Tablet-based Aphasia Therapy in the Acute Phase After Stroke

Stroke, Acute Clinical Trial

Official title:

The Feasibility, Usability and Acceptability of a Tablet-based Aphasia Therapy in the Acute Phase After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679637
• Other study ID #: EC/2018/1006
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: April 2020
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Stroke
• Stroke, Acute

Intervention

Behavioral:
• Tablet-based aphasia therapy
patients will independently practice with a speech app during hospitalisation

Locations

Country	Name	City	State
Belgium	University Hospital, department of neurology	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a tablet-based aphasia therapy via the recruitment rate	Recruitment rate: number of patients enrolled versus total patients meeting study criteria + notation of reasons why patients did not enroll	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Primary	Feasibility of a tablet-based aphasia therapy via the retention rate	Retention rate: number of patients continuing to use the mobile tablet until the time of discharge + notation of reasons why patients did not continue practicing	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Primary	Feasibility of a tablet-based aphasia therapy via the adherence rate,	Adherence rate: time patients practiced versus time advised to practice + notation of reasons why patients did not practice the advised time	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Primary	Feasibility of a tablet-based aphasia therapy via protocol deviations	Notation of any protocol deviations	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Primary	Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire,	Self-prepared usability questionnaire: patients will need to fill in a 5 question survey (5-point Likert scale) measuring the usability of a tablet-based therapy. Minimum score is 1 (= totally not agree), maximum score is 5 (= totally agree)	date of hospital discharge, an average of 1 week
Primary	Usability of a tablet-based aphasia therapy via an observational checklist	Self-prepared observational checklist: patients will be observed during a therapy session. Different sub-tasks will be scored for independency on a 3-point scale. Minimum score is 1 (completely dependent), maximum score is 3 (= completely independent)	date of hospital discharge, assessed up to 20 weeks
Primary	Usability of a tablet-based aphasia therapy via within-task improvements of the app	Notation of exercises performed with the app	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Primary	Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction	Vertical visual anologue scale (VAS) for satisfaction: patients have to indicate their general level of satisfaction post-intervention on a vertical VAS-scale. Minimum score is 0 (= not satisfied), maximum score is 100 (= very satisfied)	date of hospital discharge, an average of 1 week