Cerebrovascular accident (CVA) Stroke
Conditions
Interventions
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Ischemic or haemorrhagic stroke * 6 months post-onset * Functional ambulation category (FAC)
Exclusion criteria
Exclusion criteria: * any premorbid progressive or non-progressive brain disease * use of beta blockers or any other medication that influences the heart rhythm * Pregnant women * Persons with pacemakers or any other implantable device * Brainstem infarction * Diabetes * Phatic disorders * Arrhythmias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Stress * Objective: Heart rate variability, Heart rate, Galvanic skin respons and temperature. * Subjective-momentary: Stress level score on a VAS-scale * Subjective-general: Score on the Perceived stress scale (PSS) * Subjective-ambulatory: Stress level is checked 12 times a day during the 5-days ambulatory measurement. Measured with an app. - Mental workload * Objective: Heart rate variability * Subjective-momentary: Score on the Rating Scale of Mental Effort (RSME) * Subjective-ambulatory: Mental workload is checked 12 times a day during the 5-days ambulatory measurement. Measured with an app. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Demographics and phenotype of patients, such as: date of birth, gender , level of education, marital status, profession, sports activities/hobbies, stroke type, date stroke, therapy history since stroke, medication, comorbidity (CIRS scale), - Baseline functioning * Functional Ambulation Categories (FAC) score * Berg balance Scale (BSS) score * 10 meter walk test score * Perceived stress scale (PSS) score * Attention tasks score on d2 test, Trail Making Test (TMT) and auditory stroop * Hospital Anxiety and Depression Scale (HADS) score - Performance * Number of wrong answers (Pasat test, stroop test), amount of sway, number of obstacles not avoided, walking pace - Physical behavior: *Ambulatory, objective: : Physical behavior of patients will be measured by the Activ8 system. he Activ8 distinguishes different activities and postures, namely, lying, sitting, standing, walking, cycling and running. Additionally the total energy expenditure can be determined. * Ambulatory, subjective: Subjects fill out an electronic diary about the type of activities and duration of the activities performed during the 5-day ambulatory measurement 12 times a day. | — |
Countries
The Netherlands
Outcome results
None listed