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

January 28, 2020 updated by: Fondazione Don Carlo Gnocchi Onlus

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50141
        • Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tele-rehabilitation
Tele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises
Other: Tele-rehabilitation
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.
No Intervention: Control group
Control group receives only verbal instructions to train cognitive and physical conditions. Instructions will aim to promote daily and leisure activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance or improvement of the physical activity
Time Frame: At the screening time point and after 2 months of treatment
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
At the screening time point and after 2 months of treatment
Copy and Recall of Rey's Figure
Time Frame: At the screening time point and after 2 months of treatment
Copy and Recall of Rey's Figure ( Caffarra et al., 2002)
At the screening time point and after 2 months of treatment
Verbal fluency task
Time Frame: At the screening time point and after 2 months of treatment
Verbal fluency task (semantic - Novelli et al, 1986 - and phonemic - Carlesimo et al, 1996)
At the screening time point and after 2 months of treatment
Stroop Test
Time Frame: At the screening time point and after 2 months of treatment
Stroop Test (short version; Caffarra et al., 2002)
At the screening time point and after 2 months of treatment
Serious Game test
Time Frame: At the screening time point and after 2 months of treatment
Serious Game test (Zucchella et al, 2014)
At the screening time point and after 2 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

University of Florence
Consorzio di Bioingeneria e Informatica Medica
Gutenberg Srl

Investigators

  • Principal Investigator: Claudio Macchi, MD, University of Florence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DongnocchiGOAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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