Brain Injury, VascularNCT05656638
Treatment of Grammatical Time Marking in Post-Stroke Aphasia
A study testing Speech and language therapy in people with Brain Injury, Vascular and Aphasia, run by University of Neuchatel at 1 site in Switzerland.
Trial summary
The study aims to assess an individual or self-administered computer therapy's effectiveness in grammatical time marking. The main objective is to examine whether the therapy improves grammatical time marking of inflected verbs treated on the sessions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injury, Vascular, Aphasia, Stroke
- What is being tested?
- Speech and language therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Dec 2022to 16 Apr 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had an imaging-objectified stroke in adulthood that resulted in aphasia (fluent or non-fluent). The time between the stroke and participation in this study must be greater than 6 months.
- Be a native French speaker or have excellent mastery of French.
- Be between 18 and 75 years old.
- Present grammatical tense marking disorders objectified by language evaluation (deficit scores on the "Batterie d'Évaluation de la Production Syntaxique" (BEPS) verb flexion task, Monetta et al., 2018; and/or on the "Test d'expression morpho-syntaxique fine" (T.E.M.F.) active sentence production subtask, Bernaert-Paul and Simonin, 2011).
Who cannot join
- Present chronic symptoms of a substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
- Have significant uncorrected vision and/or hearing impairment.
- Have significant impairments in oral/written comprehension.
- Present apraxia of speech or a severe arthritic disorder
- Present hemineglect
- Present impaired judgment and discernment, objectified by a neuropsychological evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Grammatical Time Marking in Post-Stroke Aphasia: a Study of French-Speaking Subjects With Chronic Fluent and Non-fluent Aphasia
The study aims to assess an individual or self-administered computer therapy's effectiveness in grammatical time marking. The main objective is to examine whether the therapy improves grammatical time marking of inflected verbs treated on the sessions. We also explore whether the observed progress can be transferred to untrained items, more ecological contexts and if is maintained two and four weeks after the end of treatment.
This therapy will be administered to six individuals with brain lesions after stroke. Four individuals will take part of the individual therapy and two individuals will take part of the self-administered computer therapy. The therapy will last one month, at the rate of three weekly sessions of approximately one hour.
- Conditions
- Brain Injury, Vascular, Aphasia, Stroke
- Being tested
- Speech and language therapy
- Medical subject headings
- Cerebrovascular Trauma, Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech and language therapyBehavioural
The treatment focuses on grammatical time marking. The aim of the treatment is to train underlying grammatical time marking processes, which were identified as deficient during a preliminary evaluation. The intervention is composed of 4 steps inspired by models and hypotheses from the literature on the subject. Step 1: "temporal adverbial selection", subject must identify the tense encoded in sentences and select the correct adverbial among those proposed. Step 2: "selection of inflected verb forms", subject must identify the tense encoded in the sentence and select the correct verb form among those proposed. Step 3: "production of inflected verb forms", subject must identify the tense encoded in the sentence and produce inflected verbs. Step 4: "semantic narration", subject must describe scenes using verbs inflected according to the previously defined reference time.
| Study group | Role | What they receive |
|---|---|---|
| Brain-injured participants | Experimental | Participants with post-stroke fluent or non-fluent chronic aphasia Receives: Behavioral: Speech and language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the score on an inflected verb production task after the end of the therapy: treated items
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference.
The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Measured: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
Change from time accuracy on a semantic narration task after the end of the therapy: treated semantic narrations
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in semantic narration task is calculated using ratios.
The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Measured: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
Change from the score on an inflected verb production task after the end of the therapy: untreated items
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference.
The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Measured: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
Change from time accuracy on a semantic narration task after the end of the therapy: untreated semantic narrations
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in semantic narration task is calculated using ratios.
The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Measured: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: treated items
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference.
The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Measured: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: untreated items
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference.
The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Measured: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: treated semantic narrations
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios.
The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Measured: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: untreated semantic narrations
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios.
The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Measured: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: treated items
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference.
The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Measured: Baselines, 2-4 weeks follow-up
Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: untreated items
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference.
The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Measured: Baselines, 2-4 weeks follow-up
Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: treated semantic narrations
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios.
