Back to resultsCognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL) (GOAL)
Primary Purpose
Cognitive Dysfunction, Mild Cognitive Impairment, Vascular Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tele-rehabilitation
Sponsored by
About this trial
This is an interventional health services research trial for Cognitive Dysfunction focused on measuring Telerehabilitation [E02.831.891], Cognitive Aging [G07.345.124.260], Exercise Therapy [E02.760.169.063.500.387]
Eligibility Criteria
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
Sites / Locations
- Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tele-rehabilitation
Control group
Arm Description
Tele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises
Control group receives only verbal instructions to train cognitive and physical conditions. Instructions will aim to promote daily and leisure activities.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Copy and Recall of Rey's Figure
Copy and Recall of Rey's Figure ( Caffarra et al., 2002)
Verbal fluency task
Verbal fluency task (semantic - Novelli et al, 1986 - and phonemic - Carlesimo et al, 1996)
Stroop Test
Stroop Test (short version; Caffarra et al., 2002)
Serious Game test
Serious Game test (Zucchella et al, 2014)
Full Information
NCT ID
NCT03383549
First Posted
December 15, 2017
Last Updated
January 28, 2020
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Consorzio di Bioingeneria e Informatica Medica, University of Florence, Gutenberg Srl
1. Study Identification
Unique Protocol Identification Number
NCT03383549
Brief Title
Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL)
Acronym
GOAL
Official Title
Home-rehabilitation Protocol in Elderly Subjects With Mild Cognitive Impairment (MCI) Based on Information and Communications Technology (ICT) and Serious Games for Cognitive and Physical Training. Games for Older Adults Active Life (GOAL)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Consorzio di Bioingeneria e Informatica Medica, University of Florence, Gutenberg Srl
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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).
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction, Mild Cognitive Impairment, Vascular Cognitive Impairment
Keywords
Telerehabilitation [E02.831.891], Cognitive Aging [G07.345.124.260], Exercise Therapy [E02.760.169.063.500.387]
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-rehabilitation
Arm Type
Experimental
Arm Description
Tele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group receives only verbal instructions to train cognitive and physical conditions. Instructions will aim to promote daily and leisure activities.
Intervention Type
Other
Intervention Name(s)
Tele-rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison between the cognitive ability measured at the end of the treatment (time point 2 months) and at the screening time point
Description
Changes in cognitive ability will be assessed by Montreal Cognitive Assessment (MoCA) Test (Conti et al., 2014)
Time Frame
At the screening time point and after 2 months of treatment
Secondary Outcome Measure Information:
Title
Maintenance or improvement of the physical activity
Description
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
Time Frame
At the screening time point and after 2 months of treatment
Title
Copy and Recall of Rey's Figure
Description
Copy and Recall of Rey's Figure ( Caffarra et al., 2002)
Time Frame
At the screening time point and after 2 months of treatment
Title
Verbal fluency task
Description
Verbal fluency task (semantic - Novelli et al, 1986 - and phonemic - Carlesimo et al, 1996)
Time Frame
At the screening time point and after 2 months of treatment
Title
Stroop Test
Description
Stroop Test (short version; Caffarra et al., 2002)
Time Frame
At the screening time point and after 2 months of treatment
Title
Serious Game test
Description
Serious Game test (Zucchella et al, 2014)
Time Frame
At the screening time point and after 2 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Macchi, MD
Organizational Affiliation
University of Florence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation
City
Florence
ZIP/Postal Code
50141
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28912076
Citation
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.
Results Reference
background
PubMed Identifier
24005416
Citation
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.
Results Reference
background
PubMed Identifier
11976975
Citation
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.
Results Reference
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Citation
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
Results Reference
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PubMed Identifier
8954307
Citation
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.
Results Reference
background
PubMed Identifier
25473734
Citation
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.
Results Reference
background
PubMed Identifier
25139107
Citation
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.
Results Reference
background
PubMed Identifier
33329326
Citation
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.
Results Reference
derived
PubMed Identifier
30687208
Citation
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.
Results Reference
derived
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Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL)
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