In this study the effectiveness of online cognitive flexibility training on cognitive functioning in stroke patients will be investigated. The aim of this study is to improve executive functions: both trained executive functions as well as untrained…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is executive functioning as measured by several
neuropsychological tasks (Fluency, Tower of London, Trail Making Test,
letter-number sequencing)
See protocol for a description of these tasks.
Secondary outcome
1) Cognitive flexibility as measured by switchcost (reactietimes op
switchtrials compared to reaction times on non -switchtrials) on the switch
task.
2) Cognitive functioning as measured by several neuropsychological tasks and
computer tasks (see protocol)
3) Training improvement
4) Subjective cognitive functioning and functioning in daily life as measured
by: dysexecutive questionnaire (DEX), Cognitive Failure Questionnaire (CFQ),
Utrechtse Schaal voor Evaluatie en Revalidatie- Participatie (USER-P),
Instrumental activity of daily life scale (IADL), en Short Form Health Survey
(SF-36)
5) Imaging analyses (resting state fMRI, Diffusion Tensor Imaging, Voxel Based
Morphometry)
Background summary
Stroke frequently results in executive dysfunctions even in the chronic phase.
Executive functions are very important for everyday life activities. Therefore,
there is a great need for improved cognitive rehabilitation in stroke patients.
One promising way to ameliorate cognitive impairments after stroke is to use
computer games as cognitive exercises. A recent review by our group indicates
that *brain training* in elderly is beneficial if the training emphasizes
cognitive flexibility. Therefore, we hypothesize that it is highly likely that
cognitive flexibility training will also result in cognitive improvements in
stroke patients. Furthermore, in several studies, changes in brain activity
have been observed after intensive cognitive training which relate to improved
cognitive functioning. Against this background, we planned the *Training
Project Amsterdam Seniors and Stroke* (TAPASS) study.
Study objective
In this study the effectiveness of online cognitive flexibility training on
cognitive functioning in stroke patients will be investigated. The aim of this
study is to improve executive functions: both trained executive functions as
well as untrained executive functions. Moreover, we expect that these
functions also improve in everyday life and generalize to other cognitive
functions which will improve quality of life. The current study furthermore
examines the relationship between changes in cognitive functioning and neuronal
alterations. The results of this study can be helpful for development of
treatments that assist the recovery of people suffering from stroke.
Study design
This study is a multicenter, double blind, randomized, controlled intervention
study with an active and a waiting list control group. The patient (post-acute
and chronic) will be randomized over three conditions (cognitive flexibility
training, active mock training, and waiting list). The groups will be compared
directly before training (T=0), after 6 weeks of training (T=1), directly after
(T=2) and 4 weeks after training (T=3). The waiting list control group will be
assessed during their waiting list period of 12 weeks, at the same time-points
as the training groups. Furthermore, patients will be compared with healthy
elderly who had the same training (this latter group is from a different study
and will thus not be part of the current protocol).
Intervention
Participants will be randomized over three conditions: online cognitive
flexibility training, online mock training (active control), or waiting list.
The training duration is 12 weeks during which participants will train five
times per week for 30 minutes per session. The computer tasks for both
conditions have been developed to be visually attractive and motivating.
Furthermore, participants will receive direct feedback over their performance
during training. The cognitive flexibility training includes tasks that train
attention, reasoning, and working memory. The participants will frequently
switch between these tasks to assure that cognitive flexibility is needed. The
mock training consists of computer tasks that do not train cognitive
functioning and will not switch frequently between these tasks to assure that
cognitive flexibility is not required. The waiting list group will get access
to the cognitive flexibility training after their waiting list period of 12
weeks.
Study burden and risks
All participants will have to train at home during at least 30 minutes per day,
five days per week for 12 weeks. Furthermore, participants will be assessed
several times. In total, including training, participants will spend
approximately 50 hours on this study (54 hours for the waiting list group). We
expect that participants will not find the training burdensome because it is
designed to be interesting and challenging. Participants who participate in the
MRI part of the study will be scanned twice for one hour. To our knowledge
there are no risks involved in participating in this study. Difference in
benefit is expected between the training and the active control condition. So
far none of the treatments has been proven to be superior to the other.
Moreover, after the study period, both groups will be offered the opportunity
to train with the tasks used in the intervention group.
It is expected that intensive computer based cognitive flexibility training
will result in improvement of executive functioning. Patients may benefit from
this in their everyday life activities. Furthermore, results of this study can
be helpful for development of treatments that assist the recovery of people
suffering from stroke.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
1) Suffered from stroke and referred to rehabilitation; 2) Presence of cognitive dysfunction due to stroke; 3) Age between 30 and 80 years; 4) Daily access to computer with internet connection and able to use mouse; 5) lnformed consent for study participation.
Exclusion criteria
1) Any disease other than stroke which results in severe cognitive impairments 2) Severe psychological, psychiatric, or somatic comorbidity which could strongly influence the performance on the neuropsychological assessment and training possibilities 3) Mentally (Telephone Interview Cognitive Status (TICS) score < 26) and physically (medically unstable) not fit enough to complete training protocol. 4) Aphasia, neglect, paresis or paralysis of the preferred hand, colorblindness, invalidating vision or hearing problems, or severe computer fear disabling the participants to fully complete the neuropsychological assessment and training
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 |
|---|---|
| CCMO | NL44685.029.13 |
| OMON | NL-OMON22908 |