/h)
|
baseline
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Velocity of walk after SCT
Délai: 3 weeks
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Mean velocity (km/h)
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3 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ewa Chlebuś, Clinic Rehabilitation, University of Medical Sciences in Poznań
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1/2021
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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