A. PrognosisThe first aim of this study is to gain insight in the recovery pattern of the linguistic levels (i.e. semantics, phonology and syntax) in aphasia due to stroke. Information on the frequency of the occurrence of linguistic deficits in…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A. Prognosis
The primary outcome measure is the severity of the linguistic deficits at
several time points in the first year post-stroke, measured with the ScreeLing,
a test that measures functioning on three linguistic levels: semantics,
phonology and syntax.
B. Quality of Life
The primary outcome measure concern the quality of life as measured with the
Health Utilities Index at several time points in the first year post-stroke.
Secondary outcome
A. Prognosis
The secondary outcome measures are the severity of aphasia measured with the
Token Test and the verbal communication measured with the Aphasia Severity
Rating Scale, at several time points in the first year post-stroke. In
addition, the extent of the recovery of aphasia and the performance in the
non-linguistic cognitive domains at 3 months and at one year post onset.
B. Quality of life
The secondary outcome measures are the EuroQol, the modified Rankin Scale and
the Barthel Index, which are respectively related to the quality of life and
daily life functioning, measured at several time points in the first year
post-stroke.
Background summary
The prevalence of aphasia is approximately 20-25% among all stroke patients.
Information on the rate and degree of the recovery of aphasia is very
important. Patients and family want to have insight in the disorder, prognosis
and therapeutic possibilities as soon as possible. Prognostic information is of
clinical importance too, because it may affect our choices concerning
rehabilitation facilities. There are indications that the initial severity of
the language disorder during the first week post onset predicts the outcome of
aphasia at one year after stroke. However, a detailed study of the recovery
pattern of the various linguistic levels is not available. Lesion size and
lesion location are also thought to be important factors in aphasia recovery
just as the initial stroke severity. Many studies agree that quality of life is
negatively affected by aphasia. However, there are no specific data on the
exact relationship between aphasia and quality of life.
Study objective
A. Prognosis
The first aim of this study is to gain insight in the recovery pattern of the
linguistic levels (i.e. semantics, phonology and syntax) in aphasia due to
stroke. Information on the frequency of the occurrence of linguistic deficits
in patients with aphasia and the course during recovery is lacking. The
recovery pattern of the linguistic levels has to be analyzed against the
background of co-existing cognitive disorders. The presence of cognitive
disorders is reported to interfere with functional outcome. The research
questions are:
1. What is the recovery pattern of the linguistic disorders (i.e. semantics,
phonology and syntax) in patients with aphasia due to stroke and what is the
final outcome?
2. What is the influence of the initial specific linguistic disorders on the
prognosis?
3 a. Does the rate of recovery on one or more linguistic levels predict the
outcome of linguistic functioning at one year? b. If so, which period is
crucial in predicting the outcome at one year?
4. Which factors including non-linguistic cognitive deficits, stroke severity,
lesion size and location, influence the recovery of the linguistic disorders?
B. Quality of Life
The second aim of this study is to investigate the influence of linguistic
deficits on the quality of life. The research questions are:
1. Does the quality of life evolve over time?
2. Is there an association between the recovery pattern on (one of) the
linguistic levels and the quality of life?
3. In which period during recovery, and with which linguistic levels is this
association the strongest?
4. Which factors such as linguistic and non-linguistic cognitive deficits are
associated with quality of life?
Study design
This study is an observational prospective follow-up study. Patients with
aphasia due to stroke (n=200) will be assessed from two days until one-year
post onset.
Study burden and risks
Participants will receive an evaluative assessment six times during a one-year
follow-up including language, daily life functioning and quality of life tests.
Participants will be tested at 2-6 days post-onset, at 7-14 days, at 6 weeks,
at 3 months, at 6 months and finally at one year post-onset. At 3 months and at
one-year post onset participants will also be assessed with a
neuropsychological examination. All assessments will be held on the same day as
the regular visits to the speech therapist as much as possible so that
participants don*t have to come on an extra visit. If necessary, patients will
be visited at home. Each assessment takes about one hour to complete, so the
total extra time for each participant during the one-year follow-up is about 6
hours. The assessments are not associated with any risk. All included tests are
widely used in daily practice and also in follow-up studies. The difference is
that in our study participants will be assessed at specific moments starting
from the acute phase.
Participants benefit a lot from this study, since they will gain insight in
their recovery pattern during the first year post-stroke. Cognitive disorders
that are detected will be described to the speech therapist, since they can
effect the treatment of the language disorder. As a result the speech therapy
can be adjusted so that the participant will receive the most optimal
treatment. Thus, participants are ensured of a good follow-up inspection and
also a good guidance of the patient, family and speech therapist.
Postbus 1738
3000 DR Rotterdam
Nederland
Postbus 1738
3000 DR Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Stroke patients with aphasia < six days post onset; Age 18 years or more; Language near native; Testable with the ScreeLing within six days post onset.
Exclusion criteria
Prior stroke and/or aphasia; (suspected) Dementia; Severe dysartria and/ or verbal apraxia; Developmental dyslexia; Severe perceptual, visual and/or hearing deficit; Stroke due to a subarachnoidal hemorrhage; Illiteracy; Recurrent stroke; Recent psychiatric history.
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 | NL11047.078.06 |