- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Poznań, Polen, 61-545
- Department of Rehabilitation and Physiotherapy Rehabilitation,
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
heart rate at rest
Tidsramme: baseline
|
heart rate per minute
|
baseline
|
heart rate at rest
Tidsramme: 3 weeks
|
heart rate per minute
|
3 weeks
|
heart rate after SMWT
Tidsramme: baseline
|
heart rate per minute
|
baseline
|
heart rate after SMWT
Tidsramme: 3 weeks
|
heart rate per minute
|
3 weeks
|
heart rate after SCT
Tidsramme: baseline
|
heart rate per minute
|
baseline
|
heart rate after SCT
Tidsramme: 3 weeks
|
heart rate per minute
|
3 weeks
|
heart rhythm at rest
Tidsramme: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
heart rhythm at rest
Tidsramme: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
heart rhythm after SMWT
Tidsramme: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
heart rhythm after SMWT
Tidsramme: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
heart rhythm after SCT
Tidsramme: baseline
|
heart rhythm interpreting ECG (regular or irregular)
|
baseline
|
heart rhythm after SCT
Tidsramme: 3 weeks
|
heart rhythm interpreting ECG (regular or irregular)
|
3 weeks
|
increased blood pressure at rest
Tidsramme: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
increased blood pressure at rest
Tidsramme: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
increased blood pressure after SMWT
Tidsramme: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
increased blood pressure after SMWT
Tidsramme: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
increased blood pressure after SCT
Tidsramme: baseline
|
blood pressure value [mm/Hg]
|
baseline
|
increased blood pressure after SCT
Tidsramme: 3 weeks
|
blood pressure value [mm/Hg]
|
3 weeks
|
Distance of walk after SMWT
Tidsramme: baseline
|
Distance (metres)
|
baseline
|
Distance of walk after SMWT
Tidsramme: 3 weeks
|
Distance (metres)
|
3 weeks
|
Distance of walk after SCT
Tidsramme: baseline
|
Distance (metres)
|
baseline
|
Distance of walk after SCT
Tidsramme: 3 weeks
|
Distance (metres)
|
3 weeks
|
Steps after SMWT
Tidsramme: baseline
|
Number of steps (number)
|
baseline
|
Steps after SMWT
Tidsramme: 3 weeks
|
Number of steps (number)
|
3 weeks
|
Steps after SCT
Tidsramme: baseline
|
Number of steps (number)
|
baseline
|
Steps after SCT
Tidsramme: 3 weeks
|
Number of steps (number)
|
3 weeks
|
Velocity of walk after SMWT
Tidsramme: baseline
|
Mean velocity (km/h)
|
baseline
|
Velocity of walk after SMWT
Tidsramme: 3 weeks
|
Mean velocity (km/h)
|
3 weeks
|
Velocity of walk after SCT
Tidsramme: baseline
|
Mean velocity (km/h)
|
baseline
|
Velocity of walk after SCT
Tidsramme: 3 weeks
|
Mean velocity (km/h)
|
3 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ewa Chlebuś, Clinic Rehabilitation, University of Medical Sciences in Poznań
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1/2021
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