Financial Abilities in Neurological Diseases. Development of a Telerehabilitation Program: FINAGE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIRCCS San Camillo, Venezia, Italy
About this trial
Financial Abilities (FA) are a set of capacities that allow a person to independently manage her/his financial affairs in a manner consistent with personal self-interests and values. This project will: a) assess Financial Abilities in different neurological conditions: Mild Cognitive Impairment, Parkinson's disease and Stroke patients; b) investigate both cognitive correlations, specifically the role of executive functions, thought to be critically involved in the FA multi-dimensional concept, and neuro-anatomical correlates of Financial Abilities; c) build a rehabilitation tool in order to improve FA. Secondary aims are to apply this rehabilitation tool at long distance and evaluate its behavioral, functional and neuroanatomical effects. The starting point for this project is the recently published NADL-F - Numerical Activities of Daily Living - Financial, a multi-domain ecological battery aimed at assessing FA in healthy people as well as in neurological patient populations
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of: Mild Cognitive Impairment, Parkinson's disease and stroke
preserved use of at least one hand,
normal or corrected to normal vision
Disqualifiers
history of psychiatric and/or concurrent neurological diseases
inability to provide informed consent,
impaired comprehension of oral instructions,
Trial design
Design model
Parallel
Treatments tested in this trial
Telerehabilitation group
BehavioralPatients will undergo the experimental intervention for 1 hour/day, for 5 days, for 4 weeks.
Conventioanl treatment group
BehavioralPatients will undergo the control intervention for 1 hour/day, for 5 days, for 4 weeks.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Telerehabilitation groupExperimental treatment 1 intervention
Group B: Conventional treatment groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Correlational study
Performances at the NADL-F battery, assessing financial abilities, will be correlated to cognitive performances as assessed by a full neuropsychological battery encompassing the main cognitive domain, such as memory, attention, executive function, language, visuospatial abilities. Specific neuropsychological tests will be defined on the basis of the specific neurological population. Raw scores at each test will be converted in z-scores based on each test normative data. Z-scores will be averaged to calculate composite scores specific for each cognitive domain. In detail, the composite scores will be the following: general cognitive functioning, attention, executive function, short-term memory, long-term memory, visuospatial abilities, language. NADL-F scores will be then correlated also with structural (e.g., lesion mapping and/or voxel based morphometry) and functional measures (e.g., functional brain network connectivity).
Time frame
At baseline2
Measure of change in FA and cognitive abilities after a treatment with the telerehabilitation program FINAGE
The telerehabilitation program will be implemented on tablets (FINAGE). Exercises will focus on language, attention, memory, calculation, reasoning, gambling, executive function, theory of mind, testamentary abilities. Patients will complete 20 daily 1-hour sessions. Half of the patients will undergo the rehabilitation with FINAGE, the other half 20 sessions of standard cognitive rehabilitation. Cognitive performances will be assessed before and after treatment by a neuropsychological battery encompassing the main cognitive domains. Specific neuropsychological tests will be defined on the basis of the specific neurological population. Raw scores at each test will be converted in z-scores based on each test normative data. Z-scores will be averaged to calculate composite scores for each cognitive domain. The composite scores will be the following: general cognitive functioning, attention, executive function, short-term memory, long-term memory, visuospatial abilities, language.
Time frame
At baseline and after 4 weeks (post-intervention)3
Measure of change in brain connectivity after a treatment with the telerehabilitation program FINAGE
Patients will undergo a session of fMRI before and after treatment. The following variables will be extracted by neuroimaging data: whole-brain T1-based structural (surface, area, gyrification estimation in FreeSerfer) and resting-state fMRI-based functional connectivity (through Independent Component Analysis) properties of the main brain networks such as the fronto-parietal network, dorsal and ventral attention, salience and default-mode networks. MRI volumetric measurement (using automated routines in SPM12) of ROIs that previous literature has suggested to be linked to FA, at least in MCI, such as the angular gyri, will also be performed. Between subject independent variables will be pathology (PD, Stroke and MCI), type of treatment (TR, CT) and, when appropriate, session (pre- and post-treatment) will also be considered as the within-subject independent variable.
Time frame
At baseline and after 4 weeks (post-intervention)Sponsors and contacts
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IRCCS San Camillo, Venezia, Italy
Lead sponsor
Ministry of Health, Italy
Collaborator
Khymeia S.r.l.
Collaborator
University of Padova
Collaborator
Source ClinicalTrials.gov