The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Measured: Baselines, 2-4 weeks follow-up
Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: untreated semantic narrations
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios.
The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Measured: Baselines, 2-4 weeks follow-up
Secondary outcomes (6)
Change from time accuracy on an episodic/procedural narration task after the end of the therapy
The episodic/procedural narration task evaluates subject's ability to produce inflected verb forms according to time context in a narrative situation. This task is administered in order to analyze the transfer of the gains of the therapy to a more ecological context (as it is free of verbal or pictorial support). The accuracy of time marking in the semantic narration task is calculated using ratios.
The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Measured: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
Change from time accuracy on an episodic/procedural narration task 2 and 4 weeks after the end of the therapy
The episodic/procedural narration task evaluates subject's ability to produce inflected verb forms according to time context in a narrative situation. This task is administered in order to analyze the transfer of the gains of the therapy to a more ecological context (as it is free of verbal or pictorial support). The accuracy of time marking in the semantic narration task is calculated using ratios.
The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Measured: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
Change from time accuracy on an episodic/procedural narration task 2 and 4 weeks after the end of the therapy
The episodic/procedural narration task evaluates subject's ability to produce inflected verb forms according to time context in a narrative situation. This task is administered in order to analyze the transfer of the gains of the therapy to a more ecological context (as it is free of verbal or pictorial support). The accuracy of time marking in the semantic narration task is calculated using ratios.
The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Measured: Baselines, 2-4 weeks follow-up
Change at a control task after the end of the therapy
The control task ensures that progress is specific to the treatment. This task is specific to each participant: it is a logopedic/neuropsychological test for which the participant has deficit scores and whose content is not influenced by the treatment (e.g., a test on calculation).
The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Measured: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
Change at a control task 2 and 4 weeks after the end of the therapy
The control task ensures that progress is specific to the treatment. This task is specific to each participant: it is a logopedic/neuropsychological test for which the participant has deficit scores and whose content is not influenced by the treatment (e.g., a test on calculation).
The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Measured: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
Change at a control task 2 and 4 weeks after the end of the therapy
The control task ensures that progress is specific to the treatment. This task is specific to each participant: it is a logopedic/neuropsychological test for which the participant has deficit scores and whose content is not influenced by the treatment (e.g., a test on calculation).
The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Measured: Baselines, 2-4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start30 Dec 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, VascularStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Neuchatel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion Fossard, University of Neuchatel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656638
- Sponsor's protocol ID
- Unine2022-01807
- Status last verified
- May 2024
- First submitted
- 1 Dec 2022
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Grammatical Time Marking in Post-Stroke Aphasia: a Study of French-Speaking Subjects With Chronic Fluent and Non-fluent Aphasia
- ClinicalTrials.gov ID
- NCT05656638
- Acronym / sponsor ID
- Unine2022-01807
- Conditions
- Brain Injury, Vascular, Aphasia, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of NeuchatelUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 19 Dec 2022 (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.
The study aims to assess an individual or self-administered computer therapy's effectiveness in grammatical time marking. The main objective is to examine whether the therapy improves grammatical time marking of inflected verbs treated on the sessions. We also explore whether the observed progress can be transferred to untrained items, more ecological contexts and if is maintained two and four weeks after the end of treatment.
This therapy will be administered to six individuals with brain lesions after stroke. Four individuals will take part of the individual therapy and two individuals will take part of the self-administered computer therapy. The therapy will last one month, at the rate of three weekly sessions of approximately one hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain-injured participants | Experimental | Behavioral: Speech and language therapyParticipants with post-stroke fluent or non-fluent chronic aphasia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have had an imaging-objectified stroke in adulthood that resulted in aphasia (fluent or non-fluent). The time between the stroke and participation in this study must be greater than 6 months.
- Be a native French speaker or have excellent mastery of French.
- Be between 18 and 75 years old.
- Present grammatical tense marking disorders objectified by language evaluation (deficit scores on the "Batterie d'Évaluation de la Production Syntaxique" (BEPS) verb flexion task, Monetta et al., 2018; and/or on the "Test d'expression morpho-syntaxique fine" (T.E.M.F.) active sentence production subtask, Bernaert-Paul and Simonin, 2011).
