NCT04289493Completed
DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke
DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke (DULCINEA). A Feasibility Cross-over Pilot-trial
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 20 Feb 2020
- Start date
- 18 Dec 2020
- Primary completion date
- 27 Sept 2024
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Diseases
- Stroke
- NCT number
- NCT04289493
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 18 Dec 2020 to the primary completion date, 27 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any clinical condition (short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up.
Other
- Participation in any therapeutic trial evaluating poststroke recovery.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| La Paz University Hospital Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.