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.
