Clinical trial NCT03679637: Tablet-based Aphasia Therapy in the Acute Phase After Stroke
Official title: The Feasibility, Usability and Acceptability of a Tablet-based Aphasia Therapy in the Acute Phase After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke, Acute
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits, it is now thought that intensive aphasia therapy is effective, even in the chronic phase following stroke. However, as intensive aphasia rehabilitation is difficult to achieve in clinical practice, tablet-based aphasia therapies are explored to further facilitate language recovery. Although there is mounting evidence that computer-based treatments are effective, it is also important to assess the feasibility, usability and acceptability of these technologies, especially in the acute phase post stroke. The investigators assume that tablet-based aphasia therapy is a feasible treatment option for patients with aphasia in the acute phase following stroke. The researchers also believe that the specific app that will be used in therapy is user-friendly and that it will be well accepted by this specific patient population.

Detailed description: The study is a prospective study, with each participant undergoing testing approximately within three days after inclusion in the study (immediately prior to tablet-based aphasia therapy). Based on the results of diagnostic testing (standard of care in the acute phase), therapy will be tailored for each individual. After two short training sessions, patients will independently practice with the app during hospitalisation, guided by a user-friendly instruction sheet. Patients will be encouraged to practice as much as possible, with a minimum of 30 minutes per day. Exercises will be selected by the speech-language therapist based on diagnostic results and will be adjusted for difficulty and type of exercise during treatment based on performance rates. the aim of the study is to investigate the feasibility, usability and acceptability of a tablet-based aphasia therapy in patients with aphasia in the acute phase following stroke.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with aphasia after an ischemic or hemorrhagic stroke
* Maximum 2 weeks post-stroke
* Minimum 18 years old
* A minimum proficient language level of Dutch
* Imaging (CT or MRI) prior to inclusion
* Signed informed consent

Exclusion Criteria:

* Presence of severe psychiatric disorders and/or cognitive disorders that hinder the use of the tablet-based aphasia therapy

Primary outcomes:
measure: Feasibility of a tablet-based aphasia therapy via the recruitment rate
timeFrame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
measure: Feasibility of a tablet-based aphasia therapy via the retention rate
timeFrame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
measure: Feasibility of a tablet-based aphasia therapy via the adherence rate,
timeFrame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
measure: Feasibility of a tablet-based aphasia therapy via protocol deviations
timeFrame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
measure: Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire,
timeFrame: date of hospital discharge, an average of 1 week
measure: Usability of a tablet-based aphasia therapy via an observational checklist
timeFrame: date of hospital discharge, assessed up to 20 weeks
measure: Usability of a tablet-based aphasia therapy via within-task improvements of the app
timeFrame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks
measure: Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction
timeFrame: date of hospital discharge, an average of 1 week
Secondary outcomes:
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:
citation: De Cock E, Batens K, Feiken J, Hemelsoet D, Oostra K, De Herdt V. The feasibility, usability and acceptability of a tablet-based aphasia therapy in the acute phase following stroke. J Commun Disord. 2021 Jan-Feb;89:106070. doi: 10.1016/j.jcomdis.2020.106070. Epub 2020 Dec 29.