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

Not Applicable

Completed

• Conditions: Vascular Cognitive Impairment; Cognitive Dysfunction; Mild Cognitive Impairment
• Interventions: Other: Tele-rehabilitation

• Registration Number: NCT03383549
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Study Timeline

• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Study Start: 2018-01-01
• Primary Completion: 2018-10-30
• Study Completion: 2019-06-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Comparison between the cognitive ability measured at the end of the treatment (time point 2 months) and at the screening time point	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)

Secondary Outcome Measures

Name	Time	Method
Copy and Recall of Rey's Figure	At the screening time point and after 2 months of treatment	Copy and Recall of Rey's Figure ( Caffarra et al., 2002)
Verbal fluency task	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)
Serious Game test	At the screening time point and after 2 months of treatment	Serious Game test (Zucchella et al, 2014)
Maintenance or improvement of the physical activity	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
Stroop Test	At the screening time point and after 2 months of treatment	Stroop Test (short version; Caffarra et al., 2002)

Trial Locations

Locations (1)

Rehabilitation Centre IRCCS Don Carlo Gnocchi Foundation; 🇮🇹 Florence, Italy