Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL)

NCT03383549 | Completed

• 1 other identifier: DongnocchiGOAL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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]

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Maintenance or improvement of the physical activity

  At the screening time point and after 2 months of treatment

• Copy and Recall of Rey's Figure

  At the screening time point and after 2 months of treatment

• Verbal fluency task

  At the screening time point and after 2 months of treatment

• Stroop Test

  At the screening time point and after 2 months of treatment

• Serious Game test

  At the screening time point and after 2 months of treatment

Study Arms (2)

Tele-rehabilitation

EXPERIMENTAL

Tele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises

Other: Tele-rehabilitation

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.

Interventions

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.

Tele-rehabilitation

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Consorzio di Bioingeneria e Informatica Medica: collaborator
• University of Florence: collaborator
• Gutenberg Srl: collaborator

Study Sites (1)

Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation

Florence, 50141, Italy

Location

Related Publications (9)

• 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.

  PMID: 28912076 BACKGROUND

• 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.

  PMID: 24005416 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.

  PMID: 11976975 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

  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.

  PMID: 8954307 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.

  PMID: 25473734 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.

  PMID: 25139107 BACKGROUND

• 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.

  PMID: 33329326 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.

  PMID: 30687208 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Claudio Macchi, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 26, 2017
• Study Start: January 1, 2018
• Primary Completion: October 30, 2018
• Study Completion: June 30, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

IT (1)