AphasiaNCT03679637
Tablet-based Aphasia Therapy in the Acute Phase After Stroke
A study testing Tablet-based aphasia therapy in people with Aphasia and Stroke, Acute, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Stroke, Acute
- What is being tested?
- Tablet-based aphasia therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Sep 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of severe psychiatric disorders and/or cognitive disorders that hinder the use of the tablet-based aphasia therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aphasia, Stroke, Acute
- Being tested
- Tablet-based aphasia therapy
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-based aphasia therapyBehavioural
patients will independently practice with a speech app during hospitalisation
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Each participant will receive a tablet-based aphasia therapy Receives: Behavioral: Tablet-based aphasia therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: date of hospital discharge, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start28 Sep 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neurologie, University Hospital, Ghent
- Investigators
- Veerle De Herdt, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679637
- Sponsor's protocol ID
- EC/2018/1006
- Status last verified
- Apr 2020
- First submitted
- 7 Sep 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33418143
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility, Usability and Acceptability of a Tablet-based Aphasia Therapy in the Acute Phase After Stroke
- ClinicalTrials.gov ID
- NCT03679637
- Acronym / sponsor ID
- EC/2018/1006
- Conditions
- Aphasia, Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Tablet-based aphasia therapyEach participant will receive a tablet-based aphasia therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of severe psychiatric disorders and/or cognitive disorders that hinder the use of the tablet-based aphasia therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tablet-based aphasia therapypatients will independently practice with a speech app during hospitalisation | Behavioural | Intervention group |
Primary outcome
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
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
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
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
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)
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)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 33418143De 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veerle De Herdt principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet-based aphasia therapy in people with Aphasia and Stroke, Acute, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.