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
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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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-07-03
2026-04-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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360° media
All participants will be randomly assigned to 360° media or TAU condition
360° media
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
Treatment As Usual (TAU)
sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home
In hospital sessions
all participants will perform session in hospital
In hospital sessions
sessions will be carried out under the supervision of a therapist
at home sessions
all participants will perform session at home
at home sessions
sessions will be carried out without the supervision of a therapist
Mild Cognitive Impairment
half of the patients will have MCI
Mild Cognitive Impairment
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
Subjective Memory Complain
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
Treatment As Usual (TAU)
sessions of TAU rehabilitation in hospital and sessions TAU rehabilitation at home
In hospital sessions
sessions will be carried out under the supervision of a therapist
at home sessions
sessions will be carried out without the supervision of a therapist
Mild Cognitive Impairment
half of this group will perform the protocol with 360° videos and the other half will perform the TAU
Subjective Memory Complain
half of this group will perform the protocol with 360° videos and the other half will perform the TAU
Eligibility Criteria
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Inclusion Criteria
* 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 dementia
65 Years
ALL
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Locations
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Istituto Auxologico Italiano IRCCS
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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30M201
Identifier Type: -
Identifier Source: org_study_id
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