Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Consorzio di Bioingeneria e Informatica Medica | UNKNOWN |
| University of Florence | OTHER |
| Gutenberg Srl | OTHER |
Not provided
Not provided
Not provided
Not provided
Aging is often associated with pathological pathway such as in Mild Cognitive Impairment (MCI), and that pathway may be associated to a high risk of dementia.
Tools for early identification of functional and cognitive decline and effectiveness of treatments in counteracting the loss of functionality to preserve MCI subjects autonomy, have been widely debated in recent years.
In literature, the importance of combined cognitive and physical training is also recognized (Karssemeijer E, 2017).
Moving from the above mentioned findings and considerations, the aim of GOAL project is to test a newly developed tele-rehabilitation platform to monitor and preserve functional and cognitive abilities in individuals affected by Mild Cognitive Impairment (MCI).
Participants will be enrolled and randomly assigned to the tele-rehabilitation (GOAL group) or usual care program (control group). A dedicated application will be developed for the GOAL group. Thanks to the application, the participant will access different contents, such as serious games to train cognitive abilities (Anguera et al,2013) and physical training video lessons to endorse daily activity. Each participant of GOAL group will be provided with a tablet, with the application installed on it, and an internet connection (if needed).
30 patients will be allocated in the treatment arm (Telerehabilitation program, GOAL group) by randomization. Randomization will be applied with a ratio of 1:1.
The Telerehabilitation program is conceived as a combined protocol to train both cognitive and physical domains. Participants will be requested to perform the cognitive training three times weekly and physical training two times weekly, on alternate days. The subject will access the Telerehabilitation contents by using a web application configured on a touchscreen notebook, that will be provided to each participant by the research institute.
Physical exercises are going to be chosen according to adaptive physical activity model, and each session will be made up of eleven exercises, divided in three categories: warm-up, strengthening and stretching/relaxation. The participants will perform the exercises according to instructions received in a sequence of videos. Every session will last 30 minutes.
Cognitive training will be based on BrainHQ exercises (BrainHQ, Posit Science,USA) which are characterized by adaptive control of the difficulty levels. The chosen exercises aim to train different cognitive domains including: attention, executive function, memory, processing speed, reasoning, and visuospatial memory. Each session will last 20 minutes, and will include four different types of exercise.
While enrolled in the 8 weeks program, participants will also be requested to wear an actigraph. The actigraph will be placed on the non-dominant arm and will be used to monitor daily activity and sleep quality.
At the end of the tele-rehabilitation program, participants will undergo a final assessment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-rehabilitation | Experimental | Tele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises |
|
| Control group | No Intervention | Control group receives only verbal instructions to train cognitive and physical conditions. Instructions will aim to promote daily and leisure activities. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-rehabilitation | Other | Each subject undergoes a combined rehabilitation protocol, which will be administered on a daily basis, designed to alternate physical exercises and cognitive training. Each daily session lasts between 30 and 45 minutes. The complete protocol lasts 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between the cognitive ability measured at the end of the treatment (time point 2 months) and at the screening time point | Changes in cognitive ability will be assessed by Montreal Cognitive Assessment (MoCA) Test (Conti et al., 2014) | At the screening time point and after 2 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance or improvement of the physical activity | Physical activity performed during the trial will be evaluated through the output of the actigraph device and physical performance using the Short Physical Performance Battery | At the screening time point and after 2 months of treatment |
| Copy and Recall of Rey's Figure |
Not provided
Inclusion criteria:
In case of MCI due to Alzheimer Disease (AD), additional inclusion criteria are:
In case of MCI due to Vascular Cognitive Impairment, additional inclusion criteria are:
Hachinski Ischemic score > 4
Fazekas score >=2
Presence of at least one of the following conditions, as assessed by TC scan or encephalic MRI
Exclusion Criteria:
Unreliable communication (eg, foreign language or aphasia)
Severe visual or auditory deficit, not reversible, to the extent that it compromises the interaction with the operator and the usage of ICT instrumentation.
Presence of neurological and/or psychiatric disorders (Hamilton scale >12) that might interfere with cognitive status
Left-handed individuals
Level of education <3 years
History of substance abuse (nicotine excluded)
Having relapsing systemic disease and presence of major head trauma
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudio Macchi, MD | University of Florence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation | Florence | 50141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28912076 | Background | Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12. | |
| 24005416 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Copy and Recall of Rey's Figure ( Caffarra et al., 2002) |
| At the screening time point and after 2 months of treatment |
| Verbal fluency task | Verbal fluency task (semantic - Novelli et al, 1986 - and phonemic - Carlesimo et al, 1996) | At the screening time point and after 2 months of treatment |
| Stroop Test | Stroop Test (short version; Caffarra et al., 2002) | At the screening time point and after 2 months of treatment |
| Serious Game test | Serious Game test (Zucchella et al, 2014) | At the screening time point and after 2 months of treatment |
| Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486. |
| 11976975 | Background | Caffarra P, Vezzadini G, Dieci F, Zonato F, Venneri A. Rey-Osterrieth complex figure: normative values in an Italian population sample. Neurol Sci. 2002 Mar;22(6):443-7. doi: 10.1007/s100720200003. |
| Background | C. Novelli, C. Papagno, E. Capitani, M. Laiacona, G. Vallar, S.F. Cappa Tre test clinici di ricerca e produzione lessicale: taratura su soggetti normalis Arch Psicol Neurol Psichiatr, 47 (1986), pp. 477-506 |
| 8954307 | Background | Carlesimo GA, Caltagirone C, Gainotti G. The Mental Deterioration Battery: normative data, diagnostic reliability and qualitative analyses of cognitive impairment. The Group for the Standardization of the Mental Deterioration Battery. Eur Neurol. 1996;36(6):378-84. doi: 10.1159/000117297. |
| 25473734 | Background | Zucchella C, Sinforiani E, Tassorelli C, Cavallini E, Tost-Pardell D, Grau S, Pazzi S, Puricelli S, Bernini S, Bottiroli S, Vecchi T, Sandrini G, Nappi G. Serious games for screening pre-dementia conditions: from virtuality to reality? A pilot project. Funct Neurol. 2014 Jul-Sep;29(3):153-8. |
| 25139107 | Background | Conti S, Bonazzi S, Laiacona M, Masina M, Coralli MV. Montreal Cognitive Assessment (MoCA)-Italian version: regression based norms and equivalent scores. Neurol Sci. 2015 Feb;36(2):209-14. doi: 10.1007/s10072-014-1921-3. Epub 2014 Aug 20. |
| 33329326 | Derived | Mosca IE, Salvadori E, Gerli F, Fabbri L, Pancani S, Lucidi G, Lombardi G, Bocchi L, Pazzi S, Baglio F, Vannetti F, Sorbi S, Macchi C. Analysis of Feasibility, Adherence, and Appreciation of a Newly Developed Tele-Rehabilitation Program for People With MCI and VCI. Front Neurol. 2020 Nov 27;11:583368. doi: 10.3389/fneur.2020.583368. eCollection 2020. |
| 30687208 | Derived | Fabbri L, Mosca IE, Gerli F, Martini L, Pancani S, Lucidi G, Savazzi F, Baglio F, Vannetti F, Macchi C; GOAL Working Group. The Games for Older Adults Active Life (GOAL) Project for People With Mild Cognitive Impairment and Vascular Cognitive Impairment: A Study Protocol for a Randomized Controlled Trial. Front Neurol. 2019 Jan 11;9:1040. doi: 10.3389/fneur.2018.01040. eCollection 2018. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided