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Completed

NCT Number: NCT03622411

Tablet-based Aphasia Therapy in the Chronic Phase

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.

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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 Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, department of neurology

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

speech app

Device

language exercises provided by the speech therapist in hospital + independent practice of language exercises via a tablet and speech app

brain games

Device

language exercises provided by the speech therapist in hospital + independent recreational tablet use via brain games

aphasia therapy

Behavioral

language exercises provided by the speech therapist in hospital

Primary outcomes

  1. Boston Naming Test (BNT)

    Time frame: 4 months

    Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty

Secondary outcomes

  1. Spontaneous speech of the Aachen Aphasia Test (AAT)

    Time frame: 4 months

    spontaneous speech is elicited and scored during a semi-standardized interview

  2. Quality of life (SAQOL-39-Nl)

    Time frame: 4 months

    a questionnaire investigating the health-related quality of life of patients following stroke

  3. Usability questionnaire

    Time frame: 1 day

    a self-prepared 5 point-Likert Scale concerning the usability of the app

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

The Effect of a Tablet-based Aphasia Therapy in the Chronic Phase After Stroke

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2018
Registry last updated
Jan 10, 2023

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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