AphasiaNCT03622411
Tablet-based Aphasia Therapy in the Chronic Phase
A study testing speech app, brain games and aphasia therapy in people with Aphasia and Stroke, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- speech app, brain games and aphasia therapy
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Sep 2018to 23 Feb 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with mild-severe aphasia (token test score between 7 and 49) after a left hemispheric ischemic or hemorrhagic 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- speech app, brain games, 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.
speech appDevice
language exercises provided by the speech therapist in hospital + independent practice of language exercises via a tablet and speech app
brain gamesDevice
language exercises provided by the speech therapist in hospital + independent recreational tablet use via brain games
aphasia therapyBehavioural
language exercises provided by the speech therapist in hospital
| Study group | Role | What they receive |
|---|---|---|
| aphasia therapy + speech app | Experimental | 3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks independent practice via the speech app Receives: Device: speech app; Behavioral: aphasia therapy |
| aphasia therapy + brain games | Active comparator | 3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks of recreational tables use (brain games) Receives: Device: brain games; Behavioral: aphasia therapy |
| aphasia therapy | Active comparator | 3 hours per week of conventional aphasia therapy during 3 weeks Receives: Behavioral: aphasia therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Naming Test (BNT)
Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty
Measured: 4 months
Secondary outcomes (3)
Spontaneous speech of the Aachen Aphasia Test (AAT)
spontaneous speech is elicited and scored during a semi-standardized interview
Measured: 4 months
Quality of life (SAQOL-39-Nl)
a questionnaire investigating the health-related quality of life of patients following stroke
Measured: 4 months
Usability questionnaire
a self-prepared 5 point-Likert Scale concerning the usability of the app
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start7 Sep 2018
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veerle De Herdt, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622411
- Sponsor's protocol ID
- EC/2018/0909
- Status last verified
- Jan 2023
- First submitted
- 6 Aug 2018
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Tablet-based Aphasia Therapy in the Chronic Phase After Stroke
- ClinicalTrials.gov ID
- NCT03622411
- Acronym / sponsor ID
- EC/2018/0909
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 9 Aug 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aphasia therapy + speech app | Experimental | Device: speech app, Behavioral: aphasia therapy3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks independent practice via the speech app |
| aphasia therapy + brain games | Active comparator | Device: brain games, Behavioral: aphasia therapy3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks of recreational tables use (brain games) |
| aphasia therapy | Active comparator | Behavioral: aphasia therapy3 hours per week of conventional aphasia therapy during 3 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed with mild-severe aphasia (token test score between 7 and 49) after a left hemispheric ischemic or hemorrhagic 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| speech applanguage exercises provided by the speech therapist in hospital + independent practice of language exercises via a tablet and speech app | Device | aphasia therapy + speech app |
| brain gameslanguage exercises provided by the speech therapist in hospital + independent recreational tablet use via brain games | Device | aphasia therapy + brain games |
| aphasia therapylanguage exercises provided by the speech therapist in hospital | Behavioural | aphasia therapy, aphasia therapy + brain games, aphasia therapy + speech app |
Primary outcome
Boston Naming Test (BNT)
Time frame: 4 months
Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty
3 secondary outcomes
Spontaneous speech of the Aachen Aphasia Test (AAT)
Time frame: 4 months
Quality of life (SAQOL-39-Nl)
Time frame: 4 months
Usability questionnaire
Time frame: 1 day
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 10 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Aphasia
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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 speech app, brain games and aphasia therapy in people with Aphasia and Stroke, 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 5 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 10 Jan 2023. 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?
Boston Naming Test (BNT) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2023.