Active Navigation Training (ANTaging)

Active Navigation Training: an Innovative Embodied-based Training System for Spatial Navigation in Aging

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

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Spatial Navigation
• Intervention / Treatment: Other: CAVE; Other: TAU

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Milan, Lombardia, Italy, 20145
      • Cosimo Tuena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAVE; 10 immersive virtual reality sessions to train spatial memory	Other: CAVE; The training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes
Active Comparator: TAU; 10 paper and pencil sessions to train spatial memory	Other: TAU; This is the usual care used to train visuospatial processes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Corsi supra-span test	Scores range from 0 to 29.16, higher scores indicate better visuospatial learning	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Change in Manikin Test	Scores range from 0 to 1, higher scores indicate better visuospatial mental rotation	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Trail-making test part A and B	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Raccontino (6 Dicembre) (immediate-delayed-forgetting)	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Mini-mental state examination	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Digit span forward	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Corsi Block Tapping	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 39M801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No