NCT06290167

Brief Summary

The main objective of this project is two-fold

  1. 1.to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
  2. 2.to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

August 4, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

October 6, 2023

Last Update Submit

August 1, 2025

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (2)

  • Cognitive functions

    Improvement in cognitive functioning assessed with a complete neuropsychological battery focused on different domains such as executive function, memory, and attention.

    Immediately after the training experience

  • Motor functions

    Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed

    Immediately after the training experience

Study Arms (6)

360° media

EXPERIMENTAL

All participants will be randomly assigned to 360° media or TAU condition

Device: 360° media

Treatment As Usual (TAU)

ACTIVE COMPARATOR

All participants will be randomly assigned to TAU or 360° media condition

Other: Treatment As Usual (TAU)

In hospital sessions

OTHER

all participants will perform session in hospital

Other: In hospital sessions

at home sessions

OTHER

all participants will perform session at home

Other: at home sessions

Mild Cognitive Impairment

OTHER

half of the patients will have MCI

Other: Mild Cognitive Impairment

Subjective Memory Complain

OTHER

half of the patients will have SMC

Other: Subjective Memory Complain

Interventions

360° mediaDEVICE

sessions with head mounted display in hospital and sessions with tablet at home

360° media
Treatment As Usual (TAU)OTHER

sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home

Treatment As Usual (TAU)
In hospital sessionsOTHER

sessions will be carried out under the supervision of a therapist

In hospital sessions
at home sessionsOTHER

sessions will be carried out without the supervision of a therapist

at home sessions
Mild Cognitive ImpairmentOTHER

half of this group will perform the protocol with 360° videos and the other half will perform the TAU

Mild Cognitive Impairment
Subjective Memory ComplainOTHER

half of this group will perform the protocol with 360° videos and the other half will perform the TAU

Subjective Memory Complain

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \> 65 years old
  • self-reported memory complaints
  • score on Mini-Mental State Examination greater than or equal to 27/30 (normal range)

You may not qualify if:

  • no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating \< 0.5
  • \> 65 years old
  • a self-reported (or reported by a caregiver) cognitive decline
  • an objective impairment on the neuropsychological testing
  • scores on the Clinical Dementia Rating \< 0.5.
  • no dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, MI, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Elisa Pedroli, PsyD

CONTACT

02 61911 2707e.pedroli@auxologico.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2023

First Posted

March 4, 2024

Study Start

July 3, 2023

Primary Completion

April 10, 2026

Study Completion

April 10, 2026

Last Updated

August 4, 2025

Record last verified: 2025-08

Locations

IT(1)