Active Navigation Training

Study Overview
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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.

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

Conditions
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Mild Cognitive Impairment, Spatial Navigation

Intervention / Treatment
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* Other: CAVE
* Other: TAU


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Proof-of-concept trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality