Abstract
Background
Cognitive rehabilitation is a highly individualised, non-pharmacological intervention for people with mild cognitive impairment (MCI) and dementia, which in recent years has also been developed for various IT platforms.
Methods
In this study, we aim to evaluate the effectiveness of the cognitive rehabilitation software GRADIOR in a multi-centre, single-blinded randomised controlled trial with people with MCI and mild dementia. A total of 400 people with MCI and mild dementia will be randomly allocated to one of four groups. This trial will compare the cognitive rehabilitation treatment using the GRADIOR programme with a psychosocial stimulation intervention (PSS) using the ehcoBUTLER platform, with a combined treatment consisting of GRADIOR and ehcoBUTLER, and with a group receiving treatment as usual during a period of 1 year.
Discussion
The outcomes of this clinical trial will be to determine any relevant changes in cognition, mood, quality of life, activities of daily living and quality of patient-carer relationship after 4 months and 1 year of intervention in a cross-sectional group comparison. Participants will be followed-up for 1 year to investigate potential long-term effects of the conducted treatments.
Trial registration
Current Controlled Trials ISRCTN, ID: 15742788. Registered on 12 June 2017.
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Details
; Irazoki, Eider 2 ; García-Casal, J. Antonio 3 ; Martínez-Abad, Fernando 4 ; Botella, Cristina 5 ; Shiells, Kate R. 6 ; Franco-Martín, Manuel A. 1 1 University of Salamanca, Institute of Biomedical Research, Salamanca, Spain (GRID:grid.11762.33) (ISNI:0000 0001 2180 1817); INTRAS Foundation, Zamora, Spain (GRID:grid.11762.33)
2 University of Salamanca, Faculty of Psychology, Salamanca, Spain (GRID:grid.11762.33) (ISNI:0000 0001 2180 1817); INTRAS Foundation, Zamora, Spain (GRID:grid.11762.33)
3 University of Salamanca, Faculty of Psychology, Salamanca, Spain (GRID:grid.11762.33) (ISNI:0000 0001 2180 1817)
4 University of Salamanca, Faculty of Education, Salamanca, Spain (GRID:grid.11762.33) (ISNI:0000 0001 2180 1817)
5 Universitat Jaume I, Department of Basic and Clinical Psychology and Psychobiology, Castellón, Spain (GRID:grid.9612.c) (ISNI:0000 0001 1957 9153); CB06/03 Instituto Salud Carlos III, Ciber Fisiopatología Obesidad y Nutrición, Madrid, Spain (GRID:grid.413448.e) (ISNI:0000 0000 9314 1427)
6 Charles University, Centre of Gerontology, Faculty of Humanities, Prague, Czech Republic (GRID:grid.4491.8) (ISNI:0000 0004 1937 116X)




