Aphasia, Post-Ictal Clinical Trial
Official title:
DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke (DULCINEA). A Feasibility Cross-over Pilot-trial
The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from television series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia. Patients will be treated individually in 40-minute sessions twice a week for 8 weeks. In each session, a speech therapist and an actor will select the clips with muted words or sentences that have been detected as functionally meaningful for each patient. Outcomes will be assessed as significant differences in two aphasia tests.
| Status | Recruiting |
| Enrollment | 54 |
| Est. completion date | February 2023 |
| Est. primary completion date | February 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere. - the patient should have received a standard program of conventional speech therapy after stroke, remaining with aphasia with the following characteristics: severely restricted language, poor repetition (even for single words), not exceeding the 70th percentile in the Boston Diagnostic Aphasia Examination (BDAE) for repetition. Moderately preserved language comprehension: listening comprehension exceeding the 15th percentile of BDAE (average score obtained in three areas: word comprehension, commands and complex ideational material). - Signed informed consent. Exclusion Criteria: - Any clinical condition (short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up. - Participation in any therapeutic trial evaluating poststroke recovery. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | La Paz University Hospital | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto de Investigación Hospital Universitario La Paz | Asociación Afasia Activa, La Caixa Banking Foundation (HR18-00026), Universidad Pontificia Comillas |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Communicative Activity Log (CAL) questionnaire | Questionnaire that evaluates quantity and quality of aphasic patient communication, with 18 different questions in each item. Each question belonging to these two items is answered as a 6 point scale, where 0 is the worst and 5 is the best score. | Changes in score at six months | |
| Primary | Boston Diagnostic Aphasia Examination (BDAE) | Neuropsycological battery that evaluates language skills based on perceptual modalities (auditory, visual, and gestural), processing functions (comprehension, analysis, problem-solving), and response modalities (writing, articulation, and manipulation). There are five subtests which include: conversational and expository speech, auditory comprehension, oral expression, reading, and writing. Its results can be used to classify patient's language profiles into one of the localization based classifications of aphasia, and it also provides a severity rating. | Changes in score at six months | |
| Secondary | General Health Questionnaire (GQH-12) | The General Health Questionnaire (GHQ) is a psychometric screening tool to identify common psychiatric conditions. It comprises 12 questions, each one with a four point scale answer. | Changes in score at six months | |
| Secondary | Stroke and aphasia Quality of Life Scale (SAQOL-39) | SAQOL-39 is an interview-administered self-report scale that comprises the 49 items of the SS-QOL (modified to be communicatively accessible to people with aphasia) and 4 additional items that measure speech comprehension, difficulties with decision-making and and impact of language problems on family and social life. Questions are answered with a five point scale. | Changes in score at six months | |
| Secondary | Western Aphasia Battery Revised (WAB-R) | This neuropsycological test assesses linguistic and non-linguistic skills comprised of 8 subtest (32 short tasks). It identifies aphasia and classifies the type and severity of aphasia disorders. | Changes in score at six months | |
| Secondary | Stroke Aphasic Depression Questionnaire (SADQ10) | This is a brief questionnaire with 10 items testing depression symptoms within the last week in aphasic patients. Each item scores in a four point scale. | Changes in score at six months |