Key exclusion criteria (6 listed)
- Present chronic symptoms of a substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
- Have significant uncorrected vision and/or hearing impairment.
- Have significant impairments in oral/written comprehension.
- Present apraxia of speech or a severe arthritic disorder
- Present hemineglect
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 and language therapyThe treatment focuses on grammatical time marking. The aim of the treatment is to train underlying grammatical time marking processes, which were identified as deficient during a preliminary evaluation. The intervention is composed of 4 steps inspired by models and hypotheses from the literature on the subject. Step 1: "temporal adverbial selection", subject must identify the tense encoded in sentences and select the correct adverbial among those proposed. Step 2: "selection of inflected verb forms", subject must identify the tense encoded in the sentence and select the correct verb form among those proposed. Step 3: "production of inflected verb forms", subject must identify the tense encoded in the sentence and produce inflected verbs. Step 4: "semantic narration", subject must describe scenes using verbs inflected according to the previously defined reference time. | Behavioural | Brain-injured participants |
Primary outcome
Change from the score on an inflected verb production task after the end of the therapy: treated items
Time frame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Change from time accuracy on a semantic narration task after the end of the therapy: treated semantic narrations
Time frame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in semantic narration task is calculated using ratios. The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Change from the score on an inflected verb production task after the end of the therapy: untreated items
Time frame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Change from time accuracy on a semantic narration task after the end of the therapy: untreated semantic narrations
Time frame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in semantic narration task is calculated using ratios. The task will be administered three times before the therapy (baselines), once in the middle of the therapy (after 2 weeks of treatment) and directly (24-48 hours) after the last session of the therapy (post-treatment) to analyze the change of performance.
Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: treated items
Time frame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: untreated items
Time frame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: treated semantic narrations
Time frame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios. The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: untreated semantic narrations
Time frame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios. The task will be administered directly (24-48 hours) after the last session of the therapy (post-treatment) and 2-4 weeks after the treatment (follow-up) to analyze the maintenance of performance.
Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: treated items
Time frame: Baselines, 2-4 weeks follow-up
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Change from the score on an inflected verb production task 2 and 4 weeks after the end of the therapy: untreated items
Time frame: Baselines, 2-4 weeks follow-up
The inflected verb production task evaluates subject's ability to produce an inflected verb form according to time context given by a short sentence. The score is obtained by adding the points (0 or 1) obtained for each item and is calculated per time reference. The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: treated semantic narrations
Time frame: Baselines, 2-4 weeks follow-up
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios. The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
Change from time accuracy on a semantic narration task 2 and 4 weeks after the end of the therapy: untreated semantic narrations
Time frame: Baselines, 2-4 weeks follow-up
The semantic narration task evaluates subject's ability to produce inflected verb forms according to time context. Semantic narrations are based on imagined stories and according to a given temporal frame. This task includes 2 pictorial sequences per temporal reference. The accuracy of time marking in the semantic narration task is calculated using ratios. The task will be administered three times before the therapy (baselines) and 2-4 weeks after the treatment (follow-up) to analyze the long-term change of performance.
6 secondary outcomes
Change from time accuracy on an episodic/procedural narration task after the end of the therapy
Time frame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
Change from time accuracy on an episodic/procedural narration task 2 and 4 weeks after the end of the therapy
Time frame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
Change from time accuracy on an episodic/procedural narration task 2 and 4 weeks after the end of the therapy
Time frame: Baselines, 2-4 weeks follow-up
Change at a control task after the end of the therapy
Time frame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)
Change at a control task 2 and 4 weeks after the end of the therapy
Time frame: Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up
Change at a control task 2 and 4 weeks after the end of the therapy
Time frame: Baselines, 2-4 weeks follow-up
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 14 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and language therapy in people with Brain Injury, Vascular and Aphasia, run by University of Neuchatel at 1 site in Switzerland.
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 4 inclusion and 6 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 14 May 2024. 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 Switzerland. 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?
Change from the score on an inflected verb production task after the end of the therapy: treated items (time frame: Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy)). The study lists 12 primary outcomes in all. 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 14 May 2024.