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

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.

Study Overview

• Status: Recruiting
• Conditions: Aphasia, Post-Ictal
• Intervention / Treatment: Other: Language and functional communication therapy

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).

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blanca Fuentes Gimeno; Phone Number: +34 917277444; Email: blanca.fuentes@salud.madrid.org
• Study Contact Backup: Name: Elena de Celis Ruiz; Phone Number: +34 917277444; Email: elena.decelis.ruiz@idipaz.es

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • La Paz University Hospital
    • Principal Investigator: Blanca Fuentes Gimeno
    • Sub-Investigator: Silvia Pastor Yvorra
    • Sub-Investigator: María Alonso de Leciñana
    • Sub-Investigator: Elena de Celis Ruiz
    • Sub-Investigator: Raquel Gutiérrez Zúñiga
    • Sub-Investigator: Ricardo Riguel Bobillo
    • Sub-Investigator: Gerardo Ruiz Ares
    • Sub-Investigator: Jorge Rodríguez Pardo
    • Contact: Blanca Fuentes Gimeno; Phone Number: +34 917277444; Email: blanca.fuentes@salud.madrid.org
    • Contact: Elena de Celis Ruiz; Phone Number: +34 917277444; Email: elena.decelis.ruiz@idipaz.es
    • Sub-Investigator: Lydia de la Fuente Gómez
    • Sub-Investigator: Cristian Sempere Iborra
    • Sub-Investigator: José López Tàppero
    • Sub-Investigator: Marta Martín Alonso
    • Sub-Investigator: Paloma Blanco
    • Sub-Investigator: Nereida Bueno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: first to receive therapy; 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; 17 therapy sessions in which the patients will be asked to dubb words or sentences from television series previously considered functionally meaningful for them.
Experimental: Group 2: second to receive therapy; 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; 17 therapy sessions in which the patients will be asked to dubb words or sentences from television series previously considered functionally meaningful for them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Universidad Pontificia Comillas; Asociación Afasia Activa; La Caixa Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Word dubbing; Functional communication
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: DULCINEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No