Tablet-based Aphasia Therapy in the Chronic Phase

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Aphasia
• Intervention / Treatment: Device: speech app; Behavioral: aphasia therapy; Device: brain games

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • University Hospital, department of neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: speech app; language exercises provided by the speech therapist in hospital + independent practice of language exercises via a tablet and speech app; Behavioral: aphasia therapy; language exercises provided by the speech therapist in hospital
Active Comparator: 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)	Behavioral: aphasia therapy; language exercises provided by the speech therapist in hospital; Device: brain games; language exercises provided by the speech therapist in hospital + independent recreational tablet use via brain games
Active Comparator: aphasia therapy; 3 hours per week of conventional aphasia therapy during 3 weeks	Behavioral: aphasia therapy; language exercises provided by the speech therapist in hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Naming Test (BNT)	Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous speech of the Aachen Aphasia Test (AAT)	spontaneous speech is elicited and scored during a semi-standardized interview	4 months
Quality of life (SAQOL-39-Nl)	a questionnaire investigating the health-related quality of life of patients following stroke	4 months
Usability questionnaire	a self-prepared 5 point-Likert Scale concerning the usability of the app	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Veerle De Herdt, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): February 23, 2021
• Study Completion (Actual): February 23, 2021

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: EC/2018/0909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No