Stroke Clinical Trial
Official title:
Treatment of Grammatical Time Marking in Post-Stroke Aphasia: a Study of French-Speaking Subjects With Chronic Fluent and Non-fluent Aphasia
Verified date | May 2024 |
Source | University of Neuchatel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | April 16, 2024 |
Est. primary completion date | April 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Université de Neuchâtel | Neuchâtel |
Lead Sponsor | Collaborator |
---|---|
University of Neuchatel |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy) | |
Primary | 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. |
Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy) | |
Primary | 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. |
Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy) | |
Primary | 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. |
Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy) | |
Primary | 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. |
Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up | |
Primary | 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. |
Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up | |
Primary | 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. |
Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up | |
Primary | 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. |
Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up | |
Primary | 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. |
Baselines, 2-4 weeks follow-up | |
Primary | 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. |
Baselines, 2-4 weeks follow-up | |
Primary | 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. |
Baselines, 2-4 weeks follow-up | |
Primary | 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. |
Baselines, 2-4 weeks follow-up | |
Secondary | 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. |
Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy) | |
Secondary | 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. |
Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up | |
Secondary | 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. |
Baselines, 2-4 weeks follow-up | |
Secondary | 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. |
Baselines, middle of the treatment (after 2 weeks of treatment), post-treatment (24-48 hours after the last session of the therapy) | |
Secondary | 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. |
Post-treatment (24-48 hours after the last session of the therapy), 2-4 weeks follow-up | |
Secondary | 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. |
Baselines, 2-4 weeks follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|