| 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. |
