A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab

NCT ID: NCT06290167

Last Updated: 2025-08-04

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-03

Study Completion Date

2026-04-10

Brief Summary

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The main objective of this project is two-fold

1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
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.

Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.

Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments.

Detailed Description

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Conditions

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Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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360° media

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

Group Type EXPERIMENTAL

360° media

Intervention Type DEVICE

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

Treatment As Usual (TAU)

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

Group Type ACTIVE_COMPARATOR

Treatment As Usual (TAU)

Intervention Type OTHER

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

In hospital sessions

all participants will perform session in hospital

Group Type OTHER

In hospital sessions

Intervention Type OTHER

sessions will be carried out under the supervision of a therapist

at home sessions

all participants will perform session at home

Group Type OTHER

at home sessions

Intervention Type OTHER

sessions will be carried out without the supervision of a therapist

Mild Cognitive Impairment

half of the patients will have MCI

Group Type OTHER

Mild Cognitive Impairment

Intervention Type OTHER

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

Subjective Memory Complain

half of the patients will have SMC

Group Type OTHER

Subjective Memory Complain

Intervention Type OTHER

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

Interventions

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360° media

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

Intervention Type DEVICE

Treatment As Usual (TAU)

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

Intervention Type OTHER

In hospital sessions

sessions will be carried out under the supervision of a therapist

Intervention Type OTHER

at home sessions

sessions will be carried out without the supervision of a therapist

Intervention Type OTHER

Mild Cognitive Impairment

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

Intervention Type OTHER

Subjective Memory Complain

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


* \> 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.

Exclusion Criteria

* no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating \< 0.5


* no dementia
Minimum Eligible Age

65 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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Istituto Auxologico Italiano IRCCS

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elisa Pedroli, PsyD

Role: CONTACT

02 61911 2707

Facility Contacts

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Elisa Pedroli, PsyD

Role: primary

02 61911 2707

Other Identifiers

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30M201

Identifier Type: -

Identifier Source: org_study_id

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