A single-blind randomized trial on the efficacy of telerehabilitation in post-stroke cognitive impairment. CIPS-TER Study: rationale, design and methodology

Eleonora Barucci¹Arianna Cavaliere¹Eleonora Pavan²Bendetta Formelli^1,3Francesca Cecchi^2,4Cristina Polito²Giulia Salti³Filippo Fratini¹Costanza Parenti⁵Francesca Pescini³Giacomo Redi⁵Marzia Baldereschi⁵Antonio Di Carlo⁵Emilia Salvadori⁶Anna Poggesi^1,3*

• ¹NEUROFARBA Department, Neuroscience Section, University of Florence, Florence, Italy, Florence, Tuscany, Italy
• ²IRCCS Don Carlo Gnocchi Firenze, Florence, Tuscany, Italy
• ³Stroke Unit, Careggi Hospital, Florence, Tuscany, Italy
• ⁴Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
• ⁵Institute of Neuroscience, Italian National Research Council, Florence, Italy
• ⁶Department of Biomedical and Clinical Sciences, Faculty of Medicine and Surgery, University of Milan, Milan, Lombardy, Italy

Background and aims: Cognitive impairment (CI) after stroke is still a neglected consequence compared to other neurological deficits for which rehabilitation pathways are routinely available. Cognitive teleRehabilitation (CTR) represents an emerging approach that has the potential to reduce healthcare costs and potentially reaching many patients. By means of a randomized controlled trial, the aims are to investigate the prevalence of cognitive impairment after stroke and the efficacy of a CTR program in: a) reducing the risk of CI 6 months after stroke; b) generalizability of the cognitive training to real life; c) impact on cognitive performances. In the treated group, feasibility, adherence and appreciation of the CTR will also be evaluated.The CIPS-TER study is a 2-year prospective, single-blind, randomized clinical trial. One hundred patients with ischemic or hemorrhagic stroke will be enrolled in the study, within 5-21 days after onset, and randomized to treatment or standard care. The CTR program will consist of up to 40 hours (8 weeks) of individual treatment based on memory, attention, executive functions, and visuospatial tasks to be autonomously performed with a tablet. The study outcomes will be evaluated at 6-month follow-up visit and will include the diagnosis of cognitive impairment, activities of daily living, quality of life, changes in frailty status and cognitive efficiency.Conclusions: CIPS-TER study will expand our knowledge on the potential effect of cognitive rehabilitation on future cognitive and functional decline after stroke.