Efficacy Of Intensive Tele-Rehabilitation Combined With Donepezil Compared To Face-to-face Administration

Abstract

Objectives: (a) To evaluate the benefits promoted by two modalities of intensive language-action therapy, telerehabilitation (Tele-ILAT) and face-to-face (ILAT), applied alone and in combination with Donepezil to persons with chronic post-stroke aphasia (PSA) (phase 1). (b) To examine the best remote or hybrid strategy to maintain the gains in language and language-affiliated behaviours (communication, psychological adjustment, and quality of life) promoted by both modalities of ILAT, and to determine the efficacy of these interventions in reducing the therapist burden (phase 2). (c) To identify potential predictors of treatment response, including gene markers, and to detect changes in language, cognition, emotional functions and neural plasticity using multimodal MRI. Methodology: Estimated sample size: 48 participants with chronic PSA are required to obtain a power of 80% ( increment of 5 points ± 4) relative to baseline scores on the Western Aphasia Battery-Revised. Methods and design: a randomized control trial involving four groups comparing the effectiveness of ILAT applied online, and face-to-face administered alone and with Donepezil (phase 1); three quasi-randomised parallel groups (asynchronous, hybrid and control) (phase 2). Results and conclusions: Primary outcome measures: aphasia severity, communication, behaviour, and quality of life. Evaluations will determine potential predictive variables of response, as well as brain and language changes associated with the treatments at different timepoints. This trial will determine: (a) whether Tele-ILAT administered alone and combined with Donepezil reduces aphasia severity and language-affiliated deficits in the same manner as face-to-face ILAT and the contribution of adding Donepezil to these interventions; (b) the best long-term remote maintenance-therapy.