Clinical trial NCT03622411: Tablet-based Aphasia Therapy in the Chronic Phase
Official title: The Effect of a Tablet-based Aphasia Therapy in the Chronic Phase After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits. There is evidence that intensive aphasia therapy is effective for language recovery, even in the chronic phase post-stroke. However, as many patients are left with residual language disorders and intensive aphasia rehabilitation is difficult to achieve, the investigators are exploring tablet-based therapies to further facilitate language recovery in a cost-effective manner.

Detailed description: This study will investigate the clinical effects of intensive tablet-based aphasia therapy as an add-on to conventional aphasia therapy (= high intensive) compared to conventional aphasia therapy (either alone, or in combination with recreational tablet use (= low intensive) in patients with aphasia following stroke, as measured by specific linguistic tests, within task improvements, functional communication and quality of life.

Furthermore, the investigators want to learn more about the recovery of specific underlying language processes via event-related potentials (ERPs). At last, the investigators aim to explore whether patients with aphasia are satisfied with a tablet-based aphasia therapy, whether the app is user-friendly and which barriers the participants might have encountered.

Eligibility criteria: Inclusion Criteria:

* diagnosed with mild-severe aphasia (token test score between 7 and 49) after a left hemispheric ischemic or hemorrhagic stroke
* inclusion starting from 6 months post-stroke
* age 18 - 85 years
* being right-handed (according to the questionnaire for handedness, Van Strien)
* mother tongue: Dutch
* imaging (CT or MRI) prior to inclusion
* signed informed consent

Exclusion Criteria:

* history of a previous stroke with persistent (\> 24 hours) language symptoms
* history of other diseases of the central nervous system, psychological disorders and (developmental) speech and/or language disorders
* serious non-linguistic, cognitive disorders (as documented in the patients' medical history)
* inability to perform tablet-based tasks (based on a short training session)
* excessive use of alcohol or drugs

Primary outcomes:
measure: Boston Naming Test (BNT)
timeFrame: 4 months
Secondary outcomes:
measure: Spontaneous speech of the Aachen Aphasia Test (AAT)
timeFrame: 4 months
measure: Quality of life (SAQOL-39-Nl)
timeFrame: 4 months
measure: Usability questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital, department of neurology
Study officials:
affiliation: University Ghent
name: Veerle De Herdt
role: PRINCIPAL_INVESTIGATOR
References: