We study training effects in patients that receive training in the early CVA-phase (CVA < 6 weeks).Goals:1. Determination of the training effects in the early phase of stroke. 2. Determination of quality of life in trained CVA patients with…
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Brief title
Condition
- Other condition
Synonym
Health condition
beroerte
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Within a single patient we can make use of multiple parameters to evaluate if
and how training leads to changes in visual behavior and in aspects of quality
of life:
(1) perimetry
(2) reading speed
(3) driving + oculomotor behavior.
(4) Goal Attainment Scaling (the degree to which personal goals are achieved)
(5) Quality of life questionnaires, participation scale
Secondary outcome
not applicable
Background summary
Modern society puts a strong demand on human visual capacities. Visual field
defects, especially hemianopia, therefore have far-reaching consequences for
daily life activities of a patient with hemianopia: reading is troublesome or
impossible; driving a car is usually prohibited; retaining a job can be
problematic and way-finding may be difficult. Also less complex visual tasks,
such as detecting and avoiding obstacles, watching TV etc are often disturbed
or impossible to carry out. The ultimate goal of training is a decrease in
defect size, to such extent that dependence on family, friends and society
decreases. Unfortunately, training doesn't yield the same benefits for all
patients. Earlier research points to the existence of a threshold in defect
reduction, above which significant transfer to non-trained visual tasks can be
observed: the regained visual capabilities can become generally deployable,
only when defect reduction is sufficiently large. This concerns roughly
one-third of all patients with partial cerebral blindness. This amount may
increase if training is applied sooner after the CVA.
We study to what degree defect reduction concurs with diminishing of
impairments in daily life by identifying personal, realistic training goals, in
deliberation with the patient ("Goal Attainment Scaling" or GAS). The training
-if it appears demonstrably effective- can instantly be implemented in
rehabilitation centers and -departments. Appointments concerning implementation
have been made with RC "De Hoogstraat".
Study objective
We study training effects in patients that receive training in the early
CVA-phase (CVA < 6 weeks).
Goals:
1. Determination of the training effects in the early phase of stroke.
2. Determination of quality of life in trained CVA patients with visual field
defects. Training leads to defect reduction in about 80% of the cases, both in
size and severity. Our previous studies with chronic patient groups point to
improvements in visual and visually guided tasks if and when defect reduction
reaches or surpasses a threshold.
3. Our design -in which patients are a perfect match to themselves- will bring
the study to an optimal level of 'evidence-based research'. Placebo-controlled
clinical trials are impossible using our kind of training, because the patient
needs to make a single eye movement only to find out whether a sham-training or
a real training is offered.
Study design
Training consists of repetitive detection of eccentricity-scaled stimuli that
are presented in the border area between defect and intact visual field. We
record subjective and objective measures of visual performance before and after
a period of training (T) AND before and after a period of non-training (NT).
The study-design varies the factor 'training order' (T-NT or NT-T). This design
provides answers about the training effect (T), compared to spontaneous
recovery (NT).
Patients are trained in 1 quadrant of the defect, while the other quadrant is
left untrained. In a 2nd period this is reversed. This means that in each
patient, one quadrant receives the T-NT training order and the other quadrant
receives the NT-T training order. These orders are assigned randomly to
quadrants.
This training paradigm has been designed to distinguish between spontaneous
recovery and training effects.
Intervention
Patients carry out training at home at least for 1 hour each day, at least 5
days per week. During training, 'perimetry stimuli' are presented. The stimuli
consist of short lasting light dots that are presented against a dark
background in a standardized lighting environment (height: 0.6m, width: 0.6m,
depth: 0.3m). The patient fixates the gaze on a central fixation ring and
estimates whether a presented light dot is shifted clockwise (CW) or
counter-clockwise (CCW) with respect to a reference line that runs from the
fixation dot to the edge of the screen.
We provide for a computer that draws the stimuli, and for a fixation monitoring
system using a camera that checks the patients' central eye fixation. In this
way we can avoid that patients inadvertently disturb the training by making
saccades.
Study burden and risks
The training is intensive, but appeared to be practicable in about 50 patients
so far. The neurologists that screen patients during the early CVA-phase are
asked to estimate whether the patient is likely to be able to perform the
training.
The evaluation methods (perimetry, questionnaires and driving test) are not
intensive and take up little time (about 30 minutes per measurement).
Geert Grooteplein Noord 21
Nijmegen 6525 EZ
NL
Geert Grooteplein Noord 21
Nijmegen 6525 EZ
NL
Listed location countries
Age
Inclusion criteria
isolated hemianopia as a consequence of CVA (neurological screening);
all patients: age 18-75 years; signed informed consent; stroke in early phase (< 6 weeks) at start training.
Exclusion criteria
visual neglect (tested if suspected); Macular sparing <=2°
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 | NL42031.091.13 |