The main aim of this proof-of-principle project is to explore whether 1) standardized conditions (physical tasks, cognitive tasks and a combination of both) differing in task difficulty are associated with distinct physiological responses…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
- 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.
Background summary
Nowadays, progress in the stroke rehabilitation process is measured by
performance. However, how demanding a performance or a task is in terms of
mental workload (the costs) and stress associated with the performance remains
unclear. Measuring mental workload and stress objectively during the
rehabilitation process might be a valuable instrument to monitor progress in
the rehabilitation trajectory. So far, objective representations of mental
workload and stress have not been studied in this population.
Study objective
The main aim of this proof-of-principle project is to explore whether 1)
standardized conditions (physical tasks, cognitive tasks and a combination of
both) differing in task difficulty are associated with distinct physiological
responses representative for mental workload and/or stress, and 2) whether
results of the standardized measurements can be extrapolated to measurements in
daily life conditions.
Study design
Subjects will perform a protocol of standardized motor (standing, walking) and
cognitive tasks and a combination of cognitive and motor tasks, differing in
motor and/or cognitive task difficulty. During/after each task performance,
mental workload and stress will be measured both objectively and with
questionnaires. Prior to the standardized lab measurements the subjects will
have an intake, where we do some physical and cognitive tests. Additionally to
the standardized lab measurement there will also be done a 5-day ambulatory
measurement.
Intake:
The following tests will be done during the intake
* Functional Ambulation Categories (FAC)
* Berg Balance Scale (BBS)
* 10 meter walk (10MW) test
* Hospital Anxiety and Depression Scale (HADS)
* Perceived Stress Scale (PSS)
* Determining FAC level
* Attention tests, d2 and Trial making Test (TMT)
Standardized Lab measurement:
Executing three sets of tasks, consisting of all three tasks (within a set,
increasing difficulty level). All tasks take 3 minutes, 2 minutes rest in
between the tasks and 15 minutes rest between the task sets.
* Seated tasks (1. sitting, 2. sitting + PASAT test, 3. sitting + PASAT test).
* Standing tasks (1. standing, 2. Standing with eyes closed, 3. standing with
eyes closed + auditory stroop task)
* Walking tasks (1. walking, 2. walking + obstacle avoidance task, 3. walking +
obstacle avoidance task + auditory stroop task)
Questionnaires after each task, RMSE and VAS scale for momentary stress
Ambulatory measurements:
Subjects wear the devices, IMEC chest patch, IMEC chill band and Activ8 for 5
consecutive days. Every day, twelve times a day stress, mental workload level
and activity will be monitored via an app.
Study burden and risks
Our inclusion criteria and consent procedure warrant the capacity of the
subjects. The study will not directly benefit the participating subjects and is
non-therapeutic in nature. However, this study will add to the accuracy of
detection mental workload and stress in patients with stroke and will give us
more insight in how demanding tasks are during a rehabilitation program.
Ultimately, the study results will give us the opportunity to optimize the
design of rehabilitation program on a personal basis in order to achieve the
best result. Since all measurements are non-invasive and all tasks are
minimally physically demanding, the risk of participation is minimal. The
maximum duration of the test session is 2,5 hours and frequent breaks are
provided.
The risk of wearing the measurement equipment is similar to the risk
when wearing a commercial fitness tracker e.g. fitbit. The main risk is the
development of skin irritations due to the chest patch. The CE marked patch
however is designed by Delta to be biocompatible for measurements up to 7 days.
The participants will be explicitly told that when they experience any
irritations they can contact the experimenter and take off the patch. The
medical doctor involved in this study, is aware of this risk and is also
available for consults. Further measurements with both sensors are done in a
safe, non-invasive manner. However, to exclude any risk, people with implanted
devices such as a pacemaker or pregnant women are excluded from the study.
We strongly believe that the potential benefits from this research for
future stroke patients outweigh the minimal patient burden.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
* Ischemic or haemorrhagic stroke * 6 months post-onset
* Functional ambulation category (FAC) <= 3/4/5
* age * 18 years
* Sufficient comprehension of the Dutch language
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL59099.078.16 |