The current study will investigate the beneficial effects of an experimental congruent movement training (eye and hand movements), compared to a control intervention with only eye movements (visual scanning therapy). Primary objectives are changes…
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Condition
- Other condition
Synonym
Health condition
beroerte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The difference scores (post training - baseline) for the shape cancellation
task and line bisection task. Per neuropsychological task, scores will be
obtained that will indicate severity of neglect.
- Shape cancelation task: the number of omissions (contralesional, ipsilesional
side), number of perseverations, start position and the time used to finalise
the task will be computed.
- Line bisection task: the deviation from the center (mm), endpoint weightings
bias and endpoints weightings sum will be computed (McIntosh et al. 2005).
2) The difference score (post training - baseline) on the visual discrimination
task. Performance (% correct responses) will be calculated per hemifield.
3) The difference score (post training - baseline) regarding the observations
as measured with the Catherine Bergego scale. The Catherine Bergego Scale is an
observation list designed to assess the presence and severity of neglect in a
range of daily activities.
For all primary endpoints, beneficial effects after CMT will be compared to
effects after EMT. Also, all outcome measures will be compared to performance
of healthy controls and non-neglect CVA patients.
Secondary outcome
1) Virtual Reality supermarket: Performance on the number of items found on the
list, efficiency of finding items and eye movement characteristics (such as
number of saccades, number of fixations) will be computed.
2) Performance during training: Correct responses, time needed to complete
trial, number of pointing movements and eye movement characteristics (such as
number of saccades, number of fixations) will be computed.
3) Eye movement characteristics (such as saccade latencies, number of
fixations) during shape cancellation task and line bisection task will be
computed.
4) Visual exploration task: performance on the number of elements reported and
eye movement characteristics per hemifield (such as number of saccades, number
of fixations) will be computed.
For all secondary endpoints, beneficial effects after CMT will be compared to
effects after EMT. Also, all outcome measures will be compared to performance
of healthy controls and non-neglect CVA patients.
Background summary
About 30% of all stroke patients admitted in a rehabilitation centre show
unilateral visuospatial neglect (Appelros et al 2002). This disorder is
characterized by the inability to respond to sensory stimuli in the affected
hemispace, due to damage to the right hemisphere (Kerkhoff 2001). Visual
scanning therapy, a training aimed at provoking eye movements to the affected
hemifield, is often applied to attenuate neglect. Recent views on the
attentional and motor system suggest new approaches to treat neglect.
Congruence between different effectors of the motor system may produce a
powerful bias in the motor system, which can counteract pathological biases in
the attentional system. Therefore, an intervention with congruent eye and hand
movements may result in greater attenuation of neglect compared to an
intervention with single eye movements (as applied in visual scanning therapy).
Study objective
The current study will investigate the beneficial effects of an experimental
congruent movement training (eye and hand movements), compared to a control
intervention with only eye movements (visual scanning therapy). Primary
objectives are changes in performance on standard neuropsychological neglect
tasks, a visual discrimination task and severity of neglect in daily life
activities (ADL; as measured with the Catherine Bergego Scale). Secondary
objectives are to gain insight in the generalizability of potential beneficial
effects of congruent/single movement training as measured with a Virtual
Reality supermarket task and changes in eye movement characteristics and
patterns (i.e. during the training itself, the neuropsychological tasks and a
visual exploration tasks).
Study design
An explorative intervention study. Patients will be randomly assigned to one of
two groups: one group of patients will receive eye movement training (control
group); the other group will receive congruent eye and hand movement training
(experimental group). Each patient will receive 10 sessions (±30 minutes each)
of training within two weeks. Performances before and after intervention will
be compared. Also, performance will be compared to two other control control
groups who will not receive any intervention (healthy controls, n=15 and stroke
patients without neglect, n=15).
Intervention
Half of the neglect patients (n=15) will receive eye movement training (visual
scanning therapy) and the other half (n=15) will receive congruent movement
training (visual scanning therapy + congruent hand movements).
Study burden and risks
The risks of this study are negligible. The burden is medium, as the patients
are tested twice (before and after 10-sessions of 30mins training). This
research can only be performed with this patient group and the intervention may
provide direct benefits for the patients.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Intervention group (neglect patients):;* Clinical diagnosed symptomatic stroke (ischemic or intracerebral haemorrhagic lesion), first or
recurrent, if possible verified by Magnetic Resonance Imaging (MRI) and/or Computed Tomography
(CT) data
* Signs of neglect:
o asymmetry between the left and right side of the stimulus field in number of missed items of at
least 2 on a shape cancelation task, and/or
o a bias towards the left or right side of space on a line bisection task, and/or
o Catherine Bergego Scale score higher than 6.
* 18-85 years of age
* Sufficient ability to comprehend and to communicate, as observed during neuropsychological
assessment and/or neglect screening
* Sufficient motivation to participate in a daily rehabilitation treatment programme for two weeks.
* Written informed consent
Exclusion criteria
Patients who recovered from neglect between inclusion and start of the training (i.e. no signs of neglect anymore on all baseline measurements) will be excluded
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 7005 |
| CCMO | NL64626.041.18 |