Tablet-based Aphasia Therapy in the Acute Phase After Stroke

• ClinicalTrials.gov Identifier: NCT03679637
• Recruitment Status: Completed
• First Posted: September 20, 2018
• Last Update Posted: April 9, 2020
• Sponsor: University Hospital, Ghent
• Information provided by (Responsible Party): Neurologie, University Hospital, Ghent

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Aphasia; Stroke, Acute	Behavioral: Tablet-based aphasia therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Feasibility, Usability and Acceptability of a Tablet-based Aphasia Therapy in the Acute Phase After Stroke
• Actual Study Start Date: September 28, 2018
• Actual Primary Completion Date: December 20, 2019
• Actual Study Completion Date: December 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Feasibility of a tablet-based aphasia therapy via the recruitment rate [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
   Recruitment rate: number of patients enrolled versus total patients meeting study criteria + notation of reasons why patients did not enroll
2. Feasibility of a tablet-based aphasia therapy via the retention rate [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
   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
3. Feasibility of a tablet-based aphasia therapy via the adherence rate, [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
   Adherence rate: time patients practiced versus time advised to practice + notation of reasons why patients did not practice the advised time
4. Feasibility of a tablet-based aphasia therapy via protocol deviations [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
   Notation of any protocol deviations
5. Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire, [ Time Frame: date of hospital discharge, an average of 1 week ]
   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)
6. Usability of a tablet-based aphasia therapy via an observational checklist [ Time Frame: date of hospital discharge, assessed up to 20 weeks ]
   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)
7. Usability of a tablet-based aphasia therapy via within-task improvements of the app [ Time Frame: from date of inclusion to date of hospital discharge, assessed up to 20 weeks ]
   Notation of exercises performed with the app
8. Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction [ Time Frame: date of hospital discharge, an average of 1 week ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Belgium

University Hospital, department of neurology

Gent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

• Principal Investigator: Veerle De Herdt; University Ghent

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Neurologie, Principal Investigator, clinical professor Veerle De Herdt, University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT03679637
• Other Study ID Numbers: EC/2018/1006
• First Posted: September 20, 2018
• Last Update Posted: April 9, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Aphasia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations