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Clinical Trials/NCT03679637
NCT03679637
Completed
Not Applicable

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

University Hospital, Ghent1 site in 1 country25 target enrollmentSeptember 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aphasia
Sponsor
University Hospital, Ghent
Enrollment
25
Locations
1
Primary Endpoint
Feasibility of a tablet-based aphasia therapy via the recruitment rate
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2018
End Date
December 20, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neurologie

Principal Investigator, clinical professor Veerle De Herdt

University Hospital, Ghent

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

Outcomes

Primary Outcomes

Feasibility of a tablet-based aphasia therapy via the recruitment rate

Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks

Recruitment rate: number of patients enrolled versus total patients meeting study criteria + notation of reasons why patients did not enroll

Feasibility of a tablet-based aphasia therapy via the retention rate

Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks

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

Feasibility of a tablet-based aphasia therapy via the adherence rate,

Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks

Adherence rate: time patients practiced versus time advised to practice + notation of reasons why patients did not practice the advised time

Feasibility of a tablet-based aphasia therapy via protocol deviations

Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks

Notation of any protocol deviations

Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire,

Time Frame: date of hospital discharge, an average of 1 week

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)

Usability of a tablet-based aphasia therapy via an observational checklist

Time Frame: date of hospital discharge, assessed up to 20 weeks

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)

Usability of a tablet-based aphasia therapy via within-task improvements of the app

Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks

Notation of exercises performed with the app

Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction

Time Frame: date of hospital discharge, an average of 1 week

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)

Study Sites (1)

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