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Active Navigation Training

NCT ID: NCT05768620

Last Updated: 2023-11-27

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-07-01

Brief Summary

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Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.

Detailed Description

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Conditions

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Mild Cognitive Impairment Spatial Navigation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Proof-of-concept trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CAVE

10 immersive virtual reality sessions to train spatial memory

Group Type EXPERIMENTAL

CAVE

Intervention Type OTHER

The training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes

TAU

10 paper and pencil sessions to train spatial memory

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type OTHER

This is the usual care used to train visuospatial processes

Interventions

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CAVE

The training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes

Intervention Type OTHER

TAU

This is the usual care used to train visuospatial processes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of mild cognitive impairment
* absence of severe cognitive deterioration as assessed by the Italian version of the MMSE (Magni et al. 1996)
* age ≥ 60

Exclusion Criteria

* the presence of acute stroke/transient ischemic attack;
* the presence of other concomitants severe neurological/psychiatric diseases;
* history of traumatic brain injury with loss of consciousness;
* physical/functional deficits that could affect the use of immersive virtual reality;
* severe visual deficiency;
* the presence of recurrent vertigo.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cosimo Tuena

Milan, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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39M801

Identifier Type: -

Identifier Source: org_study_id