Clinical trial NCT04289493: DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke
Official title: DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke (DULCINEA). A Feasibility Cross-over Pilot-trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia, Post-Ictal
Keywords: Rehabilitation
Word dubbing
Functional communication
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Universidad Pontificia Comillas
name: Asociación Afasia Activa
name: La Caixa Foundation
First posted: 2020-02-28
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two groups with 27 patients in each one. Group 1 starts therapy in the first 3 months since study inclusion and from months 3-6 is group 2 control. Group 2 starts language therapy from months 3-6, serving previously as group 1 control.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from TV series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia from the departments of Neurology and Rehabilitation from La Paz University Hospital and also from the "Afasia Activa" association. After meeting all inclusion and none of the exclusion criteria and signing informed consent, patients will be randomised (1:1) in two different treatment groups. The first group will receive therapy within the first 3 months of their inclusion with a subsequent period of another 3 months without therapy (thus, serving as group 2 controls). Group 2 will initiate therapy after 3 months since their inclusion (serving as group 1 controls during the first 3 months). Therapy consists of 17 sessions performed in a eight week period (1 baseline session and 16 dubbing sessions), each lasting 40 minutes, in which the patient will be asked to dubb words or sentences previously selected and considered as functionally meaningful for them. These words will be chosen through an online survey performed by a representative group of aphasic patients and the study patients´own relatives in the baseline treatment session. Outcomes will be assessed as significant differences in two aphasia tests (CAL questionnaire and the BDAE).

Eligibility criteria: 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.

Primary outcomes:
measure: Communicative Activity Log (CAL) questionnaire
timeFrame: Changes in score at six months
measure: Boston Diagnostic Aphasia Examination (BDAE)
timeFrame: Changes in score at six months
Secondary outcomes:
measure: General Health Questionnaire (GQH-12)
timeFrame: Changes in score at six months
measure: Stroke and aphasia Quality of Life Scale (SAQOL-39)
timeFrame: Changes in score at six months
measure: Western Aphasia Battery Revised (WAB-R)
timeFrame: Changes in score at six months
measure: Stroke Aphasic Depression Questionnaire (SADQ10)
timeFrame: Changes in score at six months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
References:
citation: Fuentes B, de la Fuente-Gomez L, Sempere-Iborra C, Delgado-Fernandez C, Tarifa-Rodriguez A, Alonso de Lecinana M, de Celis-Ruiz E, Gutierrez-Zuniga R, Lopez-Tappero J, Martin Alonso M, Pastor-Yborra S, Rigual R, Ruiz-Ares G, Rodriguez-Pardo J, Virues-Ortega J, Borobia AM, Blanco P, Bueno-Guerra N. DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial. Trials. 2022 Jan 6;23(1):21. doi: 10.1186/s13063-021-05956-5.