Status:
COMPLETED
Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL)
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Consorzio di Bioingeneria e Informatica Medica
University of Florence
Conditions:
Cognitive Dysfunction
Mild Cognitive Impairment
Eligibility:
All Genders
65-80 years
Phase:
NA
Brief Summary
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 functi...
Detailed Description
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 conc...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age between 65 and 80 years old
- 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.
- In case of MCI due to Alzheimer Disease (AD), additional inclusion criteria are:
- 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
- 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
- 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:
- 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
- Frank dementia
- MMSE \<24
Exclusion
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03383549
Start Date
January 1 2018
End Date
June 30 2019
Last Update
January 29 2020
Active Locations (1)
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1
Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation
Florence, Italy, 50141