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NCT Number: NCT03679637

Tablet-based Aphasia Therapy in the Acute Phase After Stroke

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.

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Key information

Conditions

Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Stroke, Acute Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, department of neurology

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tablet-based aphasia therapy

Behavioral

patients will independently practice with a speech app during hospitalisation

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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

  8. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2018
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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