DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial

Trials

Paloma Blanco¹  Alberto M. Borobia²  Blanca Fuentes³  Gerardo Ruiz-Ares³  María Alonso de Leciñana³  Raquel Gutiérrez-Zúñiga³  Ricardo Rigual³  Jorge Rodríguez-Pardo³  Sylvia Pastor-Yborra³  Elena de Celis-Ruiz³  Aida Tarifa-Rodríguez⁴  Javier Virués-Ortega⁵  Nereida Bueno-Guerra⁶  Cristian Sempere-Iborra⁷  Lydia de la Fuente-Gómez⁷  Celia Delgado-Fernández⁷  José López-Tàppero⁸  Marta Martín Alonso⁹ 

[1] Asociación Afasia Activa, Madrid, Spain;Clinical Trials Unit, Department of Clinical Pharmacology, La Paz University Hospital, IdiPAZ Institute for Health Research, Madrid, Spain;Department of Neurology and Stroke Center, La Paz University Hospital, Department of Medicine, Neurosciences Unit, Universidad Autónoma de Madrid, IdiPAZ Institute for Health Research, Madrid, Spain;Department of Psychology, Universidad Autónoma de Madrid, Madrid, Spain;Department of Psychology, Universidad Autónoma de Madrid, Madrid, Spain;The University of Auckland, Auckland, New Zealand;Department of Psychology, Universidad Pontificia Comillas, Madrid, Spain;Neurosciences Area, IdiPAZ Institute for Health Research, Madrid, Spain;Speech and Language Unit, Department of Rehabilitation, La Paz University Hospital and Universidad Complutense de Madrid, Madrid, Spain;Speech and Language Unit, Department of Rehabilitation, La Paz University Hospital, Madrid, Spain;

关键词: Stroke;    Aphasia;    Randomized clinical trial;    Protocol;   

DOI  :  10.1186/s13063-021-05956-5

来源: Springer

【 摘 要 】

BackgroundCommunication is one of the most important predictors of social reintegration after stroke. Approximately 15–42% of stroke survivors experience post-stroke aphasia. Helping people recover from aphasia is one of the research priorities after a stroke. Our aim is to develop and validate a new therapy integrating dubbing techniques to improve functional communication.MethodsThe research project is structured as three work packages (WP). WP1: development of the dubbed language cinema-based therapy: Two research assistants (a speech therapist and a dubbing actor) will select the clips, mute specific words/sentences in progressive speech difficulty, and guide patients to dub them across sessions. Words to be dubbed will be those considered to be functionally meaningful by a representative sample of aphasic patients and relatives through an online survey. WP2: a randomized, crossover, interventional pilot study with the inclusion of 54 patients with post-stroke non-fluent aphasia. Patients will be treated individually in 40-min sessions twice per week for 8 weeks. Primary outcomes will be significant pre/post differences in scores in the Communicative Activity Log (CAL) questionnaire and Boston Diagnostic Aphasia Examination (BDAE) administered by a psychologist blinded to the patients’ clinical characteristics. Secondary outcomes: General Health Questionnaire (GHQ)-12, Stroke Aphasia Quality of Life Scale (SAQOL-39), Western Aphasia Battery Revised (WAB-R), and the Stroke Aphasic Depression Questionnaire (SADQ10). WP3: educational activities and dissemination of results. WP3 includes educational activities to improve public knowledge of aphasia and dissemination of the results, with the participation of the Spanish patients’ association Afasia Activa.DiscussionThis pilot clinical trial will explore the efficacy of a new therapeutic tool based on dubbing techniques and computer technology to improve functional communication of patients suffering from post-stroke aphasia with the use of standardized test assessment.Trial registrationClinicalTrials.govNCT04289493. Registered on 28 February 2020.

【 授权许可】

CC BY