Ana M Haro-Martínez1, Genny Lubrini2,3, Rosario Madero-Jarabo4, Exuperio Díez-Tejedor2, Blanca Fuentes2. 1. 1 PhD Program, School of Medicine, Autonomous University of Madrid, Madrid, Spain. 2. 2 Department of Neurology and Stroke Center, La Paz University Hospital, IdiPAZ Health Research Institute, Autonomous University of Madrid, Madrid, Spain. 3. 3 School of Health Sciences, Francisco de Vitoria University, Madrid, Spain. 4. 4 Department of Biostatistics, La Paz University Hospital, IdiPAZ Health Research Institute, Autonomous University of Madrid, Madrid, Spain.
Abstract
OBJECTIVE: : To collect data to estimate the sample size of a definitive randomized controlled trial to evaluate the effects of Melodic Intonation Therapy in post-stroke nonfluent aphasia. DESIGN: : A randomized, crossover, interventional pilot trial. SETTING: : Departments of Neurology and Rehabilitation from a university general hospital. PARTICIPANTS:: Stroke survivors with post-stroke nonfluent aphasia. INTERVENTIONS: : Patients randomized to group 1 had treatment with Melodic Intonation Therapy first (12 sessions over six weeks) followed by no treatment; the patients in group 2 started active treatment between three and six months after their inclusion in the study, serving as waiting list controls for the first phase. MAIN MEASURES:: The Communicative Activity Log (CAL) questionnaire and the Boston Diagnostic Aphasia Examination (BDAE) were evaluated at baseline, and at six and 12 weeks. RESULTS: : Twenty patients were included. Four of the patients allocated to group 2 crossed over to group 1, receiving the treatment at first. Intention-to-treat analysis: after adjustment for baseline scores, the mean difference in the CAL evaluation from baseline in the treated group was 8.5 points (95% confidence interval (CI), 0.11-17.0; P = .043), with no significant change in any of the BDAE sections. Per-protocol analysis showed similar results with a clear treatment effect ( P = .043) on the CAL. CONCLUSION: : Melodic Intonation Therapy might have a positive effect on the communication skills of stroke survivors with nonfluent aphasia as measured by the CAL questionnaire. A full-scale trial with at least 27 patients per group is necessary to confirm these results.
RCT Entities:
OBJECTIVE: : To collect data to estimate the sample size of a definitive randomized controlled trial to evaluate the effects of Melodic Intonation Therapy in post-stroke nonfluent aphasia. DESIGN: : A randomized, crossover, interventional pilot trial. SETTING: : Departments of Neurology and Rehabilitation from a university general hospital. PARTICIPANTS:: Stroke survivors with post-stroke nonfluent aphasia. INTERVENTIONS: : Patients randomized to group 1 had treatment with Melodic Intonation Therapy first (12 sessions over six weeks) followed by no treatment; the patients in group 2 started active treatment between three and six months after their inclusion in the study, serving as waiting list controls for the first phase. MAIN MEASURES:: The Communicative Activity Log (CAL) questionnaire and the Boston Diagnostic Aphasia Examination (BDAE) were evaluated at baseline, and at six and 12 weeks. RESULTS: : Twenty patients were included. Four of the patients allocated to group 2 crossed over to group 1, receiving the treatment at first. Intention-to-treat analysis: after adjustment for baseline scores, the mean difference in the CAL evaluation from baseline in the treated group was 8.5 points (95% confidence interval (CI), 0.11-17.0; P = .043), with no significant change in any of the BDAE sections. Per-protocol analysis showed similar results with a clear treatment effect ( P = .043) on the CAL. CONCLUSION: : Melodic Intonation Therapy might have a positive effect on the communication skills of stroke survivors with nonfluent aphasia as measured by the CAL questionnaire. A full-scale trial with at least 27 patients per group is necessary to confirm these results.
Authors: Blanca Fuentes; Nereida Bueno-Guerra; Lydia de la Fuente-Gómez; Cristian Sempere-Iborra; Celia Delgado-Fernández; Aida Tarifa-Rodríguez; María Alonso de Leciñana; Elena de Celis-Ruiz; Raquel Gutiérrez-Zúñiga; José López-Tàppero; Marta Martín Alonso; Sylvia Pastor-Yborra; Ricardo Rigual; Gerardo Ruiz-Ares; Jorge Rodríguez-Pardo; Javier Virués-Ortega; Alberto M Borobia; Paloma Blanco Journal: Trials Date: 2022-01-06 Impact factor: 2.279