DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Aphasia, Post-Ictal

Treatments: Other: Language and functional communication therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04289493

DULCINEA

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Group 1: first to receive therapy

Experimental group

Description:

27 patients that will receive study specific speech therapy in the first 3 months since study inclusion. From months 3-6 they will be group 2 controls.

Treatment:

Other: Language and functional communication therapy

Group 2: second to receive therapy

Experimental group

Description:

27 patients that will receive study specific speech therapy during months 3-6 since study inclusion. During the first 3 months of the study period, they will be group 1 controls.

Treatment:

Other: Language and functional communication therapy