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

NCT04289493 | Completed DMC

• 1 other identifier: DULCINEA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia, Post-Ictal

Keywords

Rehabilitation; Word dubbing; Functional communication

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• General Health Questionnaire (GQH-12)

  Changes in score at six months

• Stroke and aphasia Quality of Life Scale (SAQOL-39)

  Changes in score at six months

• Western Aphasia Battery Revised (WAB-R)

  Changes in score at six months

• Stroke Aphasic Depression Questionnaire (SADQ10)

  Changes in score at six months

Study Arms (2)

Group 1: first to receive therapy

EXPERIMENTAL

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.

Other: Language and functional communication therapy

Group 2: second to receive therapy

EXPERIMENTAL

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.

Other: Language and functional communication therapy

Interventions

Language and functional communication therapy OTHER

17 therapy sessions in which the patients will be asked to dubb words or sentences from television series previously considered functionally meaningful for them.

Group 1: first to receive therapy; Group 2: second to receive therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any clinical condition (short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up.
• Participation in any therapeutic trial evaluating poststroke recovery.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Universidad Pontificia Comillas: collaborator
• Asociación Afasia Activa: collaborator
• La Caixa Foundation: collaborator

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 34991688 DERIVED

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A psychologist blinded to the patient´s clinical characteristics and study groups performs the outcome questionnaires three times for each patient during the study period.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 28, 2020
• Study Start: December 18, 2020
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)