- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Poznań, Polen, 61-545
- Department of Rehabilitation and Physiotherapy Rehabilitation,
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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
|
|
The control group
The control group was composed of 26 healthy individuals recruited from the hospital staff who did not experience stroke.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
heart rate at rest
Tidsram: baseline
|
heart rate per minute
|
baseline
|
|
heart rate at rest
Tidsram: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rate after SMWT
Tidsram: baseline
|
heart rate per minute
|
baseline
|
|
heart rate after SMWT
Tidsram: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rate after SCT
Tidsram: baseline
|
heart rate per minute
|
baseline
|
|
heart rate after SCT
Tidsram: 3 weeks
|
heart rate per minute
|
3 weeks
|
|
heart rhythm at rest
Tidsram: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm at rest
Tidsram: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
heart rhythm after SMWT
Tidsram: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm after SMWT
Tidsram: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
heart rhythm after SCT
Tidsram: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
|
heart rhythm after SCT
Tidsram: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
|
increased blood pressure at rest
Tidsram: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure at rest
Tidsram: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
increased blood pressure after SMWT
Tidsram: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure after SMWT
Tidsram: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
increased blood pressure after SCT
Tidsram: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
|
increased blood pressure after SCT
Tidsram: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
|
Distance of walk after SMWT
Tidsram: baseline
|
Distance (metres)
|
baseline
|
|
Distance of walk after SMWT
Tidsram: 3 weeks
|
Distance (metres)
|
3 weeks
|
|
Distance of walk after SCT
Tidsram: baseline
|
Distance (metres)
|
baseline
|
|
Distance of walk after SCT
Tidsram: 3 weeks
|
Distance (metres)
|
3 weeks
|
|
Steps after SMWT
Tidsram: baseline
|
Number of steps (number)
|
baseline
|
|
Steps after SMWT
Tidsram: 3 weeks
|
Number of steps (number)
|
3 weeks
|
|
Steps after SCT
Tidsram: baseline
|
Number of steps (number)
|
baseline
|
|
Steps after SCT
Tidsram: 3 weeks
|
Number of steps (number)
|
3 weeks
|
|
Velocity of walk after SMWT
Tidsram: baseline
|
Mean velocity (km/h)
|
baseline
|
|
Velocity of walk after SMWT
Tidsram: 3 weeks
|
Mean velocity (km/h)
|
3 weeks
|
|
Velocity of walk after SCT
Tidsram: baseline
|
Mean velocity (km/h)
|
baseline
|
|
Velocity of walk after SCT
Tidsram: 3 weeks
|
Mean velocity (km/h)
|
3 weeks
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Ewa Chlebuś, Clinic Rehabilitation, University of Medical Sciences in Poznań
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1/2021
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .