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Tablet-based Aphasia Therapy in the Acute Phase After Stroke

Primary Purpose

Aphasia, Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Tablet-based aphasia therapy
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, department of neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Each participant will receive a tablet-based aphasia therapy

Outcomes

Primary Outcome Measures

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
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
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
Feasibility of a tablet-based aphasia therapy via protocol deviations
Notation of any protocol deviations
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)
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)
Usability of a tablet-based aphasia therapy via within-task improvements of the app
Notation of exercises performed with the app
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)

Secondary Outcome Measures

Full Information

First Posted
September 7, 2018
Last Updated
April 8, 2020
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03679637
Brief Title
Tablet-based Aphasia Therapy in the Acute Phase After Stroke
Official Title
The Feasibility, Usability and Acceptability of a Tablet-based Aphasia Therapy in the Acute Phase After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Each participant will receive a tablet-based aphasia therapy
Intervention Type
Behavioral
Intervention Name(s)
Tablet-based aphasia therapy
Intervention Description
patients will independently practice with a speech app during hospitalisation
Primary Outcome Measure Information:
Title
Feasibility of a tablet-based aphasia therapy via the recruitment rate
Description
Recruitment rate: number of patients enrolled versus total patients meeting study criteria + notation of reasons why patients did not enroll
Time Frame
from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Title
Feasibility of a tablet-based aphasia therapy via the retention rate
Description
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
Time Frame
from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Title
Feasibility of a tablet-based aphasia therapy via the adherence rate,
Description
Adherence rate: time patients practiced versus time advised to practice + notation of reasons why patients did not practice the advised time
Time Frame
from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Title
Feasibility of a tablet-based aphasia therapy via protocol deviations
Description
Notation of any protocol deviations
Time Frame
from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Title
Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire,
Description
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)
Time Frame
date of hospital discharge, an average of 1 week
Title
Usability of a tablet-based aphasia therapy via an observational checklist
Description
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)
Time Frame
date of hospital discharge, assessed up to 20 weeks
Title
Usability of a tablet-based aphasia therapy via within-task improvements of the app
Description
Notation of exercises performed with the app
Time Frame
from date of inclusion to date of hospital discharge, assessed up to 20 weeks
Title
Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction
Description
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)
Time Frame
date of hospital discharge, an average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veerle De Herdt
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, department of neurology
City
Gent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33418143
Citation
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.
Results Reference
derived

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Tablet-based Aphasia Therapy in the Acute Phase After Stroke

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