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Clinical Trials/NCT03622411
NCT03622411CompletedNot Applicable

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

University Hospital, Ghent1 site in 1 country15 target enrollmentStarted: September 7, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Boston Naming Test (BNT)

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

aphasia therapy + speech app

Experimental

3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks independent practice via the speech app

Intervention: speech app (Device)

aphasia therapy + speech app

Experimental

3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks independent practice via the speech app

Intervention: aphasia therapy (Behavioral)

aphasia therapy + brain games

Active Comparator

3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks of recreational tables use (brain games)

Intervention: brain games (Device)

aphasia therapy + brain games

Active Comparator

3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks of recreational tables use (brain games)

Intervention: aphasia therapy (Behavioral)

aphasia therapy

Active Comparator

3 hours per week of conventional aphasia therapy during 3 weeks

Intervention: aphasia therapy (Behavioral)

Outcomes

Primary Outcomes

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

  • Usability questionnaire(1 day)
  • Quality of life (SAQOL-39-Nl)(4 months)
  • Spontaneous speech of the Aachen Aphasia Test (AAT)(4 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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