Tablet-based Aphasia Therapy in the Chronic Phase

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622411
• Other study ID #: EC/2018/0909
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: February 23, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• speech app
language exercises provided by the speech therapist in hospital + independent practice of language exercises via a tablet and speech app
• brain games
language exercises provided by the speech therapist in hospital + independent recreational tablet use via brain games

Behavioral:
• aphasia therapy
language exercises provided by the speech therapist in hospital

Locations

Country	Name	City	State
Belgium	University Hospital, department of neurology	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Naming Test (BNT)	Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty	4 months
Secondary	Spontaneous speech of the Aachen Aphasia Test (AAT)	spontaneous speech is elicited and scored during a semi-standardized interview	4 months
Secondary	Quality of life (SAQOL-39-Nl)	a questionnaire investigating the health-related quality of life of patients following stroke	4 months
Secondary	Usability questionnaire	a self-prepared 5 point-Likert Scale concerning the usability of the app	1 day