Telerehabilitation in Mild Cognitive Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2024-06-30

Brief Summary

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The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS) compared to usual care treatment for patients with Mild Cognitive Impairment (MCI). Moreover, we will assess the possibility to prolong the beneficial effects of the treatment with an innovative telerehabilitation system. In the second phase of the present study we aim to evaluate the short and long term effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex combined with VRRS compared to placebo tDCS stimulation combined with VRRS.

The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with five groups. The investigators will assess the effects of VRRS system and of the implementation of the at-home treatment on the quality of life, cognitive and functional abilities.

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Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Face to Face VRRS and telerehabilitation

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Group Type EXPERIMENTAL

Face to Face VRRS and telerehabilitation

Intervention Type BEHAVIORAL

Face to Face cognitive training using VRRS plus telerehabilitation. Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.

The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).

Usual rehabilitation program

The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.

Group Type ACTIVE_COMPARATOR

Usual rehabilitation program

Intervention Type BEHAVIORAL

The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.

FTF VRRS plus unstructured CS

Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week.

Group Type ACTIVE_COMPARATOR

FTF VRRS plus unstructured CS

Intervention Type BEHAVIORAL

Face to Face cognitive training using VRRS plus at-home unstructured cognitive stimulation.

Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week.

Face to Face VRRS plus active tDCS and telerehabilitation

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Group Type EXPERIMENTAL

Face to Face VRRS plus active tDCS and telerehabilitation

Intervention Type BEHAVIORAL

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.

The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).

Face to Face VRRS plus placebo tDCS and telerehabilitation

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Group Type ACTIVE_COMPARATOR

Face to Face VRRS plus placebo tDCS and telerehabilitation

Intervention Type BEHAVIORAL

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.

The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).

Interventions

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Face to Face VRRS and telerehabilitation

Face to Face cognitive training using VRRS plus telerehabilitation. Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.

The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).

Intervention Type BEHAVIORAL

Usual rehabilitation program

The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.

Intervention Type BEHAVIORAL

FTF VRRS plus unstructured CS

Face to Face cognitive training using VRRS plus at-home unstructured cognitive stimulation.

Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week.

Intervention Type BEHAVIORAL

Face to Face VRRS plus active tDCS and telerehabilitation

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.

The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).

Intervention Type BEHAVIORAL

Face to Face VRRS plus placebo tDCS and telerehabilitation

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.

The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of MCI, defined according to standard criteria (Petersen et al., 2011)
* Mini Mental State Examination (MMSE) ≥24
* Education ≥ 5 years
* All of the subjects will have normal or corrected-to-normal vision and will be native Italian speakers.
* All participants reported subjective memory complaints and objective memory impairment, but no impairment of function in daily life.

Exclusion Criteria

* visual perception disorder and/or hearing loss
* history of major psychiatric disorders
* any contraindication for tDCS such as a history of seizures, major head trauma, past brain surgery, a brain metal implant or a pacemaker.

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No