Active Navigation Training

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Spatial Navigation
• Interventions: Other: TAU; Other: CAVE

• Registration Number: NCT05768620
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-14
• Primary Completion: 2023-04-01
• Study Completion: 2023-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU	TAU	10 paper and pencil sessions to train spatial memory
CAVE	CAVE	10 immersive virtual reality sessions to train spatial memory

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Digit span forward	After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up
Trail-making test part A and B	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
Corsi Block Tapping	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

Trial Locations

Locations (1)

Cosimo Tuena; 🇮🇹 Milan, Lombardia, Italy