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Cognitive DysfunctionGOALNCT03383549

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

A study testing Tele-rehabilitation in people with Cognitive Dysfunction and Mild Cognitive Impairment, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 to 80 yearsHealthy volunteers can take part
What is being tested?
Tele-rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
1 Jan 2018to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • Having relapsing systemic disease and presence of major head trauma
  • Frank dementia
  • MMSE <24

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation

    Florence, 50141

Other trials in Italy

About this study

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)

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.

Read more

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).

Read the 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.

Being tested
Tele-rehabilitation
Keywords
Telerehabilitation [E02.831.891], Cognitive Aging [G07.345.124.260], Exercise Therapy [E02.760.169.063.500.387]
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-rehabilitationOther

    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.

Study groups in NCT03383549
Study groupRoleWhat they receive
Tele-rehabilitationExperimentalTele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises
Receives: Other: Tele-rehabilitation
Control groupNo interventionControl group receives only verbal instructions to train cognitive and physical conditions. Instructions will aim to promote daily and leisure activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: At the screening time point and after 2 months of treatment

Secondary outcomes (5)

  1. 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

    Measured: At the screening time point and after 2 months of treatment

  2. Copy and Recall of Rey's Figure

    Copy and Recall of Rey's Figure ( Caffarra et al., 2002)

    Measured: At the screening time point and after 2 months of treatment

  3. Verbal fluency task

    Verbal fluency task (semantic - Novelli et al, 1986 - and phonemic - Carlesimo et al, 1996)

    Measured: At the screening time point and after 2 months of treatment

  4. Stroop Test

    Stroop Test (short version; Caffarra et al., 2002)

    Measured: At the screening time point and after 2 months of treatment

  5. Serious Game test

    Serious Game test (Zucchella et al, 2014)

    Measured: At the screening time point and after 2 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2017
  2. Study start1 Jan 2018
  3. Primary completion30 Oct 2018
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03383549
Sponsor's protocol ID
DongnocchiGOAL
Acronym
GOAL
Status last verified
Jan 2020
First submitted
15 Dec 2017
Last updated
29 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28912076

  • 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.

    PubMed 24005416

  • 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.

    PubMed 11976975

  • 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.

    PubMed 8954307

  • 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.

    PubMed 25473734

  • 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.

    PubMed 25139107

  • 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.

    PubMed 33329326

  • 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.

    PubMed 30687208

Questions about this trial

What is this clinical trial studying?

A study testing Tele-rehabilitation in people with Cognitive Dysfunction and Mild Cognitive Impairment, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison between the cognitive ability measured at the end of the treatment (time point 2 months) and at the screening time point (time frame: At the screening time point and after 2 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03383549, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.

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