Tablet-based Aphasia Therapy in the Acute Phase After Stroke

The Feasibility, Usability and Acceptability of a Tablet-based Aphasia Therapy in the Acute Phase After Stroke

As aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits, it is now thought that intensive aphasia therapy is effective, even in the chronic phase following stroke. However, as intensive aphasia rehabilitation is difficult to achieve in clinical practice, tablet-based aphasia therapies are explored to further facilitate language recovery. Although there is mounting evidence that computer-based treatments are effective, it is also important to assess the feasibility, usability and acceptability of these technologies, especially in the acute phase post stroke. The investigators assume that tablet-based aphasia therapy is a feasible treatment option for patients with aphasia in the acute phase following stroke. The researchers also believe that the specific app that will be used in therapy is user-friendly and that it will be well accepted by this specific patient population.

Study Overview

• Status: Completed
• Conditions: Aphasia; Stroke, Acute
• Intervention / Treatment: Behavioral: Tablet-based aphasia therapy

Detailed Description

The study is a prospective study, with each participant undergoing testing approximately within three days after inclusion in the study (immediately prior to tablet-based aphasia therapy). Based on the results of diagnostic testing (standard of care in the acute phase), therapy will be tailored for each individual. After two short training sessions, patients will independently practice with the app during hospitalisation, guided by a user-friendly instruction sheet. Patients will be encouraged to practice as much as possible, with a minimum of 30 minutes per day. Exercises will be selected by the speech-language therapist based on diagnostic results and will be adjusted for difficulty and type of exercise during treatment based on performance rates. the aim of the study is to investigate the feasibility, usability and acceptability of a tablet-based aphasia therapy in patients with aphasia in the acute phase following stroke.

• Study Type: Interventional
• Enrollment (Actual): 25
• 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with aphasia after an ischemic or hemorrhagic stroke
• Maximum 2 weeks post-stroke
• Minimum 18 years old
• A minimum proficient language level of Dutch
• Imaging (CT or MRI) prior to inclusion
• Signed informed consent

Exclusion Criteria:

• Presence of severe psychiatric disorders and/or cognitive disorders that hinder the use of the tablet-based aphasia therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Each participant will receive a tablet-based aphasia therapy	Behavioral: Tablet-based aphasia therapy; patients will independently practice with a speech app during hospitalisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of a tablet-based aphasia therapy via the recruitment rate	Recruitment rate: number of patients enrolled versus total patients meeting study criteria + notation of reasons why patients did not enroll	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Feasibility of a tablet-based aphasia therapy via the retention rate	Retention rate: number of patients continuing to use the mobile tablet until the time of discharge + notation of reasons why patients did not continue practicing	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Feasibility of a tablet-based aphasia therapy via the adherence rate,	Adherence rate: time patients practiced versus time advised to practice + notation of reasons why patients did not practice the advised time	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Feasibility of a tablet-based aphasia therapy via protocol deviations	Notation of any protocol deviations	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire,	Self-prepared usability questionnaire: patients will need to fill in a 5 question survey (5-point Likert scale) measuring the usability of a tablet-based therapy. Minimum score is 1 (= totally not agree), maximum score is 5 (= totally agree)	date of hospital discharge, an average of 1 week
Usability of a tablet-based aphasia therapy via an observational checklist	Self-prepared observational checklist: patients will be observed during a therapy session. Different sub-tasks will be scored for independency on a 3-point scale. Minimum score is 1 (completely dependent), maximum score is 3 (= completely independent)	date of hospital discharge, assessed up to 20 weeks
Usability of a tablet-based aphasia therapy via within-task improvements of the app	Notation of exercises performed with the app	from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction	Vertical visual anologue scale (VAS) for satisfaction: patients have to indicate their general level of satisfaction post-intervention on a vertical VAS-scale. Minimum score is 0 (= not satisfied), maximum score is 100 (= very satisfied)	date of hospital discharge, an average of 1 week

Collaborators and Investigators

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

Publications and helpful links

General Publications

• De Cock E, Batens K, Feiken J, Hemelsoet D, Oostra K, De Herdt V. The feasibility, usability and acceptability of a tablet-based aphasia therapy in the acute phase following stroke. J Commun Disord. 2021 Jan-Feb;89:106070. doi: 10.1016/j.jcomdis.2020.106070. Epub 2020 Dec 29.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: EC/2018/1006

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