Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL)
NCT ID: NCT03383549
Last Updated: 2020-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-01-01
2019-06-30
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Tele-rehabilitation
Tele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises
Tele-rehabilitation
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.
Control group
Control group receives only verbal instructions to train cognitive and physical conditions. Instructions will aim to promote daily and leisure activities.
No interventions assigned to this group
Interventions
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Tele-rehabilitation
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.
Eligibility Criteria
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Inclusion Criteria
* Agreement to participate, with signature of the informed-consent form
* Availability of a caregiver/study partner, who agrees to support the participant through the GOAL program. Participant and caregiver are not required to live together
* Mini Mental State Examination (MMSE) score \>24 The participant should present a mild cognitive impairment (MCI) in absence of secondary causes of dementia (hypothyroidism untreated or treated with a therapy that has been revised in the previous 6 months, vitamin B12 or folate deficiency), assessed through a blood test.
* Hachinski Ischemic Score ≤4
* Absence of secondary causes of dementia confirmed by a neuroimaging examination (TC scan or encephalic MRI), Fazekas score \<2
* Biomarker of neuronal damage (PET with 18f-fluorodeoxyglucose, MRI with hippocampal volumetric assessment or levels of t-tau and p-tau in the cerebrospinal fluid) or biomarkers of Aβ deposition (Amyloid-PET or levels of A\> 42 in the cerebrospinal fluid) consistent with MCI due to AD
* Hachinski Ischemic score \> 4
* Fazekas score \>=2
* Presence of at least one of the following conditions, as assessed by TC scan or encephalic MRI
* Multiple lesions in the white matter consistent with cerebral small vessel disease
* Lacunar status
* Multi-infarct encephalopathy with ischemic multiple lesions in the cortical region, in the basal ganglia and white matter
Exclusion Criteria
* 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
* Frank dementia
* MMSE \<24
65 Years
80 Years
ALL
Yes
Sponsors
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Consorzio di Bioingeneria e Informatica Medica
UNKNOWN
University of Florence
OTHER
Gutenberg Srl
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Principal Investigators
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Claudio Macchi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florence
Locations
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Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation
Florence, , Italy
Countries
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References
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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.
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.
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.
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
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.
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.
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.
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.
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.
Other Identifiers
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DongnocchiGOAL
Identifier Type: -
Identifier Source: org_study_id
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