Tablet-based Aphasia Therapy in the Chronic Phase

NCT ID: NCT03622411

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2021-02-23

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.

Conditions

Aphasia; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aphasia therapy + speech app

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

Group Type: EXPERIMENTAL

speech app

Intervention Type: DEVICE

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

aphasia therapy

Intervention Type: BEHAVIORAL

language exercises provided by the speech therapist in hospital

aphasia therapy + brain games

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

Group Type: ACTIVE_COMPARATOR

brain games

Intervention Type: DEVICE

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

aphasia therapy

Intervention Type: BEHAVIORAL

language exercises provided by the speech therapist in hospital

aphasia therapy

3 hours per week of conventional aphasia therapy during 3 weeks

Group Type: ACTIVE_COMPARATOR

aphasia therapy

Intervention Type: BEHAVIORAL

language exercises provided by the speech therapist in hospital

Interventions

speech app

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

Intervention Type: DEVICE

brain games

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

Intervention Type: DEVICE

aphasia therapy

language exercises provided by the speech therapist in hospital

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veerle De Herdt

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

University Hospital, department of neurology

Ghent, , Belgium

Countries

Belgium

Other Identifiers

EC/2018/0909

Identifier Type: -

Identifier Source: org_study_id